Conditions: Psoriasis
Keywords: ABBV-066 BI 655066 risankizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 577
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.

Arms:
arm 1: Participants were randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). arm 2: 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). arm 3: Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Interventions: intervention 1: risankizumab intervention 2: ustekinumab intervention 3: placebo for risankizumab intervention 4: placebo for ustekinumab
Intervention descriptions: intervention 1: Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection intervention 2: Ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection intervention 3: Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection intervention 4: Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection

Protocol document: