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

Sponsor
AbbVie
Study ID
NCT03000075
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • risankizumab — DRUG
    Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
  • placebo for risankizumab — DRUG
    Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

Study Details

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).

Key Dates

Start date
Dec 2, 2016
Status verified
May 2019
Primary completion
Sep 21, 2017
Completion
Jun 20, 2018

Study Design

Enrollment
182 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo (Part A)
    Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
  • Experimental: Risankizumab 75 mg (Part A)
    Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
  • Experimental: Risankizumab 150 mg (Part A)
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Primary Outcome Measure

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) [ Time Frame: Week 16 ]

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