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
- Hangzhou and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 2 to 17 with moderately to severely active ulcerative colitis who did not do well on, or could not tolerate, earlier treatment.
- Age
- 2 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed ulcerative colitis that is moderately to severely active: modified Mayo Score of 5 to 9 points, with an endoscopic score of 2 or 3, confirmed by a central reading of the endoscopy.
- Earlier treatment
- Must have had intolerance or an inadequate response to one or more of: systemic corticosteroids, immunomodulators, and/or biologic therapies.
Main reasons for not taking part
- Body weight under 10 kg (22 lb)
- Crohn's disease or other kinds of colitis, fistula or abscess
- An ostomy or ileoanal pouch
- Primary sclerosing cholangitis, current or suspected
- Major surgery within 6 weeks before screening, or planned during the study
Read by machine on 9 November 2026.
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 China
- Children's Hospital, Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.