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A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

RecruitingPhase 3

A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis

Who can join

Ages 2 to 17 · All sexes

Full eligibility criteria
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)

About the study

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 100 · Started: Apr 15, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07158242

Locations in the U.S.

ColoradoChildren's Hospital Colorado, Aurora
FloridaUniversity of South Florida, Tampa
GeorgiaChildren's Healthcare of Atlanta, Atlanta
New YorkNorthwell Health, Lake Success
NYU Langone Health, New York

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.