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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 300

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

50%

Dehydration

25%

Inflammation

25%

Constipation

25%

Acne

25%

Pyrexia

25%

Pain in extremity

25%

Gastric cancer

25%

Alcoholic liver disease

25%

Hypoglycaemia

25%

Abdominal pain upper

25%

Vomiting

25%

Hepatic function abnormal

25%

Decreased appetite

25%

Depression

25%

Ear infection

25%

Viral upper respiratory tract infection

25%

Haemorrhage subcutaneous

25%

Rash

100%

80%

60%

40%

20%

Study treatment Arm

GPP Risankizumab 150 mg

EP Risankizumab 150 mg

GPP Risankizumab 75 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

0 / 1Eligibility criteria met