Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT03569293
Status:
COMPLETED
Last Update Posted:
2025-10-24
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613732', 'term': 'upadacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.', 'eventGroups': [{'id': 'EG000', 'title': 'Adults: Placebo', 'description': 'Participants ≥ 18 years old received placebo orally once a day for 16 weeks.', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 64, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Adults: Upadacitinib 15 mg QD', 'description': 'Participants ≥ 18 years old received upadacitinib 15 mg orally once daily for 16 weeks.', 'otherNumAtRisk': 239, 'deathsNumAtRisk': 239, 'otherNumAffected': 67, 'seriousNumAtRisk': 239, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Adults: Upadacitinib 30 mg QD', 'description': 'Participants ≥ 18 years old received upadacitinib 30 mg orally once daily for 16 weeks.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 102, 'seriousNumAtRisk': 243, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants (12 - 17 years old) received placebo orally once a day (QD) for 16 weeks.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 13, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants (12 - 17 years old) received upadacitinib 15 mg orally once daily for 16 weeks.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 19, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants (12 - 17 years old) received upadacitinib 30 mg orally once daily for 16 weeks.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 25, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 42, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'DERMATITIS ATOPIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'seriousEvents': [{'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ANAPHYLACTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'FOOD ALLERGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'IMPETIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'PHARYNGEAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'PNEUMONIA STAPHYLOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'CARTILAGE INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'TENDON RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'GASTRIC CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'INVASIVE DUCTAL BREAST CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'DERMATITIS ATOPIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'DERMATITIS EXFOLIATIVE GENERALISED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '20.7'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '64.2', 'upperLimit': '75.0'}, {'value': '79.7', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '84.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.4', 'ciLowerLimit': '57.1', 'ciUpperLimit': '69.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.3', 'ciLowerLimit': '46.4', 'ciUpperLimit': '60.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat population for the main study (ITT\\_M) includes all participants who were randomized in the main study (adults and adolescents). Non-responder imputation incorporating multiple imputation to handle missing data due to coronavirus disease 2019 pandemic (COVID-19) (NRI-C) was used.\n\nThe pre-specified primary analysis included participants enrolled in the main study only; Efficacy analyses of adolescent participants were conducted separately and are reported below.'}, {'type': 'PRIMARY', 'title': 'Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '11.7'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '54.0'}, {'value': '62.0', 'groupId': 'OG002', 'lowerLimit': '56.4', 'upperLimit': '67.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.6', 'ciLowerLimit': '47.2', 'ciUpperLimit': '60.0', 'estimateComment': 'Response rate difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.8', 'ciLowerLimit': '33.2', 'ciUpperLimit': '46.4', 'estimateComment': 'Response rate difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No inflammatory signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '15.6'}, {'value': '52.2', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '58.1'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '54.3', 'upperLimit': '65.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.2', 'ciLowerLimit': '41.3', 'ciUpperLimit': '55.0', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.5', 'ciLowerLimit': '33.5', 'ciUpperLimit': '47.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '11.3'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '58.9'}, {'value': '65.8', 'groupId': 'OG002', 'lowerLimit': '60.2', 'upperLimit': '71.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.8', 'ciLowerLimit': '51.5', 'ciUpperLimit': '64.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '38.6', 'ciUpperLimit': '51.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.9'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '45.5', 'upperLimit': '57.4'}, {'value': '66.8', 'groupId': 'OG002', 'lowerLimit': '61.3', 'upperLimit': '72.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '62.3', 'ciLowerLimit': '56.3', 'ciUpperLimit': '68.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.1', 'ciLowerLimit': '40.7', 'ciUpperLimit': '53.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '5.7'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '43.8'}, {'value': '47.4', 'groupId': 'OG002', 'lowerLimit': '41.6', 'upperLimit': '53.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.9', 'ciLowerLimit': '37.7', 'ciUpperLimit': '50.0', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.5', 'ciLowerLimit': '28.6', 'ciUpperLimit': '40.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '19.2'}, {'value': '19.6', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '24.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.2', 'ciLowerLimit': '14.6', 'ciUpperLimit': '23.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '10.3', 'ciUpperLimit': '18.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.0'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '14.2'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '15.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '3.8', 'ciUpperLimit': '12.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 2', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).\n\nThe percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (daily score) ≥ 4 at Baseline; Non-responder imputation with no special data handling for missing data due to COVID-19 (NRI-NC) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '279', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '5.5'}, {'value': '16.4', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '20.7'}, {'value': '21.1', 'groupId': 'OG002', 'lowerLimit': '16.4', 'upperLimit': '25.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '8.1', 'ciUpperLimit': '17.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 3', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).