Actively Recruiting
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Led by Hoffmann-La Roche · Updated on 2026-04-23
100
Participants Needed
9
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bodyweight >= 10 kilogram (kg)
- Confirmed diagnosis of ulcerative colitis
- Intolerance or inadequate response to systemic corticosteroids, immunomodulators, and/or biologic therapies
You will not qualify if you...
- Monogenic disorder related to infant onset inflammatory bowel disease
- Current diagnosis of Crohn's disease, abdominal/intrabdominal/perianal fistula 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
- Major surgery within 6 weeks prior to screening or planned major surgery during the study
- Active tuberculosis infection indicated by positive TB test, symptoms, or chest imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
2
NYU School of Medicine
New York, New York, United States, 10016
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
4
Chulalongkorn University
Bangkok, Thailand, 10330
Actively Recruiting
5
Siriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
6
Ramathibodi Hospital
Bangkok, Thailand
Actively Recruiting
7
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
8
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
9
Sheffield Childrens Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
R
Reference Study ID Number: CA45905 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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