Tests afimkibart in children with active ulcerative colitis
Tests afimkibart in children aged 2 to 17 with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Atlanta, Aurora, Cleveland, Harlingen, Hartford, Lake Success, New York, Pittsburgh, St Louis, and Tampa, United StatesSee the 10 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT07158242, who can take part
Where in United States
- Children's Healthcare of AtlantaAtlanta, United StatesTaking people
- Children's Hospital ColoradoAurora, United StatesTaking people
- Cleveland Clinic;Children's InstituteCleveland, United StatesTaking people
- Texas Digestive SpecialistsHarlingen, United StatesTaking people
- Connecticut Children's Medical CenterHartford, United StatesTaking people
- Northwell HealthLake Success, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- UPMC Childen?s Hospital of PittsburghPittsburgh, United StatesTaking people
- Washington UniversitySt Louis, United StatesTaking people
- University of South FloridaTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07158242EU 2025-522518-22-01
- Record updated
- 5 November 2026
- Original description
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).Read full original descriptionShow less
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis
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).
Inclusion: Bodyweight >= 10 kilogram (kg); Confirmed diagnosis of UC; Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy); 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: Any major surgery within 6 weeks prior to screening or a major planned surgery during the study; 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; Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT); Presence of an ostomy or ileoanal pouch; Current diagnosis or suspicion of primary sclerosing cholangitis.