How risankizumab works in children and teens with ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 pediatric program uses weight‑based risankizumab dosing across three age cohorts to characterize pharmacokinetics, safety, and clinical effect. Cohort 1 includes ages 6 to <18 years, Cohort 2 includes ages 2 to <6 years, and Cohort 3 includes ages 2 to <18 years, with participants possibly entering up to three substudies. Substudy 1 is an open‑label induction period with weight‑based dosing, and a later substudy includes a double‑blind maintenance period. Key outcome measures include drug levels, adverse events, and changes in disease activity by modified Mayo Score and endoscopic subscore confirmed by a central reader.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:

aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.

\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.

Exclusion Criteria:

* Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
* Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

Where it's running

• Phoenix Children's Hospital /ID# 273015
  Phoenix, Arizona, United States Recruiting
• Rady Children's Hospital /ID# 271873
  San Diego, California, United States Recruiting
• University of California San Francisco - Mission Bay /ID# 273022
  San Francisco, California, United States Recruiting
• Nicklaus Children's Hospital - Miami /ID# 271585
  Miami, Florida, United States Recruiting
• Childrens Center For Digestive Health Care /ID# 273228
  Atlanta, Georgia, United States Recruiting
• University of Chicago Medical Center /ID# 271588
  Chicago, Illinois, United States Recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

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• Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

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• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.