A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

M16-177

The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.

2018-07-30

2021-11-26

2021-11-26

Completed

Early phase I

104

Inclusion Criteria: * Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug * Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits * Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator * Be a candidate for treatment with methotrexate (MTX) according to local label Exclusion Criteria: * Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment * Previous exposure to risankizumab * Previous exposure to MTX * Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator * Subject has a history of clinically significant hematologic, renal, or liver disease

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

2022-11-03