Phase 3 Study of Risankizumab to Assess Safety, Effectiveness, and How It Works in Children Ages 2 to Under 18 With Moderate to Severe Ulcerative Colitis

What this Trial Is About

Ulcerative colitis UC is an inflammatory bowel disease causing inflammation and bleeding in the colon and rectum. This trial evaluates how the drug Risankizumab moves through the body and its safety and effectiveness in treating children aged 2 to under 18 years with moderate to severe UC. The study includes about 120 pediatric participants and is sponsored by AbbVie. The trial is divided into three cohorts based on age and three substudies. In Substudy 1 SS1, participants receive a weight-based dose of Risankizumab intravenously for 12 weeks. In Substudy 2 SS2, participants are randomly assigned to one of two weight-based doses of Risankizumab given by subcutaneous injection over 52 weeks in a double-blind maintenance phase. Those completing SS2 may enter Substudy 3 SS3, a 208-week open-label extension where they receive Risankizumab based on their response. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure drug levels in the blood, clinical remission, response rates, and adverse events, with follow-up lasting about 140 days after treatment. The study aims to carefully monitor the treatment effects and safety over a long period.

A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis