RecruitingPhase 3NCT07298421

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


Sponsor

Hoffmann-La Roche

Enrollment

100 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Afimkibart for people with moderately to severely active crohns disease. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 2 Years to 17 Years.

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(5)

Royal Children's Hospital

Parkville, Victoria, Australia

Perth Children's Hospital

Nedlands, Western Australia, Australia

National Taiwan University Hospital

Taipei, Taiwan

Chulalongkorn University

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

View Full Details on ClinicalTrials.gov

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NCT07298421


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