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

Launched by ABBVIE · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the medicine risankizumab works in children and teenagers with moderate to severe ulcerative colitis, a condition that causes swelling and bleeding in the large intestine. The study aims to see how safe and effective this treatment is in younger patients, and how the medicine moves through their bodies. About 120 young people between the ages of 2 and 17 from around the world may take part.

To join the study, participants need to have active ulcerative colitis confirmed by medical tests and must have tried other treatments without enough success or had trouble with them. The study includes three parts: first, an initial treatment phase where participants get risankizumab through a vein for 12 weeks; then, a maintenance phase where they receive injections under the skin for about a year; and finally, an extension phase that could last up to four years with ongoing treatment. Throughout the study, participants will have regular visits to a clinic for check-ups, blood tests, and to report any side effects. It’s important to know that this study may require more visits and tests than usual care, so families should be prepared for a more involved process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
• * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:
• • aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.
• • - Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.
• Exclusion Criteria:
• • Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
• • Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.