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Clinical trial

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

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Last updated:1st Mar 2016
Identifier: NCT02684357

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.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)
Actual Study Start Date: March 2016
Actual Primary Completion Date: December 2016
Actual Study Completion Date: September 2017

- Placebo Comparator:
Placebo (Part A)
- Active Comparator: Ustekinumab (Part A)
- Experimental: Risankizumab (Part A)

Category Value
Date last updated at source 2019-07-15
Study type(s) Interventional
Expected enrolment 577
Study start date 2016-03-01
Estimated primary completion date 2016-12-01

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