\n\nThe percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with Worst Pruritus NRS (daily score) ≥ 4 at Baseline; Non-responder imputation with no special data handling for missing data due to COVID-19 (NRI-NC) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '30.3'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0.0', 'comment': 'Could not be calculated using the normal approximation to the binomial distribution', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.2', 'ciLowerLimit': '-30.3', 'ciUpperLimit': '-20.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.1', 'ciLowerLimit': '-29.3', 'ciUpperLimit': '-18.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug to Week 16', 'description': 'A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with an EASI score ≤ 65.4 at Baseline and at least one EASI post-baseline assessment prior to use of rescue medication.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '17.7'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '61.6'}, {'value': '66.1', 'groupId': 'OG002', 'lowerLimit': '59.8', 'upperLimit': '72.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.9', 'ciLowerLimit': '45.2', 'ciUpperLimit': '60.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.8', 'ciLowerLimit': '33.9', 'ciUpperLimit': '49.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nThe ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.\n\nThe minimal clinically important difference for ADerm-IS sleep domain score is 12.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with ADerm-IS Sleep Domain score ≥ 12 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '19.6'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '59.9'}, {'value': '63.5', 'groupId': 'OG002', 'lowerLimit': '57.5', 'upperLimit': '69.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.6', 'ciLowerLimit': '41.0', 'ciUpperLimit': '56.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.7', 'ciLowerLimit': '30.9', 'ciUpperLimit': '46.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with ADerm-SS Skin Pain Score ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '19.7'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '60.1'}, {'value': '67.9', 'groupId': 'OG002', 'lowerLimit': '62.1', 'upperLimit': '73.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.9', 'ciLowerLimit': '45.4', 'ciUpperLimit': '60.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.3', 'ciLowerLimit': '30.4', 'ciUpperLimit': '46.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with ADerm-SS TSS-7 ≥ 28 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '25.2'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '56.3', 'upperLimit': '68.9'}, {'value': '72.6', 'groupId': 'OG002', 'lowerLimit': '66.7', 'upperLimit': '78.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.5', 'ciLowerLimit': '44.7', 'ciUpperLimit': '60.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.7', 'ciLowerLimit': '34.4', 'ciUpperLimit': '50.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS emotional state sums three items \\[Items 8-10\\] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.\n\nThe minimal clinically important difference for ADerm-IS emotional state domain score is 11.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with ADerm-IS Emotional State domain score ≥ 11 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '25.9'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '58.5', 'upperLimit': '71.6'}, {'value': '73.2', 'groupId': 'OG002', 'lowerLimit': '67.1', 'upperLimit': '79.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.1', 'ciLowerLimit': '44.9', 'ciUpperLimit': '61.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.7', 'ciLowerLimit': '36.2', 'ciUpperLimit': '53.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.\n\nThe minimal clinically important difference for the ADerm-IS daily activities domain score is 14.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with ADerm-IS Daily Activities Domain Score ≥ 14 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.3'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '21.1'}, {'value': '27.0', 'groupId': 'OG002', 'lowerLimit': '21.9', 'upperLimit': '32.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.3', 'ciLowerLimit': '20.0', 'ciUpperLimit': '30.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '10.4', 'ciUpperLimit': '19.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.06', 'groupId': 'OG000', 'lowerLimit': '-36.66', 'upperLimit': '-15.46'}, {'value': '-62.79', 'groupId': 'OG001', 'lowerLimit': '-71.60', 'upperLimit': '-53.99'}, {'value': '-72.04', 'groupId': 'OG002', 'lowerLimit': '-80.69', 'upperLimit': '-63.39'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.98', 'ciLowerLimit': '-58.82', 'ciUpperLimit': '-33.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.549', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.74', 'ciLowerLimit': '-49.66', 'ciUpperLimit': '-23.81', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percent Change From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.71', 'groupId': 'OG000', 'lowerLimit': '-45.18', 'upperLimit': '-36.23'}, {'value': '-80.24', 'groupId': 'OG001', 'lowerLimit': '-83.99', 'upperLimit': '-76.49'}, {'value': '-87.74', 'groupId': 'OG002', 'lowerLimit': '-91.42', 'upperLimit': '-84.06'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.03', 'ciLowerLimit': '-52.37', 'ciUpperLimit': '-41.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.716', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.53', 'ciLowerLimit': '-44.91', 'ciUpperLimit': '-34.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.738', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '27.8'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '69.9', 'upperLimit': '80.1'}, {'value': '81.4', 'groupId': 'OG002', 'lowerLimit': '76.9', 'upperLimit': '86.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.6', 'ciLowerLimit': '51.9', 'ciUpperLimit': '65.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.3', 'ciLowerLimit': '45.2', 'ciUpperLimit': '59.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with POEM score ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '23.3', 'upperLimit': '34.7'}, {'value': '75.4', 'groupId': 'OG001', 'lowerLimit': '70.1', 'upperLimit': '80.8'}, {'value': '82.0', 'groupId': 'OG002', 'lowerLimit': '77.3', 'upperLimit': '86.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.2', 'ciLowerLimit': '45.9', 'ciUpperLimit': '60.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.7', 'ciLowerLimit': '39.0', 'ciUpperLimit': '54.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study who were ≥ 16 years old at Screening with DLQI score ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.68', 'groupId': 'OG000', 'lowerLimit': '-37.26', 'upperLimit': '-28.11'}, {'value': '-65.71', 'groupId': 'OG001', 'lowerLimit': '-69.20', 'upperLimit': '-62.23'}, {'value': '-73.07', 'groupId': 'OG002', 'lowerLimit': '-76.47', 'upperLimit': '-69.68'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.39', 'ciLowerLimit': '-45.75', 'ciUpperLimit': '-35.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.732', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.03', 'ciLowerLimit': '-38.44', 'ciUpperLimit': '-27.