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Clinical trial

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

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Last updated:1st Mar 2016
Identifier: NCT02694523

Brief Summary:
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.

Detailed Description:
This study consists of 2 parts (Part A and Part B).
Part A:
- Participants were randomized to receive either risankizumab or adalimumab.

Part B:
- Participants who received risankizumab in Part A continued to receive risankizumab in Part B
- Adalimumab nonresponders (<PASI 50 at Week 16) switched to risankizumab in Part B;
- Adalimumab responders (PASI 90 at Week 16) continued to received adalimumab in Part B;
- Adalimumab inadequate responders (PASI 50 to <PASI 90) were rerandomized to receive either risankizumab or adalimumab in Part B.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
Actual Study Start Date: March 2016
Actual Primary Completion Date: August 2017
Actual Study Completion Date: August 2017

- Active Comparator:
Adalimumab (Part A)
- Experimental: Risankizumab (Part A)

Category Value
Date last updated at source 2019-05-27
Study type(s) Interventional
Expected enrolment 684
Study start date 2016-03-01
Estimated primary completion date 2017-08-01

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