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

Recruiting now · Phase 3

Conditions studied: Moderately to Severely Active Ulcerative Colitis

In brief

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).

Key facts

Study ID

NCT07158242

Run by

Hoffmann-La Roche

People needed

100

Starts

2026-04-15

Expected to finish

2031-03-31

Last updated by the study team

2026-07-16

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of South Florida — Tampa, Florida, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Mater Hospital Brisbane — South Brisbane, Queensland, Australia (enrolling)
• Royal Children's Hospital — Parkville, Victoria, Australia (enrolling)
• Perth Children's Hospital — Nedlands, Western Australia, Australia (enrolling)
• Children's Hospital ZheJiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Emmed Research — Pretoria, South Africa (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Chulalongkorn University — Bangkok, Thailand (enrolling)
• Siriraj Hospital — Bangkok, Thailand (enrolling)
• Ramathibodi Hospital — Bangkok, Thailand (enrolling)
• Birmingham Children's Hospital — Birmingham, United Kingdom (enrolling)
• Addenbrooke's Hospital — Cambridge, United Kingdom (enrolling)
• Sheffield Childrens Hospital — Sheffield, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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