A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2020-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.

• Participant meets following disease activity criteria:

• Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.

• Candidate for systemic therapy as assessed by the investigator.

Exclusion Criteria:

• Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.

• Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.

• Participant has previous exposure to risankizumab.