Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT03533751
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2018-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@anaptysbio.com', 'phone': '858-362-6295', 'title': 'Clinical Project Leader', 'organization': 'AnaptysBio, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to Week 24', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 24, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 22, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 23, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 18, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 26, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'seriousEvents': [{'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Troponin I Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Joint Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Dermatitis Exfoliative Generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Eczema Herpeticum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.38', 'spread': '7.124', 'groupId': 'OG000'}, {'value': '-41.63', 'spread': '6.707', 'groupId': 'OG001'}, {'value': '-55.70', 'spread': '6.206', 'groupId': 'OG002'}, {'value': '-47.40', 'spread': '6.091', 'groupId': 'OG003'}, {'value': '-44.56', 'spread': '7.811', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.75', 'ciLowerLimit': '-12.4066', 'ciUpperLimit': '27.8983', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.235', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value was obtained using a mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and Baseline EASI as covariate.'}, {'pValue': '0.5010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.32', 'ciLowerLimit': '-24.7740', 'ciUpperLimit': '12.1262', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.390', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.'}, {'pValue': '0.8349', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-16.6037', 'ciUpperLimit': '20.5476', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.454', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.'}, {'pValue': '0.6662', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.82', 'ciLowerLimit': '-17.1892', 'ciUpperLimit': '26.8275', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.154', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Missing data were imputed using multiple imputation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.4200', 'ciUpperLimit': '1.9509', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.2197', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.7570', 'ciUpperLimit': '3.3572', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.7197', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.5345', 'ciUpperLimit': '2.4774', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.6772', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.3910', 'ciUpperLimit': '1.8404', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.9537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.3922', 'ciUpperLimit': '2.6994', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.3316', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '0.6323', 'ciUpperLimit': '3.8895', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.5166', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.5331', 'ciUpperLimit': '3.4944', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.7426', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.4545', 'ciUpperLimit': '3.0223', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '0.3998', 'ciUpperLimit': '7.7615', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.1874', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.57', 'ciLowerLimit': '0.6314', 'ciUpperLimit': '10.4827', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.1721', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.69', 'ciLowerLimit': '0.6506', 'ciUpperLimit': '11.0814', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}, {'pValue': '0.6755', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.1086', 'ciUpperLimit': '4.2141', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.6058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.2481', 'ciUpperLimit': '2.2543', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.'}, {'pValue': '0.9521', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.3356', 'ciUpperLimit': '2.7923', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.'}, {'pValue': '0.6905', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.4457', 'ciUpperLimit': '3.3878', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.'}, {'pValue': '0.9399', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.3671', 'ciUpperLimit': '2.9518', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a static 5-point scale to evaluate AD severity globally:\n\n0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present\n\n1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting\n2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting\n3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present\n4. Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present.\n\nNumber of participants with ≥2 points reduction in vIGA-AD is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7659', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.3290', 'ciUpperLimit': '4.5268', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as covariate.'}, {'pValue': '0.6273', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.3895', 'ciUpperLimit': '4.7760', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.'}, {'pValue': '0.2967', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.5734', 'ciUpperLimit': '6.1879', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.'}, {'pValue': '0.5544', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '0.4152', 'ciUpperLimit': '5.1476', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'vIGA-AD is static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present\n\n1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting\n2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting\n3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present\n4. Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread. Oozing or crusting may be present Participants who achieved vIGA-AD response of 0 (clear) or 1 (almost clear) are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.3175', 'ciUpperLimit': '3.9513', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.'}, {'pValue': '0.3222', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '0.5511', 'ciUpperLimit': '6.1214', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.'}, {'pValue': '0.2564', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '0.6089', 'ciUpperLimit': '6.4310', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.'}, {'pValue': '0.2912', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.89', 'ciLowerLimit': '0.5806', 'ciUpperLimit': '6.1275', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.13', 'spread': '5.964', 'groupId': 'OG000'}, {'value': '-22.30', 'spread': '6.211', 'groupId': 'OG001'}, {'value': '-17.69', 'spread': '6.530', 'groupId': 'OG002'}, {'value': '-30.39', 'spread': '6.176', 'groupId': 'OG003'}, {'value': '-27.18', 'spread': '6.192', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8927', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-18.2117', 'ciUpperLimit': '15.8686', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.679', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.'