A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
AbbVie · NCT07071519
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 2–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 120
- US sites recruiting
- 12
- Study start
- July 28, 2025
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Risankizumab; Risankizumab
Conditions: Ulcerative Colitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show 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.
Recruiting US locations
Phoenix Children's Hospital /ID# 273015
Phoenix, AZ 85016
Rady Children's Hospital /ID# 271873
San Diego, CA 92123
University of California San Francisco - Mission Bay /ID# 273022
San Francisco, CA 94158
Nicklaus Children's Hospital - Miami /ID# 271585
Miami, FL 33155
Childrens Center For Digestive Health Care /ID# 273228
Atlanta, GA 30342
University of Chicago Medical Center /ID# 271588
Chicago, IL 60637
Goryeb Children's Hospital /ID# 271801
Morristown, NJ 07962
University Hospitals Cleveland Medical Center /ID# 271831
Cleveland, OH 44106
The Children's Hospital of Philadelphia /ID# 273222
Philadelphia, PA 19104
Upmc Children'S Hospital Of Pittsburgh /ID# 272328
Pittsburgh, PA 15224
Patewood Medical Campus /ID# 272477
Greenville, SC 29615
University of Texas - Southwestern Medical Center /ID# 271835
Dallas, TX 75235
Study contacts (from the official record)
- ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com