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โ† Trials
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A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

RecruitingPhase 3Ages 2 Years - 17 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 parti

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Risankizumab
  • Risankizumab
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Where

72 sites
Phoenix Children's Hospital /ID# 273015
Phoenix, United States
Rady Children's Hospital /ID# 271873
San Diego, United States
University of California San Francisco - Mission Bay /ID# 273022
San Francisco, United States
Nicklaus Children's Hospital - Miami /ID# 271585
Miami, United States
Childrens Center For Digestive Health Care /ID# 273228
Atlanta, United States
University of Chicago Medical Center /ID# 271588
Chicago, United States
Goryeb Children's Hospital /ID# 271801
Morristown, United States
University Hospitals Cleveland Medical Center /ID# 271831
Cleveland, United States

โ€ฆand 64 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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