Status:
RECRUITING
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Lead Sponsor:
AbbVie
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
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...
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.
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2034
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07071519
Start Date
July 28 2025
End Date
July 1 2034
Last Update
February 11 2026
Active Locations (33)
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1
Phoenix Children's Hospital /ID# 273015
Phoenix, Arizona, United States, 85016
2
Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585
Miami, Florida, United States, 33155
3
Childrens Center For Digestive Health Care /ID# 273228
Atlanta, Georgia, United States, 30342
4
Goryeb Children's Hospital /ID# 271801
Morristown, New Jersey, United States, 07962