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Monoclonal Antibodies

Risankizumab for Ulcerative Colitis (COMMAND Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 300
Awards & highlights
Pivotal Trial

Summary

This trial will assess the safety and efficacy of risankizumab as a treatment for ulcerative colitis. The study will last for 52 weeks and will compare the results of those taking risankizumab to those taking a placebo.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to risankizumab or its components. Side effects experienced in the earlier phase of the trial could also be relevant.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic to risankizumab, its ingredients, or products from Chinese hamster ovary cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 300
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 300 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Adverse Events (AE)
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Secondary study objectives
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms
+14 more

Side effects data

From 2020 Phase 3 trial • 18 Patients • NCT03022045
25%
Urticaria
25%
Erythema
25%
Viral upper respiratory tract infection
25%
Aspartate aminotransferase increased
25%
Gamma-glutamyltransferase increased
25%
Rash
25%
Osteoarthritis
25%
Hepatic function abnormal
25%
Alanine aminotransferase increased
25%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
GPP Risankizumab 75 mg
EP Risankizumab 150 mg
GPP Risankizumab 150 mg
EP Risankizumab 75 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
risankizumab
2016
Completed Phase 3
~5570

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,020 Previous Clinical Trials
518,849 Total Patients Enrolled
18 Trials studying Ulcerative Colitis
6,067 Patients Enrolled for Ulcerative Colitis
ABBVIE INC.Study DirectorAbbVie
442 Previous Clinical Trials
159,298 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
3,021 Patients Enrolled for Ulcerative Colitis

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03398135 — Phase 3
Ulcerative Colitis Research Study Groups: OL Continuous Treatment Extension - Dose 2, Substudy 1: Double-blind Risankizumab Dose 2, Substudy 3: OL Extension Risankizumab, Substudy 2: OL Therapeutic Drug Monitoring Risankizumab, Substudy 2: Open-label (OL) Clinical Assessment Risankizumab, OL Continuous Treatment Extension - Dose 1, Substudy 1: Double-blind Placebo, Substudy 1: Double-blind Risankizumab Dose 1
Ulcerative Colitis Clinical Trial 2023: Risankizumab Highlights & Side Effects. Trial Name: NCT03398135 — Phase 3
Risankizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03398135 — Phase 3
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