Risankizumab for Ulcerative Colitis
(COMMAND Trial)

Recruiting in Palo Alto (17 mi)

+692 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people with ulcerative colitis who responded to risankizumab in a previous study. They must not have allergies to risankizumab, its ingredients, or substances from Chinese hamster ovary cells. Participants should be compliant with medication requirements from the prior study.

Inclusion Criteria

Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria

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.

I am not allergic to risankizumab, its ingredients, or products from Chinese hamster ovary cells.

Treatment Details

Interventions

Risankizumab (Monoclonal Antibodies)

Trial OverviewThe trial tests the safety and effectiveness of risankizumab over 52 weeks compared to a placebo. It includes three sub-studies: one double-blind controlled study, one exploratory study, and an open-label extension for certain participants affected by COVID-19 or geopolitical issues.

Participant Groups

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Substudy 3: OL Extension RisankizumabExperimental Treatment1 Intervention

Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.

Group II: Substudy 2: Open-label (OL) Clinical Assessment RisankizumabExperimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Group III: Substudy 2: OL Therapeutic Drug Monitoring RisankizumabExperimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Group IV: Substudy 1: Double-blind Risankizumab Dose 2Experimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.

Group V: Substudy 1: Double-blind Risankizumab Dose 1Experimental Treatment1 Intervention

Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.

Group VI: OL Continuous Treatment Extension - Dose 2Experimental Treatment1 Intervention

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.

Group VII: OL Continuous Treatment Extension - Dose 1Experimental Treatment1 Intervention

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.

Group VIII: Substudy 1: Double-blind PlaceboPlacebo Group1 Intervention

Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.

Risankizumab is already approved in Canada for the following indications: