BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis

Sponsor
AbbVie
Study ID
NCT02719171
Phase
PHASE2
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

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

Interventions

Study Details

The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.

Key Dates

Start date
Apr 30, 2016
Status verified
May 2019
Primary completion
May 31, 2017
Completion
Aug 31, 2017

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
  • Experimental: Risankizumab 150 mg Every 4 Weeks
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
  • Experimental: Risankizumab 150 mg Weeks 0, 4, and 16
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
  • Experimental: Risankizumab 150 mg Weeks 0 and 12
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
  • Experimental: Risankizumab 75 mg Week 0
    Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Week 16 ]

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