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RECRUITING
NCT07158242
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03-31

Completion Date

2031-03-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Afimkibart

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

Locations (4)

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

Addenbrooke's Hospital

Cambridge, United Kingdom