Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-29 @ 3:48 AM
Study NCT ID:
NCT03822832
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}}}, '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': 'C000712973', 'term': 'spesolimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44).', 'description': 'Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.\n\nOpen label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Week 1-16) and if no Treatment, Week 16-28', 'description': 'Placebo intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\\<75 were classified as nonresponders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 10, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Spesolimab (Week 1-16) and no Treatment (Week 16-28)', 'description': '600mg Spesolimab (BI 655130) intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\\<75 were classified as non-responders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 16, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Spesolimab (Open Label Period, Week 16-44)', 'description': 'Following the double blind period (week 0 to 16) patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI\\<75 were classified as nonresponders and were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28), end of study is at week 44.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Beta haemolytic streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cold urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis exfoliative generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.3', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '-37.9', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1492', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-25.6', 'ciLowerLimit': '-54.9', 'ciUpperLimit': '3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.4', 'estimateComment': 'Difference calculated as Spesolimab - Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'See endpoint description for model description.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.\n\nRestricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Drug Related Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'title': 'Double blind treatment period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Re-allocation treatment period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 weeks, see endpoint description for more details.', 'description': 'Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.\n\nDouble blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.\n\nRe-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.\n\nRe-allocation treatment period: This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '7.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.8', 'estimateComment': 'Difference calculated as Spesolimab - Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'See endpoint description for model description.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.', 'description': 'Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.\n\nRestricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Change in score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.6', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '-23.8', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.2', 'ciLowerLimit': '-25.8', 'ciUpperLimit': '21.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.0', 'estimateComment': 'Difference calculated as Spesolimab - Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'See endpoint description for model description.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.', 'description': 'Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.\n\nRestricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.333', 'groupId': 'OG000'}, {'value': '0.303', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.056', 'groupId': 'OG000'}, {'value': '0.303', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.030', 'ciLowerLimit': '-0.254', 'ciUpperLimit': '0.176', 'estimateComment': 'Difference calculated as Spesolimab - Placebo', 'groupDescription': 'Risk difference at week 4', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CIs are calculated using the method of Wilson and Newcombe.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.247', 'ciLowerLimit': '0.053', 'ciUpperLimit': '0.396', 'estimateComment': 'Difference calculated as Spesolimab - Placebo', 'groupDescription': 'Risk difference at week 16', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CIs are calculated using the method of Wilson and Newcombe.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.', 'unitOfMeasure': 'Proportion of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.111', 'groupId': 'OG000'}, {'value': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.056', 'groupId': 'OG000'}, {'value': '0.152', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.020', 'ciLowerLimit': '-0.204', 'ciUpperLimit': '0.117', 'estimateComment': 'Difference calculated as Spesolimab - Placebo', 'groupDescription': 'Risk difference at week 4', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CIs are calculated using the method of Wilson and Newcombe.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.096', 'ciLowerLimit': '-0.080', 'ciUpperLimit': '0.232', 'estimateComment': 'Difference calculated as Spesolimab - Pl', 'groupDescription': 'Risk difference at week 16', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CIs are calculated using the method of Wilson and Newcombe.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.', 'unitOfMeasure': 'Proportion of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.3', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9900', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-14.6', 'ciUpperLimit': '14.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.7', 'estimateComment': 'Difference calculated as Spesolimab - Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'See endpoint description for model description.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.', 'description': "SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.\n\nREML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.", 'unitOfMeasure': 'Change in score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '-25.5', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-14.9', 'ciLowerLimit': '-35.2', 'ciUpperLimit': '5.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.1', 'estimateComment': 'Difference calculated as Spesolimab - Placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'See endpoint description for model description.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': "SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.