Afimkibart for children with moderately to severely active 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 randomized, double-blind, multicenter Phase III trial enrolls pediatric participants with moderate to severe active ulcerative colitis who have had inadequate response or intolerance to systemic corticosteroids, immunomodulators, or biologic therapies. Participants receive Afimkibart during an induction period and responders enter a maintenance phase to compare longer-term efficacy and safety against placebo or comparator. The protocol includes pharmacokinetic sampling to establish pediatric dosing, regular safety monitoring, and efficacy endpoints such as clinical remission and symptom improvement. The study is conducted at major pediatric and academic centers in the United States and Taiwan.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Bodyweight \>= 10 kilogram (kg)
* Confirmed diagnosis of UC
* Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)
* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol

Exclusion Criteria:

* Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)
* Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Any major surgery within 6 weeks prior to screening or a major planned surgery during the study
* Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• Northwell Health
  Lake Success, New York, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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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.