Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03398135

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cemic /Id# 167805, Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risankizumab

Drug

subcutaneous (SC) injection

Other names: ABBV-066, BI 655066, SKYRIZI

placebo for risankizumab

Drug

subcutaneous (SC) injection

Primary outcomes

  1. Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score

    Time frame: Week 52

    Clinical remission per Adapted Mayo Score.

  2. Percentage of Participants with Adverse Events (AE)

    Time frame: Up to Week 300

    An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement

    Time frame: Week 52

    Endoscopic improvement per endoscopy subscore.

  2. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

    Time frame: Week 52

    Percentage of participants achieving histologic-endoscopic mucosal improvement.

  3. Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission

    Time frame: Week 52

    Endoscopic remission per endoscopy subscore.

  4. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days

    Time frame: Week 52

    Clinical remission per Adapted Mayo Score.

  5. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0

    Time frame: Week 52

    Clinical remission per Adapted Mayo Score.

  6. Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency

    Time frame: Week 52

    Percentage of participants achieving no bowel urgency.

  7. Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain

    Time frame: Week 52

    Percentage of participants achieving no abdominal pain.

  8. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission

    Time frame: Week 52

    Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.

  9. Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0

    Time frame: Week 52

    Endoscopic improvement per endoscopy subscore.

  10. Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score

    Time frame: Week 52

    Clinical response per Adapted Mayo Score.

  11. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

    Time frame: Week 0 to Week 52

    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

  12. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: Baseline (Week 0) to Week 52

    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  13. Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements

    Time frame: Week 52

    Percentage of participants achieving no nocturnal bowel movements.

  14. Sub-Study 1: Percentage of Participants Achieving No Tenesmus

    Time frame: Week 52

    Percentage of participants achieving no tenesmus.

  15. Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week

    Time frame: Baseline (Week 0) to Week 52

    Change in number of fecal incontinence episodes per week.

  16. Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms

    Time frame: Baseline (Week 0) to Week 52

    Change in number of days per week with sleep interrupted due to UC symptoms.

  17. Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization

    Time frame: Through Week 52

    Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

Acronym: COMMAND

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Jan 12, 2018
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.