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.758', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements (MMRM) including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '20.4'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '37.4', 'upperLimit': '53.6'}, {'value': '49.2', 'groupId': 'OG002', 'lowerLimit': '41.0', 'upperLimit': '57.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.9', 'ciLowerLimit': '24.8', 'ciUpperLimit': '45.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.5', 'ciLowerLimit': '21.4', 'ciUpperLimit': '41.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Upadacitinib 15 mg QD', 'description': 'Participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Upadacitinib 30 mg QD', 'description': 'Participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '7.0'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '35.9'}, {'value': '41.5', 'groupId': 'OG002', 'lowerLimit': '35.5', 'upperLimit': '47.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.3', 'ciLowerLimit': '30.8', 'ciUpperLimit': '43.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.9', 'ciLowerLimit': '19.7', 'ciUpperLimit': '32.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \\[adolescent vs. adult\\])', 'nonInferiorityComment': 'The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for the main study who were ≥ 16 years old at Screening with DLQI score ≥ 1 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '19.5'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '62.6', 'upperLimit': '84.3'}, {'value': '78.1', 'groupId': 'OG002', 'lowerLimit': '68.0', 'upperLimit': '88.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.6', 'ciLowerLimit': '53.8', 'ciUpperLimit': '79.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '62.0', 'ciLowerLimit': '48.6', 'ciUpperLimit': '75.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population for adolescents (ITT\\_A) consists of all adolescent participants who are randomized in the main study or the adolescent sub-study. Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '12.8'}, {'value': '45.3', 'groupId': 'OG001', 'lowerLimit': '33.1', 'upperLimit': '57.5'}, {'value': '64.1', 'groupId': 'OG002', 'lowerLimit': '52.3', 'upperLimit': '75.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.4', 'ciLowerLimit': '44.6', 'ciUpperLimit': '70.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.1', 'ciLowerLimit': '25.6', 'ciUpperLimit': '52.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '17.6'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '60.8'}, {'value': '56.5', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '68.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.6', 'ciLowerLimit': '32.6', 'ciUpperLimit': '60.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.7', 'ciLowerLimit': '24.3', 'ciUpperLimit': '53.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '59.1'}, {'value': '67.2', 'groupId': 'OG002', 'lowerLimit': '55.7', 'upperLimit': '78.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '63.9', 'ciLowerLimit': '51.8', 'ciUpperLimit': '75.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.8', 'ciLowerLimit': '30.9', 'ciUpperLimit': '56.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '60.8'}, {'value': '58.1', 'groupId': 'OG002', 'lowerLimit': '45.8', 'upperLimit': '70.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.7', 'ciLowerLimit': '41.7', 'ciUpperLimit': '67.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.2', 'ciLowerLimit': '32.0', 'ciUpperLimit': '58.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '51.0'}, {'value': '50.4', 'groupId': 'OG002', 'lowerLimit': '38.0', 'upperLimit': '62.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.1', 'ciLowerLimit': '34.0', 'ciUpperLimit': '60.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.9', 'ciLowerLimit': '23.2', 'ciUpperLimit': '48.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'comment': 'Could not be calculated using the normal approximation to the binomial distribution', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '17.0'}, {'value': '21.0', 'groupId': 'OG002', 'lowerLimit': '10.8', 'upperLimit': '31.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '11.0', 'ciUpperLimit': '31.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.4', 'ciLowerLimit': '2.5', 'ciUpperLimit': '16.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '15.3'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '20.9'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '2.1', 'ciUpperLimit': '19.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '13.9', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 2', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (daily score) ≥ 4 at Baseline; Non-responder imputation with no special data handling for missing data due to COVID-19 was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.7'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '26.1'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '24.9'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '0.2', 'ciUpperLimit': '21.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '0.5', 'ciUpperLimit': '21.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 3', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with Worst Pruritus NRS (daily score) ≥ 4 at Baseline; Non-responder imputation with no special data handling for missing data due to COVID-19 was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '32.6'}, {'value': '0.0', 'comment': 'Could not be calculated using the normal approximation to the binomial distribution', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'Could not be calculated using the normal approximation to the binomial distribution', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.1', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '-11.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.1', 'ciLowerLimit': '-32.7', 'ciUpperLimit': '-11.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug to Week 16', 'description': 'A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with an EASI score ≤ 65.4 at Baseline and at least one EASI post-baseline assessment prior to use of rescue medication.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '21.9'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '33.0', 'upperLimit': '60.9'}, {'value': '66.0', 'groupId': 'OG002', 'lowerLimit': '52.4', 'upperLimit': '79.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.6', 'ciLowerLimit': '37.7', 'ciUpperLimit': '69.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.8', 'ciLowerLimit': '18.1', 'ciUpperLimit': '51.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nThe ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.\n\nThe minimal clinically important difference for ADerm-IS sleep domain score is 12.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with ADerm-IS Sleep Domain score ≥ 12 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '17.6'}, {'value': '42.6', 'groupId': 'OG001', 'lowerLimit': '29.4', 'upperLimit': '55.8'}, {'value': '64.4', 'groupId': 'OG002', 'lowerLimit': '52.2', 'upperLimit': '76.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.6', 'ciLowerLimit': '42.0', 'ciUpperLimit': '71.