BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

Sponsor
AbbVie
Study ID
NCT02694523
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab 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
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

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

Arms

  • Active Comparator: Adalimumab (Part A)
    Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
  • Experimental: Risankizumab (Part A)
    Participants randomized to receive risankizumab 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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