RecruitingPhase 3NCT07158242

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

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


Sponsor

Hoffmann-La Roche

Enrollment

100 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new biologic medication called afimkibart (RO7790121) in children with moderately to severely active ulcerative colitis (UC) — a condition that causes chronic inflammation and sores in the large intestine — who have not responded well enough to standard treatments. **You may be eligible if...** - You are a child with a confirmed diagnosis of ulcerative colitis - You weigh at least 10 kg (about 22 lbs) - Your UC has not responded adequately to, or you could not tolerate, standard treatments including steroids, immunosuppressants, or biologic therapies **You may NOT be eligible if...** - You have Crohn's disease, indeterminate colitis, or infectious colitis - You have a colostomy or ileoanal pouch - You have active tuberculosis - You had major surgery within the past 6 weeks - You are suspected of having primary sclerosing cholangitis (a liver condition) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAfimkibart

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


Locations(9)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

NYU School of Medicine

New York, New York, United States

National Taiwan University Hospital

Taipei, Taiwan

Chulalongkorn University

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Birmingham Children's Hospital

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Sheffield Childrens Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07158242


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