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NCT07158242PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

4/15/2026

Completion Date

3/31/2031

Summary

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).

Eligibility Criteria

Age Range: 2 years to 17 years

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

DRUG

Afimkibart

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Conditions

Moderately to Severely Active Ulcerative Colitis

Locations

University of South Florida

Tampa, Florida 33612

United States

Children's Healthcare of Atlanta

Atlanta, Georgia 30342

United States

NYU Langone Health

New York, New York 10016

United States

Mater Hospital Brisbane

South Brisbane, Queensland 4101

Australia

Royal Children's Hospital

Parkville, Victoria 3052

Australia

Perth Children's Hospital

Nedlands, Western Australia 6009

Australia

Children's Hospital ZheJiang University School of Medicine

Hangzhou, Zhejiang 310052

China

Emmed Research

Pretoria, 0002

South Africa

National Taiwan University Hospital

Taipei, 100

Taiwan

Chulalongkorn University

Bangkok, 10330

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Ramathibodi Hospital

Bangkok,

Thailand

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 0QQ

United Kingdom

Sheffield Childrens Hospital

Sheffield, S10 2TH

United Kingdom