}, {'pValue': '0.7035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.43', 'ciLowerLimit': '-14.2767', 'ciUpperLimit': '21.1463', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.019', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.'}, {'pValue': '0.2819', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.27', 'ciLowerLimit': '-26.1590', 'ciUpperLimit': '7.6237', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.608', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.'}, {'pValue': '0.4793', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.06', 'ciLowerLimit': '-22.8452', 'ciUpperLimit': '10.7333', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.557', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.99', 'spread': '4.764', 'groupId': 'OG000'}, {'value': '-31.42', 'spread': '4.605', 'groupId': 'OG001'}, {'value': '-39.22', 'spread': '4.294', 'groupId': 'OG002'}, {'value': '-35.48', 'spread': '4.401', 'groupId': 'OG003'}, {'value': '-31.23', 'spread': '4.927', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.3262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.57', 'ciLowerLimit': '-6.5723', 'ciUpperLimit': '19.7054', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.677', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.'}, {'pValue': '0.8465', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.23', 'ciLowerLimit': '-13.7439', 'ciUpperLimit': '11.2782', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.366', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.'}, {'pValue': '0.6947', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '-10.0587', 'ciUpperLimit': '15.0820', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.396', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.'}, {'pValue': '0.3288', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.76', 'ciLowerLimit': '-6.8451', 'ciUpperLimit': '20.3626', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.909', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.'}], '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 extent of disease (0 \\[no disease\\]-102 \\[worst disease\\]). 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 (none) to 18 (severe intensity). Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (itch: 0 \\[no itch\\] to 10 \\[worst imaginable itch\\] and sleeplessness: 0 \\[no sleeplessness\\] to 10 \\[worst imaginable sleeplessness\\]) (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 (no AD present) to 103.4 (worst).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Missing data were imputed using multiple imputation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.61', 'spread': '0.946', 'groupId': 'OG000'}, {'value': '-5.35', 'spread': '0.966', 'groupId': 'OG001'}, {'value': '-6.52', 'spread': '0.945', 'groupId': 'OG002'}, {'value': '-6.05', 'spread': '0.945', 'groupId': 'OG003'}, {'value': '-5.18', 'spread': '1.036', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8497', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-2.4081', 'ciUpperLimit': '2.9218', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.355', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.'}, {'pValue': '0.5016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-3.5636', 'ciUpperLimit': '1.7473', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.350', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.'}, {'pValue': '0.7511', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-3.1670', 'ciUpperLimit': '2.2870', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.386', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.'}, {'pValue': '0.7558', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-2.3133', 'ciUpperLimit': '3.1824', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.396', 'estimateComment': 'Difference = Etokimab - Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', '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). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'OG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'OG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'OG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to Week 24', 'description': 'An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent adverse event (TEAE) is any AE that started or worsened in severity on or after the date and time of the study drug administration. A serious adverse event (SAE) is as any untoward medical occurrence that, at any dose:\n\n* Resulted in death;\n* Was life-threatening;\n* Required inpatient hospitalization or prolongation of existing hospitalization;\n* Resulted in persistent disability/incapacity;\n* Was a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.'}, {'id': 'FG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.'}, {'id': 'FG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'FG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'FG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Use of any excluded/prohibited medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This study was conducted at 75 centers in the United States, United Kingdom, Canada, Czech Republic, Germany, and Poland. The study enrolled adults with moderate to severe atopic dermatitis (AD).\n\nThe study included a treatment period of 16 weeks (Week 0 to 16) followed by a safety follow-up for 8 weeks (Week 16 to Week 24).', 'preAssignmentDetails': 'Participants were equally randomized on Day 1 to one of five treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks.'}, {'id': 'BG001', 'title': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.'}, {'id': 'BG002', 'title': 'Etokimab 300 mg / 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.'}, {'id': 'BG003', 'title': 'Etokimab 300 mg / 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'BG004', 'title': 'Etokimab 600 mg / 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '39.5', 'spread': '15.92', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '16.76', 'groupId': 'BG001'}, {'value': '39.7', 'spread': '14.38', 'groupId': 'BG002'}, {'value': '38.9', 'spread': '14.61', 'groupId': 'BG003'}, {'value': '37.1', 'spread': '14.78', 'groupId': 'BG004'}, {'value': '39.0', 'spread': '15.28', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '146', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '154', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '253', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '243', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eczema Area and Severity Index (EASI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '299', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '11.45', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '12.08', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '10.38', 'groupId': 'BG002'}, {'value': '32.2', 'spread': '13.06', 'groupId': 'BG003'}, {'value': '29.5', 'spread': '12.19', 'groupId': 'BG004'}, {'value': '29.1', 'spread': '11.92', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included.'