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Afimkibart for Children with Ulcerative Colitis

This study is testing a drug called Afimkibart (RO7790121) in children aged 2 to 17 years old who have moderately to severely active ulcerative colitis (UC). Ulcerative colitis is a chronic inflammatory bowel disease. The study aims to see how safe and effective Afimkibart is when given as an intravenous (IV) infusion or a subcutaneous (SC) injection. To join, children must weigh at least 10 kg, have a confirmed UC diagnosis, and have not responded well to other UC treatments. The main goals are to see what percentage of participants achieve clinical remission (a period where symptoms are reduced or absent) at 12 weeks and again at 52 weeks. The study plans to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is a Phase III, randomized, double-blind, multicenter study. It will include about 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be evaluated for clinical remission at 12 weeks and again at 52 weeks.

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NCT07158242

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

Recruiting
PHASE3Ages 2–17InterventionalTreatment
Hoffmann-La Roche
~100 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Afimkibart

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Clinical Remission at Week 12
Measured over At Week 12
+1 more outcome measured

Conditions

Moderately to Severely Active Ulcerative Colitis

Explore related trials

Ulcerative Colitis

Where it's being run

22 sites across 15 states
Thailand3
United Kingdom3
New York2
São Paulo2
South Africa2
Colorado1
Florida1
Georgia1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
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Eligibility criteria

Inclusion

Bodyweight \>= 10 kilogram (kg)
Confirmed diagnosis of UC
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

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)

What this trial measures

  • Percentage of Participants with Clinical Remission at Week 12At Week 12
  • Percentage of Participants with Clinical Remission at Week 52At Week 52