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.5', 'ciLowerLimit': '16.9', 'ciUpperLimit': '48.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4.\n\nThe ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with ADerm-SS Skin Pain score ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '26.7'}, {'value': '51.9', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '65.5'}, {'value': '67.3', 'groupId': 'OG002', 'lowerLimit': '54.9', 'upperLimit': '79.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.9', 'ciLowerLimit': '35.1', 'ciUpperLimit': '66.7', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.7', 'ciLowerLimit': '18.8', 'ciUpperLimit': '52.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with ADerm-SS TSS-7 ≥ 28 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '36.2'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '75.6'}, {'value': '78.7', 'groupId': 'OG002', 'lowerLimit': '67.0', 'upperLimit': '90.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.4', 'ciLowerLimit': '37.4', 'ciUpperLimit': '71.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.1', 'ciLowerLimit': '19.8', 'ciUpperLimit': '56.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS emotional state sums three items \\[Items 8-10\\] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.\n\nThe minimal clinically important difference for ADerm-IS emotional state domain score is 11.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with ADerm-IS Emotional State Domain score ≥ 11 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '44.0'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '43.4', 'upperLimit': '72.9'}, {'value': '81.4', 'groupId': 'OG002', 'lowerLimit': '69.8', 'upperLimit': '93.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.2', 'ciLowerLimit': '33.3', 'ciUpperLimit': '69.1', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.1', 'ciLowerLimit': '8.0', 'ciUpperLimit': '48.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.\n\nThe minimal clinically important difference for the ADerm-IS daily activities domain score is 14.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with ADerm-IS Daily Activities Domain Score ≥ 14 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'comment': 'Could not be calculated using the normal approximation to the binomial distribution', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '24.5'}, {'value': '31.3', 'groupId': 'OG002', 'lowerLimit': '19.9', 'upperLimit': '42.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.2', 'ciLowerLimit': '19.9', 'ciUpperLimit': '42.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '6.9', 'ciUpperLimit': '24.6', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.40', 'groupId': 'OG000', 'lowerLimit': '-35.03', 'upperLimit': '-13.78'}, {'value': '-58.28', 'groupId': 'OG001', 'lowerLimit': '-67.23', 'upperLimit': '-49.33'}, {'value': '-66.82', 'groupId': 'OG002', 'lowerLimit': '-75.57', 'upperLimit': '-58.07'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.42', 'ciLowerLimit': '-56.16', 'ciUpperLimit': '-28.68', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.88', 'ciLowerLimit': '-47.76', 'ciUpperLimit': '-19.99', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percent Change From Baseline in EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.19', 'groupId': 'OG000', 'lowerLimit': '-51.15', 'upperLimit': '-35.24'}, {'value': '-81.04', 'groupId': 'OG001', 'lowerLimit': '-87.67', 'upperLimit': '-74.41'}, {'value': '-85.03', 'groupId': 'OG002', 'lowerLimit': '-91.56', 'upperLimit': '-78.50'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.84', 'ciLowerLimit': '-52.09', 'ciUpperLimit': '-31.58', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.84', 'ciLowerLimit': '-48.17', 'ciUpperLimit': '-27.52', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '42.9'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '90.6'}, {'value': '85.9', 'groupId': 'OG002', 'lowerLimit': '77.4', 'upperLimit': '94.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.8', 'ciLowerLimit': '40.3', 'ciUpperLimit': '69.4', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.0', 'ciLowerLimit': '34.8', 'ciUpperLimit': '65.3', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with POEM score ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '56.5'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '96.3'}, {'value': '81.3', 'groupId': 'OG002', 'lowerLimit': '67.7', 'upperLimit': '94.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '21.0', 'ciUpperLimit': '69.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.6', 'ciLowerLimit': '26.7', 'ciUpperLimit': '72.5', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents who were ≥ 16 years old at Screening with DLQI score ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percent Change From Baseline in SCORAD Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.52', 'groupId': 'OG000', 'lowerLimit': '-40.95', 'upperLimit': '-24.08'}, {'value': '-65.22', 'groupId': 'OG001', 'lowerLimit': '-71.87', 'upperLimit': '-58.56'}, {'value': '-71.44', 'groupId': 'OG002', 'lowerLimit': '-77.91', 'upperLimit': '-64.97'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.92', 'ciLowerLimit': '-49.54', 'ciUpperLimit': '-28.31', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.70', 'ciLowerLimit': '-43.44', 'ciUpperLimit': '-21.96', 'estimateComment': 'Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Mixed Effect Model Repeated Measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with non-missing Baseline and Week 16 values; missing data were handled using a mixed-effect model with repeated measurements including observed measurements at all visits, except that measurements after any rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '65.1'}, {'value': '55.6', 'groupId': 'OG002', 'lowerLimit': '36.8', 'upperLimit': '74.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '51.7', 'ciLowerLimit': '31.7', 'ciUpperLimit': '71.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.7', 'ciLowerLimit': '26.7', 'ciUpperLimit': '62.8', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': 'The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}, {'type': 'SECONDARY', 'title': 'Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants received placebo orally once a day for 16 weeks.'}, {'id': 'OG001', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once daily for 16 weeks.'}, {'id': 'OG002', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once daily for 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '13.2'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '36.6'}, {'value': '30.3', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '46.0'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.1', 'ciLowerLimit': '7.3', 'ciUpperLimit': '43.0', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '34.2', 'estimateComment': 'Response Rate Difference = Upadacitinib - Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population for adolescents who were ≥ 16 years old at Screening with DLQI score ≥ 1 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adults: Placebo', 'description': 'Participants ≥ 18 years old received placebo orally once a day (QD) for 16 weeks.'