A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

Summary

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Crohn's Disease

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

2 to 17 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

AbbVie

Last updated on ClinicalTrials.gov

September 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites