Actively Recruiting
A Phase III Randomized Double-Blind Multi-Center Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Induction and Maintenance Therapy with Afimkibart (RO7790121) in Children Aged 2 to 17 Years with Moderately to Severely Active Ulcerative Colitis
Led by Hoffmann-La Roche · Updated on 2026-05-22
100
Participants Needed
12
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Afimkibart (RO7790121) in children aged 2 to 17 years with moderate to severe active ulcerative colitis (UC). This Phase III, randomized, double-blind, multicenter study aims to assess the safety and effectiveness of Afimkibart as both induction and maintenance therapy in this pediatric population. Participants will receive Afimkibart first as an intravenous (IV) infusion, followed by subcutaneous (SC) injections. The study includes two dosing groups, both involving this IV to SC treatment approach. The trial will monitor participants through induction and maintenance phases to evaluate treatment effects over time. During the study, researchers will assess clinical remission at weeks 12 and 52, using measures such as the Pediatric Ulcerative Colitis Activity Index (PUCAI), TUMMY-UC scores, and endoscopic and histologic improvements. Safety will be monitored through adverse event tracking and serum drug concentration measurements for up to approximately four years. Participants will be closely followed to evaluate both therapeutic response and long-term safety.
CONDITIONS
Brief 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 at least 10 kilograms
- Confirmed diagnosis of ulcerative colitis
- Prior intolerance or inadequate response to corticosteroids, immunomodulators, or biologic therapies
You will not qualify if you...
- Monogenic disorder related to infant onset inflammatory bowel disease
- Diagnosis of Crohn's disease, fistulas, abscesses, indeterminate colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
- Presence of an ostomy or ileoanal pouch
- Diagnosis or suspicion of primary sclerosing cholangitis
- Major surgery within 6 weeks before screening or planned major surgery during the study
- Active tuberculosis infection indicated by positive tests or symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive induction and maintenance therapy with Afimkibart through intravenous infusion followed by subcutaneous injections.
Trial Site Locations
Total: 12 locations
1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
3
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
4
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
5
Children's Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
6
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
7
Chulalongkorn University
Bangkok, Thailand, 10330
Actively Recruiting
8
Siriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
9
Ramathibodi Hospital
Bangkok, Thailand
Actively Recruiting
10
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
11
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
12
Sheffield Childrens Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
R
Reference Study ID Number: CA45905 https://forpatients.roche.com/
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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