NCT07158242

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Moderately to Severely Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Afimkibart	Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Timeline

• Start date: 2026-04-15
• Primary completion: 2030-03-31
• Completion: 2031-03-31
• First posted: 2025-09-05
• Last updated: 2026-04-13

Locations

6 sites across 3 countries: United States, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study