Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-06 @ 1:34 PM
Study NCT ID:
NCT02489227
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2015-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
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Finck, MD', 'organization': 'Coherus BioSciences, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment Period 1: CHS-1420', 'description': 'CHS-1420 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15', 'otherNumAtRisk': 274, 'deathsNumAtRisk': 274, 'otherNumAffected': 41, 'seriousNumAtRisk': 274, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Treatment Period 1: Humira (Adalimumab)', 'description': 'Adalimumab (Humira) 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 38, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Treatment Period 2: CHS-1420/CHS-1420', 'description': 'At week 16 subjects initially randomized to CHS-1420 will continue CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24', 'otherNumAtRisk': 255, 'deathsNumAtRisk': 255, 'otherNumAffected': 0, 'seriousNumAtRisk': 255, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Treatment Period 2: Humira/CHS-1420', 'description': 'At Week 16 subjects initially randomized to Humira (adalimumab) will be reassigned to CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Teatment Period 2: Humira/Humira', 'description': 'At Week 16 subjects initially randomized to Humira (adalimumab) will continue adalimumab treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Treatment Period 3: Open Label CHS-1420 Extension', 'description': 'At week 24 all subjects will switch to CHS-1420 treatment 40 mg, 1 dose every 2 weeks, open label, starting at week 24 until study end', 'otherNumAtRisk': 474, 'deathsNumAtRisk': 474, 'otherNumAffected': 0, 'seriousNumAtRisk': 474, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Chronic and obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Congenital Cystic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 255, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira (Adalimumab)', 'description': 'Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420 open label until study end.\n\nCHS-1420\n\nAdalimumab'}, {'id': 'OG001', 'title': 'CHS-1420', 'description': 'CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.\n\nCHS-1420'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHS-1420', 'description': 'CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.\n\nCHS-1420'}, {'id': 'FG001', 'title': 'Humira (Adalimumab) Reassigned to CHS-1420', 'description': 'Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.open label until study end.\n\nAdalimumab\n\nCHS-1420'}, {'id': 'FG002', 'title': 'Humira (Adalimumab)', 'description': 'Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end..\n\nAdalimumab\n\nCHS-1420'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '545', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CHS-1420', 'description': 'CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.\n\nCHS-1420'}, {'id': 'BG001', 'title': 'Humira (Adalimumab) Reassigned to CHS-1420', 'description': 'Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.\n\nAdalimumab\n\nCHS-1420'}, {'id': 'BG002', 'title': 'Humira (Adalimumab)', 'description': 'Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.\n\nAdalimumab\n\nCHS-1420'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '507', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '394', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-16', 'size': 2280392, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-26T13:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2017-05-31', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2015-07-01', 'dispFirstSubmitQcDate': '2017-06-09', 'resultsFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2015-07-01', 'dispFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-26', 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12', 'timeFrame': '12 weeks', 'description': 'The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PsO'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.', 'detailedDescription': 'This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO.\n\nThe study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female adults\n* PsO diagnosis for 6 months\n* Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5),\n* Body Surface Area (BSA) involved with PsO greater than or equal to 10%\n\nExclusion Criteria:\n\n* Forms of psoriasis other than PsO\n* Drug induced psoriasis\n* Positive QuantiFERON-tuberculosis (TB) Gold Test\n* Presence of significant comorbid conditions\n* Chemistry and hematology values outside protocol specified range\n* Major systemic infections"}, 'identificationModule': {'nctId': 'NCT02489227', 'acronym': 'PsOsim', 'briefTitle': 'Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coherus Oncology, Inc.'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'CHS-1420-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Humira (adalimumab)', 'description': 'Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be assigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. The assignments for treatment sequences (Treatment Period 1 and Treatment Period 2) were made randomly at the beginning of Treatment Period 1. At week 24 subjects will switch to CHS-1420 open label until study end.', 'interventionNames': ['Drug: CHS-1420', 'Drug: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'CHS-1420', 'description': 'CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.', 'interventionNames': ['Drug: CHS-1420']}], 'interventions': [{'name': 'CHS-1420', 'type': 'DRUG', 'armGroupLabels': ['CHS-1420', 'Humira (adalimumab)']}, {'name': 'Adalimumab', 'type': 'DRUG', 'otherNames': ['Humira'], 'armGroupLabels': ['Humira (adalimumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sadra Sasha Jazayeri, MD', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Encino Research Center', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology and Laser Surgery', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 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