A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Methotrexate

Criteria

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