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RECRUITING
NCT07298421
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

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 Crohn's Disease

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05-29

Completion Date

2031-05-30

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

DRUG

Afimkibart

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

Locations (2)

Perth Children's Hospital

Nedlands, Western Australia, Australia

National Taiwan University Hospital

Taipei, Taiwan