ClinicaliQ Trial Snapshot
- A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis — Recruiting • Phase III • Rheumatology • NCT07071519.
- What is being tested: Risankizumab pharmacokinetics (how the drug moves through the body), safety, and efficacy in paediatric patients with ulcerative colitis, extending evidence from adult populations to younger age groups.
- Patient eligibility overview: Young participants diagnosed with ulcerative colitis who meet specific inclusion criteria; this represents a paediatric population previously under-represented in UC treatment trials.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed. Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study…
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.