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Recruiting Phase 3 NCT07158242

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

Phase 3 – large-scale trial before approval
Conditions: Moderately to Severely Active Ulcerative Colitis

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: * 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 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)
Interventions
Afimkibart
DRUG
Locations 9
Taiwan (1)
National Taiwan University Hospital
Taipei
Thailand (3)
Chulalongkorn University
Bangkok
Siriraj Hospital
Bangkok
Ramathibodi Hospital
Bangkok
United Kingdom (3)
Birmingham Children's Hospital
Birmingham
Addenbrooke's Hospital
Cambridge
Sheffield Childrens Hospital
Sheffield
United States (2)
Children's Healthcare of Atlanta
Atlanta , Georgia
NYU School of Medicine
New York , New York
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
15.04.2026
Completion date
31.03.2031
Registry ID
NCT07158242
Source
clinicaltrials.gov
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