\n\nREML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.", 'unitOfMeasure': 'Change in score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}, {'type': 'SECONDARY', 'title': "Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'OG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.005', 'ciLowerLimit': '-0.159', 'ciUpperLimit': '0.120', 'estimateComment': 'Difference calculated as Spesolimab - Placebo', 'groupDescription': 'Risk difference at week 4', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CIs are calculated using the method of Wilson and Newcombe.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.091', 'ciLowerLimit': '-0.050', 'ciUpperLimit': '0.207', 'estimateComment': 'Difference calculated as Spesolimab - Placebo', 'groupDescription': 'Risk difference at week 16', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'CIs are calculated using the method of Wilson and Newcombe.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator\'s Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: "None", "Barely Perceptible" ("Minimal" for lichenification), "Slight but Definite", "Clearly Perceptible" or "Marked". For oozing/crusting the available answers are "None" or "Present."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'FG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}], 'periods': [{'title': 'Period 1 - Double Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Re-allocation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'comment': 'Patient re-allocated to open label Spesolimab treatment', 'achievements': [{'comment': 'Patient re-allocated to open label Spesolimab treatment', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'Patient re-allocated to open label Spesolimab treatment', 'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Not re-allocated to open label period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Period 2 - Open Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patient re-allocated to open label Spesolimab treatment', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'Patient re-allocated to open label Spesolimab treatment', 'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This was a phase IIa multicentre, randomized, double-blind, placebocontrolled, study to evaluate the safety, tolerability and efficacy of treatment with BI 655130 in adult patients with moderate to severe atopic dermatitis.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Intravenous Every 4 Weeks', 'description': 'Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'BG001', 'title': 'Spesolimab 600 mg Intravenous Every 4 Weeks', 'description': '600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '15.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI) Score', 'classes': [{'categories': [{'measurements': [{'value': '26.43', 'spread': '8.60', 'groupId': 'BG000'}, {'value': '26.53', 'spread': '10.07', 'groupId': 'BG001'}, {'value': '26.50', 'spread': '9.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Eczema Area and Severity Index (EASI) Score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SCORing of Atopic Dermatitis (SCORAD)', 'classes': [{'categories': [{'measurements': [{'value': '62.82', 'spread': '14.13', 'groupId': 'BG000'}, {'value': '60.09', 'spread': '10.36', 'groupId': 'BG001'}, {'value': '61.06', 'spread': '11.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to A (0-100). Intensity (B): intensity of each sign was assessed from none=0 to severe=3. Scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored using visual analogue scale from 0 to 10, higher scores=worse. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Investigator's Global Assessment (IGA) score", 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Investigator\'s Global Assessment (IGA) score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: "None", "Barely Perceptible" ("Minimal" for lichenification), "Slight but Definite", "Clearly Perceptible" or "Marked". For oozing/crusting the available answers are "None" or "Present."', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized set (RS): this patient set includes all patients who were randomized into the trial. It will be used for display of patient disposition, baseline and demographic characteristics, and patients with IPDs (Important Protocol Deviations).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-12', 'size': 738326, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-30T10:09', 'hasProtocol': True}, {'date': '2020-08-20', 'size': 378603, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-30T10:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2020-12-16', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2019-01-28', 'dispFirstSubmitQcDate': '2022-11-15', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2019-01-29', 'dispFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-11-15', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.\n\nRestricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Drug Related Adverse Events (AEs)', 'timeFrame': 'Up to 28 weeks, see endpoint description for more details.', 'description': 'Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period.\n\nDouble blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks.\n\nRe-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.'}, {'measure': 'Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4', 'timeFrame': 'Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.', 'description': 'Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.\n\nRestricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.'}, {'measure': 'Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4', 'timeFrame': 'Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.', 'description': 'Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.\n\nRestricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.'}, {'measure': 'Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.'}, {'measure': 'Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.'}, {'measure': 'Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4', 'timeFrame': 'Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.', 'description': "SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.\n\nREML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used."}, {'measure': 'Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16', 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': "SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.\n\nREML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used."