A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Trial end date: 2020-08-25
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI 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 ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 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