Status:
NOT_YET_RECRUITING
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Moderately to Severely Active Ulcerative Colitis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
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...
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)
Key Trial Info
Start Date :
March 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07158242
Start Date
March 31 2026
End Date
March 31 2031
Last Update
December 22 2025
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