}, {'id': 'FG001', 'title': 'Adults: Upadacitinib 15 mg QD', 'description': 'Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.'}, {'id': 'FG002', 'title': 'Adults: Upadacitinib 30 mg QD', 'description': 'Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.'}, {'id': 'FG003', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants (12 - 17 years old) received placebo orally once a day for 16 weeks.'}, {'id': 'FG004', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.'}, {'id': 'FG005', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized into study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '239'}, {'groupId': 'FG002', 'numSubjects': '243'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '64'}, {'groupId': 'FG005', 'numSubjects': '64'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '239'}, {'groupId': 'FG002', 'numSubjects': '243'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '64'}, {'groupId': 'FG005', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '230'}, {'groupId': 'FG002', 'numSubjects': '229'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '64'}, {'groupId': 'FG005', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Ongoing at Time of Analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 151 study sites in 24 countries across Europe, North and South America, Oceania, and the Asia-Pacific region.\n\nThe study included a 16-week double-blind treatment period followed by an ongoing blinded extension period.\n\nThe first 810 adults and adolescents enrolled constituted the Main Study; additional adolescents were enrolled in the Adolescent Substudy to ensure enrollment of a total of 180 adolescent participants overall.\n\nResults are reported up to Week 16.', 'preAssignmentDetails': 'Participants were randomized equally into 1 of 3 treatment groups, stratified by disease severity (validated Investigator Global Assessment Scale for Atopic Dermatitis \\[vIGA-AD\\] moderate \\[3\\] vs severe \\[4\\]), geographic region (US/Puerto Rico/Canada, Japan, China, and Other), and age (adolescent \\[ages 12 to 17\\] vs adult \\[ages 18 to 75\\]). Randomization for the adolescent substudy was stratified by disease severity (vIGA-AD 3 vs vIGA-AD 4) and geographic region (US/Puerto Rico/Canada vs Other).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}, {'value': '912', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Adults: Placebo', 'description': 'Participants ≥ 18 years old received placebo orally once a day for 16 weeks.'}, {'id': 'BG001', 'title': 'Adults: Upadacitinib 15 mg QD', 'description': 'Participants ≥ 18 years old received upadacitinib 15 mg orally once a day for 16 weeks.'}, {'id': 'BG002', 'title': 'Adults: Upadacitinib 30 mg QD', 'description': 'Participants ≥ 18 years old received upadacitinib 30 mg orally once a day for 16 weeks.'}, {'id': 'BG003', 'title': 'Adolescents: Placebo', 'description': 'Adolescent participants (12 - 17 years old) received placebo orally once a day for 16 weeks.'}, {'id': 'BG004', 'title': 'Adolescents: Upadacitinib 15 mg QD', 'description': 'Adolescent participants received upadacitinib 15 mg orally once a day for 16 weeks.'}, {'id': 'BG005', 'title': 'Adolescents: Upadacitinib 30 mg QD', 'description': 'Adolescent participants received upadacitinib 30 mg orally once a day for 16 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '14.44', 'groupId': 'BG000'}, {'value': '37.3', 'spread': '14.80', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '15.12', 'groupId': 'BG002'}, {'value': '15.1', 'spread': '1.70', 'groupId': 'BG003'}, {'value': '15.5', 'spread': '1.99', 'groupId': 'BG004'}, {'value': '15.7', 'spread': '1.63', 'groupId': 'BG005'}, {'value': '32.7', 'spread': '15.87', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '12 - 14 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}, {'title': '15 - 17 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '129', 'groupId': 'BG006'}]}, {'title': '18 - < 40 years', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '442', 'groupId': 'BG006'}]}, {'title': '40 - < 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '242', 'groupId': 'BG006'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '430', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '482', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '133', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '779', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '212', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '609', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Enrollment', 'classes': [{'categories': [{'title': 'Main Study', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '847', 'groupId': 'BG006'}]}, {'title': 'Adolescent Substudy', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region', 'classes': [{'categories': [{'title': 'US/Puerto Rico/Canada', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '420', 'groupId': 'BG006'}]}, {'title': 'Japan', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}, {'title': 'China', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '402', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'vIGA-AD', 'classes': [{'categories': [{'title': '3 (Moderate)', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '498', 'groupId': 'BG006'}]}, {'title': '4 (Severe)', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '414', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The vIGA-AD was used to assess the severity of AD based on lesion appearance on the following scale:\n\n* 0-Clear: No inflammatory signs of AD;\n* 1-Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2-Mild: Slight but definite erythema, induration/papulation and/or lichenification. No oozing or crusting;\n* 3-Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;\n* 4-Severe: Marked erythema, induration/papulation and/or lichenification, oozing or crusting may be present.', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) Score', 'classes': [{'categories': [{'measurements': [{'value': '28.39', 'spread': '12.082', 'groupId': 'BG000'}, {'value': '30.34', 'spread': '12.651', 'groupId': 'BG001'}, {'value': '29.06', 'spread': '11.270', 'groupId': 'BG002'}, {'value': '29.65', 'spread': '14.054', 'groupId': 'BG003'}, {'value': '30.70', 'spread': '12.816', 'groupId': 'BG004'}, {'value': '27.77', 'spread': '10.625', 'groupId': 'BG005'}, {'value': '29.28', 'spread': '12.125', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'EASI is a tool to measure the extent and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected, and the severity of eczema (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness, thickness, scratching, and lichenification are assessed. The EASI score is the sum of the scores for each region and ranges from 0 to 72, where higher scores represent worse disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Duration since Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '22.704', 'spread': '15.9393', 'groupId': 'BG000'}, {'value': '22.010', 'spread': '16.6733', 'groupId': 'BG001'}, {'value': '21.655', 'spread': '15.0471', 'groupId': 'BG002'}, {'value': '11.391', 'spread': '5.0989', 'groupId': 'BG003'}, {'value': '12.027', 'spread': '4.5017', 'groupId': 'BG004'}, {'value': '12.443', 'spread': '4.4464', 'groupId': 'BG005'}, {'value': '20.017', 'spread': '14.8779', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-28', 'size': 16767102, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-02T16:00', 'hasProtocol': True}, {'date': '2020-05-29', 'size': 854909, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-02T16:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 912}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04159597', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2018-06-14', 'resultsFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2018-06-22', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-02-02', 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.'