Risankizumab Treatment Study for Children Aged 2 to Under 18 with Moderate to Severe Crohns Disease Including IV Induction and SC Maintenance Phases

What this Trial Is About

Crohns Disease CD is a digestive condition causing symptoms like chronic diarrhea, abdominal pain, weight loss, and fever. This research evaluates the pharmacokinetics, safety, and effectiveness of risankizumab in children aged 2 to under 18 years with moderately to severely active CD who have not responded well or cannot tolerate other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is now being studied for pediatric CD. The study includes three groups based on age, enrolling children from 2 to less than 18 years old. It has three parts an open-label 12-week induction phase where participants receive intravenous risankizumab based on their weight, a 52-week double-blind maintenance phase with subcutaneous risankizumab at one of two doses, and a 208-week open-label extension phase where treatment continues based on earlier responses. Participants who complete each phase may continue to the next, with dosing adjusted by age group. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and questionnaires to monitor disease activity, side effects, and drug levels. Researchers will measure outcomes such as clinical remission and endoscopic response at 12 and 64 weeks, along with drug concentration in the blood. The total follow-up after treatment lasts about 140 days, with long-term monitoring during the extension phase.

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