}, {'measure': "Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16", 'timeFrame': 'Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.', 'description': 'Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator\'s Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: "None", "Barely Perceptible" ("Minimal" for lichenification), "Slight but Definite", "Clearly Perceptible" or "Marked". For oozing/crusting the available answers are "None" or "Present."'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '39216969', 'type': 'DERIVED', 'citation': "Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available."}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to investigate the safety, tolerability and efficacy of BI 655130 in patients with Atopic Dermatitis (AD) following repeated intravenous administrations compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures\n* Male or female patients, 18 to 75 years of age at screening\n* Diagnosis of atopic dermatitis for at least 1 year\n* Moderate to severe atopic dermatitis defined as:\n\n * At least 10% Body Surface Area (BSA) of atopic dermatitis involvement at screening and baseline\n * Eczema Area and Severity Index (EASI) of at least 12 at screening and at least 16 at baseline\n * Investigator Global Assessment (IGA) of at least 3 at screening and baseline\n* Documented history of inadequate response to topical corticosteroid as judged by the investigator\n* Willing to use a standard emollient for the duration of the study\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.\n\nExclusion Criteria:\n\n* Use of topical corticosteroids or other agents for atopic dermatitis within 7 days prior to first dose of trial treatment.\n* Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating; they should refrain from breastfeeding up to 16 weeks after the last study drug administration\n* Patient with a transplanted organ (with exception of a corneal transplant \\> 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Prochymal).\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.\n* Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.\n* History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.\n* Active systemic infections (Fungal and bacterial disease) during the last 2 weeks prior to first drug administration, per investigator assessment.\n* Relevant chronic or acute infections (exception: common cold) including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.\n* Active or Latent Tuberculosis (TB):\n\n * Patients with active tuberculosis are excluded.\n * Patients with a positive QuantiFERON TB test during screening are excluded, unless:\n\n * Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practice/guidelines within the last 3 years and at least 6 months before first administration of trial medication under this protocol (patients may be re-screened once to meet this criterion)\n * Patients with suspected false positive or indeterminate QuantiFERON TB result may be re-tested once\n * If the QuantiFERON TB test result is not available or provides indeterminate results after repeat testing: A tuberculin skin test reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent) is considered positive.\n* Currently enrolled in another investigational device or drug trial, or less than 30 days or 5 half lives, whichever is longer since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).\n* Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than AD, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data.\n* Major surgery (major according to the investigator) performed within 12 weeks prior to first study drug adminstration or planned during the study (e.g. hip replacement, aneurysm removal, stomach ligation).\n* Severe, progressive, or uncontrolled hepatic disease, defined as \\>3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or \\>2-fold ULN elevation in total bilirubin.'}, 'identificationModule': {'nctId': 'NCT03822832', 'briefTitle': 'A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Phase IIa, Multicentre, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Treatment With BI 655130 in Adult Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': '1368-0032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spesolimab', 'description': 'i.v.', 'interventionNames': ['Drug: BI 655130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'i.v.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BI 655130', 'type': 'DRUG', 'otherNames': ['Spesolimab'], 'description': 'Solution for infusion', 'armGroupLabels': ['Spesolimab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Dermatology and Plastic Surgery', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Physiology Associates', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Finlay Medical Research Corp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'ForCare Clinical Research, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Clinical Trials Center, PC', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '73118', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Unity Clinical Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Treatment and Research Center, PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital (University of Alberta)', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'A1C 2H5', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'NewLab Clinical Research Inc.', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'H2X 2V1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Innovaderm Research Inc.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '480-1195', 'city': 'Aichi, Nagakute', 'country': 'Japan', 'facility': 'Aichi Medical University Hospital'}, {'zip': '810-8563', 'city': 'Fukuoka, Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Medical Center'}, {'zip': '830-0011', 'city': 'Fukuoka, Kurume', 'country': 'Japan', 'facility': 'Kurume University Hospital'}, {'zip': '064-0807', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Hosui General Medical Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '240-0004', 'city': 'Kanagawa, Yokohama', 'country': 'Japan', 'facility': 'Tennocho Ekimae Dermatology and Allergology'}, {'zip': '602-8566', 'city': 'Kyoto, Kyoto', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine'}, {'zip': '852-8501', 'city': 'Nagasaki, Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital'}, {'zip': '545- 8586', 'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': 'Osaka City University Hospital'}, {'zip': '193-0998', 'city': 'Tokyo, Hachioji', 'country': 'Japan', 'facility': 'Tokyo Medical University Hachioji Medical Center'}, {'zip': '142-8666', 'city': 'Tokyo, Shinagawa-ku', 'country': 'Japan', 'facility': 'Showa University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}