}, {'measure': 'Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No inflammatory signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.'}], 'secondaryOutcomes': [{'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2', 'timeFrame': 'Baseline and Day 2', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).\n\nThe percentage of participants who had a 4-point or greater improvement from Baseline in Worst Pruritus NRS score at Day 2 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 30 mg group versus placebo group only.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3', 'timeFrame': 'Baseline and Day 3', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).\n\nThe percentage of participants who had a 4-point or greater improvement in Worst Pruritus NRS score from Baseline at Day 3 was pre-specified as a ranked secondary endpoint for participants in the upadacitinib 15 mg group versus placebo group only.'}, {'measure': 'Main Study: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period', 'timeFrame': 'From first dose of study drug to Week 16', 'description': 'A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flare was assessed in participants with an EASI score of 65.4 or less at Baseline.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-IS is a 10-item patient reported outcome (PRO) questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nThe ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.\n\nThe minimal clinically important difference for ADerm-IS sleep domain score is 12.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked on a daily basis to indicate how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The ADerm-SS skin pain score was analyzed using weekly rolling averages of daily scores. The minimal clinically important difference for ADerm-SS skin pain score is 4.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS 7-Item Total Symptom Score (TSS-7) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS emotional state sums three items \\[Items 8-10\\] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.\n\nThe minimal clinically important difference for ADerm-IS emotional state domain score is 11.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in in ADerm-IS Daily Activities Domain Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.\n\nThe minimal clinically important difference for the ADerm-IS daily activities domain score is 14.'}, {'measure': 'Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.'}, {'measure': 'Main Study: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.'}, {'measure': 'Main Study: Percent Change From Baseline in EASI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit."}, {'measure': 'Main Study: Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.'}, {'measure': 'Main Study: Percentage of Participants Achieving a Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score and Hospital Anxiety and Depression Scale-Depression (HADS-D) Score of < 8 at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.'}, {'measure': 'Main Study: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16', 'timeFrame': 'Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit."}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a vIGA-AD of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:\n\n* 0 - Clear: No signs of AD;\n* 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;\n* 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;\n* 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;\n* 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 90 Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 4', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 75 Response at Week 2', 'timeFrame': 'Baseline and Week 2', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 1', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Worst pruritus NRS was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 2', 'timeFrame': 'Baseline and Day 2', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Day 3', 'timeFrame': 'Baseline and Day 3', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).'}, {'measure': 'Adolescents: Percentage of Participants Experiencing a Flare During the Double-blind Treatment Period', 'timeFrame': 'From first dose of study drug to Week 16', 'description': 'A flare, characterized as a clinically meaningful worsening in EASI, is defined as an increase in EASI score of ≥ 6.6 points from Baseline during the double-blind treatment period and prior to use of any rescue medication. Flares were assessed in participants with an EASI score of 65.4 or less at Baseline.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 12 Points From Baseline in ADerm-IS Sleep Domain Score at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-IS is a 10-item patient reported outcome questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nThe ADerm-IS sleep domain consists of 3 questions designed to assess the impact of AD on sleep on a daily basis over a 24-hour recall period. The items include difficulty falling asleep, impact on sleep, and waking at night. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The ADerm-IS sleep domain score is the sum of the 3 item scores and ranges from 0 (no impact) to 30 (worst impact). The ADerm-IS sleep domain was analyzed based on weekly rolling averages of daily scores.\n\nThe minimal clinically important difference for ADerm-IS sleep domain score is 12.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in ADerm-SS Skin Pain Score at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'The ADerm-SS is an 11-item PRO questionnaire designed to assess signs and symptoms that patients may experience due to AD using a 24-hour recall period. For the skin pain item participants were asked to indicate on a daily basis how bad their worst skin pain due to AD was in the past 24 hours on an NRS from 0 (no pain) to 10 (worst imaginable pain). The minimal clinically important difference for ADerm-SS skin pain score is 4.\n\nThe ADerm-SS skin pain score was analyzed based on weekly rolling averages of daily scores.