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Clinical Trials in the UK / NCT07158242
Recruiting Phase 3

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

NCT07158242 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2026-04-15
Last updated
2026-09-08

Condition(s) studied

Moderately to Severely Active Ulcerative Colitis

Investigational drug(s) / intervention(s)

Afimkibart

Afimkibart: Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Study 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

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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 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)

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Children's Hospital Colorado Aurora Colorado Recruiting
University of South Florida Tampa Florida Recruiting
Children's Healthcare of Atlanta Atlanta Georgia Recruiting
Northwell Health Lake Success New York Recruiting
NYU Langone Health New York New York Recruiting
Mater Hospital Brisbane South Brisbane Queensland Recruiting
Royal Childrens Hospital Parkville Victoria Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
CECIP - Centro de Estudos Clínicos do Interior Paulista Jaú São Paulo Recruiting
BR Trials - Pesquisa Clínica São Paulo São Paulo Recruiting
Hospital For Sick Children Toronto Ontario Recruiting
Children's Hospital ZheJiang University School of Medicine Hangzhou Zhejiang Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai China Recruiting
IATROS International Bloemfontein South Africa Recruiting
Emmed Research Pretoria South Africa Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Chulalongkorn University Bangkok Thailand Recruiting
Siriraj Hospital Bangkok Thailand Recruiting
Ramathibodi Hospital Bangkok Thailand Recruiting
Birmingham Children's Hospital Birmingham United Kingdom Recruiting
Addenbrooke's Hospital Cambridge United Kingdom Recruiting
Sheffield Childrens Hospital Sheffield United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07158242 on ClinicalTrials.gov ↗ ← All trials in the UK