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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Risankizumab (drug), Risankizumab (drug)
How long the study runs: Study runs about 108 months (dates as stated)
About the drug or intervention: Risankizumab — drug: Risankizumab intravenous (IV) infusion · Risankizumab — drug: Risankizumab subcutaneous (SC) injection
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 2 Years to 17 Years
Who: All
Number of participants: 120
Started: 2025-07-28
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for ulcerative colitis
• Phase3 - 120 participants
• 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)

Who can take part?

• Ages 2 Years to 17 Years
• Diagnosed with ulcerative colitis

Where?

• Cambridge - Addenbrookes Hospital /ID# 271489
• Sheffield - Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
• Liverpool - Alder Hey Children's NHS Foundation Trust /ID# 271533

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Ulcerative Colitis

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 2 Years - 17 Years
Who can join: All genders

Treatment history

Treatments you must have had:

✓ a documented history of UC for at least 3 months

What the study is looking for

✓Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3...
✓Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:

Who cannot take part

✗Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct...

See the full 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.

Where Is This Study? (3 UK sites)

Addenbrookes Hospital /ID# 271489

Cambridge CB2 2QQ, United Kingdom

Recruiting

Sheffield Children's Hospital NHS Foundation Trust /ID# 271490

Sheffield S10 2TH, United Kingdom

Recruiting

Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net 0114 2712550

Alder Hey Children's NHS Foundation Trust /ID# 271533

Liverpool L12 2AP, United Kingdom

Recruiting

Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk 0151 2525570

How to Get in Touch

ABBVIE CALL CENTER

Sponsor contact

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-10