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

In plain English

What this trial is testing

This study is testing Risankizumab (a drug) and Risankizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 2 to 17
• Any sex

Some of the main requirements, copied from the record:

• 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…
• \- 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…

There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 120 participants are expected to take part.
• The study has 15 groups.
• Start date: 2025-07-28.
• Main results expected around 2034-07 (estimate from the record).
• 68 study sites listed (68 marked recruiting) in Belgium, Brazil, Canada, China and Germany and 11 more countries.

Groups in this study

• PK Cohort 1: SS1 (listed as: experimental group)
• PK Cohort 1: SS2 Dose A (listed as: experimental group)
• PK Cohort 1: SS2 Dose B (listed as: experimental group)
• PK Cohort 1: SS3 Dose A (listed as: experimental group)
• PK Cohort 1: SS3 Dose B (listed as: experimental group)
• PK Cohort 2: SS1 (listed as: experimental group)

Main thing being measured

• PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax) (At Week 64)
• PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax) (At Week 64)
• PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax) (At Week 64)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.