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 28 Points From Baseline in ADerm-SS TSS-7 at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-SS is an 11-item questionnaire designed to assess signs and symptoms that participants may experience due to AD using a 24-hour recall period. The 7-item total symptom score includes 7 symptoms (items 1-7 of the ADerm-SS), each assessed on a NRS from 0 (no symptom) to 10 (worst imaginable). The 7 symptoms included in the score are itch while asleep, itch while awake, skin pain (each assessed daily), skin cracking, skin cracking pain, dry skin, and skin flaking (assessed weekly). The TSS-7 score ranges from 0 to 70, with higher scores indicating worsening symptoms. The minimal clinically important difference for ADerm-SS TSS-7 is 28.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 11 Points From Baseline in ADerm-IS Emotional State Domain Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS emotional state sums three items \\[Items 8-10\\] measuring self-consciousness, embarrassment, and sadness with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The emotional state domain score ranges from 0 to 30, where higher scores represent worst impact.\n\nThe minimal clinically important difference for ADerm-IS emotional state domain score is 11.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 14 Points From Baseline in ADerm-IS Daily Activities Domain Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The ADerm-IS is a 10-item PRO questionnaire designed to assess a variety of impacts that participants experience from their AD.\n\nADerm-IS daily activities sums four items measuring limitations of household, physical, and social activities, and difficulty concentrating with a 7-day recall. Each question is scored on an 11-point NRS from 0 (no impact) to 10 (extreme impact). The daily activities domain score ranges from 0 to 40, where higher scores represent worst impact.\n\nThe minimal clinically important difference for the ADerm-IS daily activities domain score is 14.'}, {'measure': 'Adolescents: Percentage of Participants Achieving an EASI 100 Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.\n\nAn EASI 100 response is defined as a 100% reduction (improvement) from Baseline in EASI score.'}, {'measure': 'Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16', 'timeFrame': 'Baseline (last available rolling average before the first dose of study drug) and Week 16', 'description': 'Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. A negative change from Baseline indicates improvement.'}, {'measure': 'Adolescents: Percent Change From Baseline in EASI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \\[0\\], mild \\[1)\\] moderate \\[2\\], or severe \\[3\\]) for Redness (erythema, inflammation), Thickness (induration, papulation, swelling - acute eczema), Scratching (excoriation), and Lichenification (lined skin, prurigo nodules - chronic eczema).\n\nThe total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in POEM Total Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in DLQI Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit."}, {'measure': 'Adolescents: Percent Change From Baseline in SCORAD Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.'}, {'measure': 'Adolescents: Percentage of Participants Achieving HADS-A Score and HADS-D Score of < 8 at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The HADS is a 14-item questionnaire, with seven items related to anxiety (HADS-A) and seven items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each domain, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression.'}, {'measure': 'Adolescents: Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).\n\nItem scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.\n\nthe DLQI was administered to participants who were ≥ 16 (16 to 75) years old at the time of the Screening visit."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Upadacitinib'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '40900410', 'type': 'DERIVED', 'citation': 'Irvine AD, Prajapati VH, Guttman-Yassky E, Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Gold LFS, de Bruin-Weller M, Bieber T, Kabashima K, Rosmarin D, Sancho C, Calimlim BM, Grada A, Yang Y, Wu X, Levy G, Raymundo EM, Teixeira HD, Silverberg JI. Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks. Am J Clin Dermatol. 2025 Nov;26(6):1003-1016. doi: 10.1007/s40257-025-00975-3. Epub 2025 Sep 3.'}, {'pmid': '40875187', 'type': 'DERIVED', 'citation': 'Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.'}, {'pmid': '40457140', 'type': 'DERIVED', 'citation': 'Simpson EL, Silverberg JI, Prajapati VH, Eyerich K, Katoh N, Boguniewicz M, Guttman-Yassky E, Song EJ, Lee WJ, Teixeira HD, Wu T, Sancho Sanchez C, Vigna N, Calimlim BM, de Bruin-Weller M. Rapid Itch Improvement and Skin Clearance with Upadacitinib Versus Placebo (Measure Up 1 and Measure Up 2) and Versus Dupilumab (Heads Up): Results from Three Phase 3 Clinical Trials in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Aug;15(8):2061-2076. doi: 10.1007/s13555-025-01443-w. Epub 2025 Jun 2.'}, {'pmid': '39441580', 'type': 'DERIVED', 'citation': 'Paller AS, Mendes-Bastos P, Siegfried E, Eichenfield LF, Soong W, Prajapati VH, Lio P, Simpson EL, Raymundo EM, Suravaram S, Hu X, Yang Y, Huang X, Calimlim BM, Platt AM, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: Analysis of 3 Phase 3 Randomized Clinical Trials Through 76 Weeks. JAMA Dermatol. 2024 Dec 1;160(12):1304-1313. doi: 10.1001/jamadermatol.2024.3696.'}, {'pmid': '39110139', 'type': 'DERIVED', 'citation': 'Blauvelt A, Eyerich K, Irvine AD, de Bruin-Weller M, Kwatra SG, Gooderham M, Kim B, Calimlim BM, Lee WJ, Raymundo EM, Liu Y, Ofori S, Platt AM, Silverberg JI. More Time Spent with Clear Skin and No Itch with Upadacitinib versus Dupilumab for Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2621-2630. doi: 10.1007/s13555-024-01242-9. Epub 2024 Aug 7.'}, {'pmid': '38696027', 'type': 'DERIVED', 'citation': 'Simpson EL, Prajapati VH, Leshem YA, Chovatiya R, de Bruin-Weller MS, Stander S, Pink AE, Calimlim BM, Lee WJ, Teixeira H, Ladizinski B, Hu X, Yang Y, Liu Y, Liu M, Grada A, Platt AM, Silverberg JI. Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical Trials (Measure Up 1 and 2). Dermatol Ther (Heidelb). 2024 May;14(5):1127-1144. doi: 10.1007/s13555-024-01157-5. Epub 2024 May 2.'}, {'pmid': '38528257', 'type': 'DERIVED', 'citation': 'Silverberg JI, Gooderham MJ, Paller AS, Deleuran M, Bunick CG, Gold LFS, Hijnen D, Calimlim BM, Lee WJ, Teixeira HD, Hu X, Zhang S, Yang Y, Grada A, Platt AM, Thaci D. Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2). Am J Clin Dermatol. 2024 May;25(3):485-496. doi: 10.1007/s40257-024-00853-4. Epub 2024 Mar 25.'}, {'pmid': '37247226', 'type': 'DERIVED', 'citation': 'Thyssen JP, Thaci D, Bieber T, Gooderham M, de Bruin-Weller M, Soong W, Kabashima K, Barbarot S, Luna PC, Xu J, Hu X, Liu Y, Raymundo EM, Calimlim BM, Nduaka C, Gamelli A, Simpson EL. Upadacitinib for moderate-to-severe atopic dermatitis: Stratified analysis from three randomized phase 3 trials by key baseline characteristics. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1871-1880. doi: 10.1111/jdv.19232. Epub 2023 Jun 21.'