BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Trial end date: 2018-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Boehringer Ingelheim
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.

• Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):

1. Have an involved body surface area (BSA) ≥10% and

2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and

3. Have a Static Physician Global Assessment (sPGA) score of ≥3.

Exclusion Criteria:

• Patients with

1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)

2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment

• Previous exposure to BI 655066