A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Purpose
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Condition
- Ulcerative Colitis (UC)
Eligibility
- Eligible Ages
- Between 16 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Exclusion Criteria
- Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study. - Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. - Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Substudy 1: Double-blind Placebo |
Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection. |
|
|
Experimental Substudy 1: Double-blind Risankizumab Dose 1 |
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. |
|
|
Experimental Substudy 1: Double-blind Risankizumab Dose 2 |
Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection. |
|
|
Experimental Substudy 2: Open-label (OL) Clinical Assessment Risankizumab |
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. |
|
|
Experimental Substudy 2: OL Therapeutic Drug Monitoring Risankizumab |
Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection. |
|
|
Experimental Substudy 3: OL Extension Risankizumab |
Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3. |
|
|
Experimental OL Continuous Treatment Extension - Dose 1 |
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 without receiving risankizumab rescue therapy in any sub-study will receive risankizumab Dose 1 administered by subcutaneous (SC) injection. |
|
|
Experimental OL Continuous Treatment Extension - Dose 2 |
Participants who complete Sub-study 3 and continue to tolerate and derive benefit from receiving risankizumab, will continue to receive risankizumab based on their assignment during Sub-study 3. Participants completing Sub-study 3 and received risankizumab rescue therapy in any sub-study will receive risankizumab Dose 2 administered by subcutaneous (SC) injection. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- AbbVie