}, {'pmid': '37043227', 'type': 'DERIVED', 'citation': 'Paller AS, Ladizinski B, Mendes-Bastos P, Siegfried E, Soong W, Prajapati VH, Lio P, Thyssen JP, Simpson EL, Platt AM, Raymundo EM, Liu J, Calimlim BM, Huang X, Gu Y, Hu X, Yang Y, Su JC, Zheng M, Yamamoto-Hanada K, Teixeira HD, Irvine AD. Efficacy and Safety of Upadacitinib Treatment in Adolescents With Moderate-to-Severe Atopic Dermatitis: Analysis of the Measure Up 1, Measure Up 2, and AD Up Randomized Clinical Trials. JAMA Dermatol. 2023 May 1;159(5):526-535. doi: 10.1001/jamadermatol.2023.0391.'}, {'pmid': '36754548', 'type': 'DERIVED', 'citation': 'Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.'}, {'pmid': '35714786', 'type': 'DERIVED', 'citation': 'Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.'}, {'pmid': '35262646', 'type': 'DERIVED', 'citation': 'Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.'}, {'pmid': '34023008', 'type': 'DERIVED', 'citation': 'Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaci D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.', 'detailedDescription': 'This study includes a 35-day screening period, a 16-week double-blind period, a blinded extension period up to Week 260, and a 30-day follow-up visit.\n\nParticipants who meet eligibility criteria in the main study will be randomized in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg or upadacitinib 15 mg or matching placebo. Upon completion of enrollment of 810 participants in the main study, a supplemental study will continue to enroll adolescents (adolescent sub-study) until a total of 180 adolescent participants are enrolled in the overall study (main study + adolescent sub-study).\n\nRandomization for the main study will be stratified by baseline disease severity (validated Investigator Global Assessment scale for Atopic Dermatitis \\[vIGA-AD\\] score of moderate \\[3\\] versus severe \\[4\\]), by geographic region (United States \\[US\\]/Puerto Rico/Canada, Japan, China, and Other), and by age (adolescent \\[ages 12 to 17\\] versus adult \\[ages 18 to 75\\]). The separate randomization for the adolescent sub-study will be stratified by baseline disease severity (moderate \\[vIGA-AD 3\\] vs. severe \\[vIGA-AD 4\\]) and by geographic region (US/Puerto Rico/Canada and Other).\n\nAt Week 16 of the main study and the adolescent sub-study, participants in the placebo group will be re-randomized in a 1:1 ratio to receive daily oral doses of upadacitinib 30 mg or upadacitinib 15 mg in the blinded extension period. In the main study the re-randomization at Week 16 will be stratified by Week 16 50% improvement in Eczema Area and Severity Index \\[EASI 50\\] responder \\[yes/no\\], geographic region \\[US/Puerto Rico/Canada, China \\[Mainland\\], Japan, and other\\], and age group \\[adolescent/adult\\]. For the adolescent sub-study, the re-randomization will be stratified by EASI 50 responder (Yes/No) and by geographic region (US/Puerto Rico/Canada and Other).\n\nParticipants originally randomized to upadacitinib will continue upadacitinib in the extension period at the same dose.\n\nStarting at the Week 4 visit, rescue treatment for AD may be provided at the discretion of the investigator if medically necessary.\n\nThe Primary Analysis for the main study will be conducted after all ongoing participants have completed Week 16. In addition, a Primary Analysis for the adolescent population (including the adolescent participants from the main study and the adolescent sub-study) will be conducted after all ongoing adolescent participants have completed Week 16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and \\< 18 years of age\n* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.\n* Active moderate to severe AD defined by:\n\n * Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;\n * Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;\n * ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;\n * Baseline weekly average of daily Worst Pruritus NRS ≥ 4.\n* Candidate for systemic therapy or have recently required systemic therapy for AD\n* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.\n* Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit\n\nExclusion Criteria:\n\n* Prior exposure to any Janus kinase (JAK) inhibitor\n* Unable or unwilling to discontinue current atopic dermatitis treatments prior to the study\n* Requirement of prohibited medications during the study\n* Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions\n* Female subject who is pregnant, breastfeeding, or considering pregnancy during the study"}, 'identificationModule': {'nctId': 'NCT03569293', 'acronym': 'Measure Up 1', 'briefTitle': 'Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'M16-045'}, 'secondaryIdInfos': [{'id': '2022-502938-30-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo / Upadacitinib', 'description': 'Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.', 'interventionNames': ['Drug: Placebo for Upadacitinib', 'Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Upadacitinib 15 mg QD', 'description': 'Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.', 'interventionNames': ['Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Upadacitinib 30 mg QD', 'description': 'Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.', 'interventionNames': ['Drug: Upadacitinib']}], 'interventions': [{'name': 'Placebo for Upadacitinib', 'type': 'DRUG', 'description': 'Tablets taken orally once a day', 'armGroupLabels': ['Placebo / Upadacitinib']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'otherNames': ['ABT-494', 'RINVOQ™'], 'description': 'Tablets taken orally once a day', 'armGroupLabels': ['Placebo / Upadacitinib', 'Upadacitinib 15 mg QD', 'Upadacitinib 30 mg QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance Dermatology and MOHs /ID# 200375', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85255-4134', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clear Dermatology & Aesthetics Center /ID# 201256', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Bakersfield Derma & Skin Cance /ID# 200433', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92708-3701', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'First OC Dermatology /ID# 201910', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90025-7014', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Allergy and Asthma Medical Group /ID# 200727', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691-6410', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Asthma Associates of Southern California /ID# 200733', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92660-7853', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Clinical Trials /ID# 205876', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis /ID# 203622', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94132-1909', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Dermatology /ID# 200842', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93405', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'San Luis Derm and Laser Clinic /ID# 200372', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University /ID# 200440', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '94598-2488', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Care Access Research - 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}