BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Sponsor
AbbVie
Study ID
NCT02672852
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 injection
  • Placebo — DRUG
    Placebo for risankizumab administered by subcutaneous injection

Study Details

This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.

Key Dates

Start date
Feb 29, 2016
Status verified
May 2019
Primary completion
Aug 2, 2017
Completion
Jul 26, 2018

Study Design

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

Arms

  • Experimental: Risankizumab
    Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).
  • Placebo Comparator: Placebo
    Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

Primary Outcome Measure

Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]

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