BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Sponsor
AbbVie
Study ID
NCT02684357
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Key Dates

Start date
Mar 31, 2016
Status verified
Jul 2021
Primary completion
Dec 31, 2016
Completion
Sep 30, 2017

Study Design

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

Arms

  • Placebo Comparator: Placebo (Part A)
    Participants were randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
  • Active Comparator: Ustekinumab (Part A)
    Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
  • Experimental: Risankizumab (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 in Participants Who Received Risankizumab Compared With Placebo (Part A) [ Time Frame: Week 16 ]

Related Studies