}, {'title': 'Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Grade 0 (Clear)', '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'}]}, {'title': 'Grade 1 (Almost clear)', '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'}]}, {'title': 'Grade 2 (Mild)', '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'}]}, {'title': 'Grade 3 (Moderate)', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}]}, {'title': 'Grade 4 (Severe)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The vIGA-AD is a 5-point scale to evaluate AD severity:\n\n* 0: Clear - No inflammatory signs of AD (erythema, induration/papulation, lichenification, oozing/crusting);\n* 1: Almost clear - Barely perceptible erythema, induration/papulation, minimal lichenification;\n* 2: Mild - Slight but definite erythema, induration/papulation, or lichenification. No oozing/crusting;\n* 3: Moderate - Clearly perceptible erythema, induration/papulation, or lichenification. Oozing or crusting may be present;\n* 4: Severe - Marked erythema, induration/papulation, or lichenification. Oozing or crusting may be present.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-02', 'size': 2551080, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-29T03:46', 'hasProtocol': True}, {'date': '2019-10-24', 'size': 1748380, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-29T03:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2018-04-27', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-26', 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).'}, {'measure': 'Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).'}, {'measure': 'Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \\[0\\], mild \\[1\\], moderate \\[2\\], or severe \\[3\\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).'}, {'measure': "Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16", 'timeFrame': 'Baseline and Week 16', 'description': 'The vIGA-AD is a static 5-point scale to evaluate AD severity globally:\n\n0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present\n\n1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting\n2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting\n3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present\n4. Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present.\n\nNumber of participants with ≥2 points reduction in vIGA-AD is presented.'}, {'measure': 'Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16', 'timeFrame': 'Week 16', 'description': 'vIGA-AD is static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present\n\n1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting\n2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting\n3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present\n4. Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread. Oozing or crusting may be present Participants who achieved vIGA-AD response of 0 (clear) or 1 (almost clear) are reported.'}, {'measure': 'Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.'}, {'measure': 'Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.'}, {'measure': '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 extent of disease (0 \\[no disease\\]-102 \\[worst disease\\]). 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 (none) to 18 (severe intensity). Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (itch: 0 \\[no itch\\] to 10 \\[worst imaginable itch\\] and sleeplessness: 0 \\[no sleeplessness\\] to 10 \\[worst imaginable sleeplessness\\]) (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 (no AD present) to 103.4 (worst).'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (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). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement."}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'From first dose to Week 24', 'description': 'An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent adverse event (TEAE) is any AE that started or worsened in severity on or after the date and time of the study drug administration. A serious adverse event (SAE) is as any untoward medical occurrence that, at any dose:\n\n* Resulted in death;\n* Was life-threatening;\n* Required inpatient hospitalization or prolongation of existing hospitalization;\n* Resulted in persistent disability/incapacity;\n* Was a congenital anomaly/birth defect.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ANB020', 'etokimab', 'eczema', 'moderate to severe'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.anaptysbio.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of etokimab in adult participants with atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female participants must be 18 to 75 years of age, at the time of signing the informed consent.\n2. Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m\\^2) at screening.\n3. Clinically confirmed diagnosis of AD.\n4. Eczema Area and Severity Index (EASI) score ≥ 16, body surface area (BSA) involvement ≥ 10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥ 3 at baseline.\n5. Participants with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable.\n6. Daily use of non-medicated emollient for at least 7 days prior to baseline.\n\nExclusion Criteria:\n\n1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.\n2. Prior exposure to an anti-interleukin (IL)-33 antibody.\n3. Exposure to an investigational or licensed or other anti T-helper 2 (Th2) type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.\n4. History of prior exposure to any investigational or biologic systemic treatment within 5 half lives of the screening or is currently enrolled in another clinical study.\n5. Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.\n6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03533751', 'acronym': 'ATLAS', 'briefTitle': 'Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AnaptysBio, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ANB020-005'}, 'secondaryIdInfos': [{'id': '2018-000331-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Etokimab 20 mg SC Q4W', 'description': 'Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.', 'interventionNames': ['Biological: Etokimab']}, {'type': 'EXPERIMENTAL', 'label': 'Etokimab 300 mg load + 150 mg SC Q8W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.', 'interventionNames': ['Biological: Etokimab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Etokimab 300 mg load + 150 mg SC Q4W', 'description': 'Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.', 'interventionNames': ['Biological: Etokimab']}, {'type': 'EXPERIMENTAL', 'label': 'Etokimab 600 mg load + 300 mg SC Q4W', 'description': 'Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.', 'interventionNames': ['Biological: Etokimab']}], 'interventions': [{'name': 'Etokimab', 'type': 'BIOLOGICAL', 'otherNames': ['ANB020'], 'description': 'Humanized monoclonal antibody, administered by subcutaneous injection', 'armGroupLabels': ['Etokimab 20 mg SC Q4W', 'Etokimab 300 mg load + 150 mg SC Q4W', 'Etokimab 300 mg load + 150 mg SC Q8W', 'Etokimab 600 mg load + 300 mg SC Q4W']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Etokimab 300 mg load + 150 mg SC Q8W', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Applied Research Center of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Encino Research Group', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Irvine Center for Clinical Research, Inc.', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 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