NCT07298421

A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

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 Crohn's Disease

• Status: Not Yet 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, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Conditions

• Moderately to Severely Active Crohns Disease

Interventions

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

Timeline

• Start date: 2026-05-29
• Primary completion: 2030-05-31
• Completion: 2031-05-30
• First posted: 2025-12-23
• Last updated: 2026-04-17

Regulatory

• FDA-regulated drug study