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โ† Trials
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A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

RecruitingPhase 3Ages 2 Years - 17 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Bodyweight \>= 10 kilogram (kg) * Confirmed diagnosis of UC * Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy) * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol Exclusion Criteria: * Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD) * Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis * Any major surgery within 6 weeks prior to screening or a major planned surgery during the study * Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
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What it tests

  • Afimkibart
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Where

26 sites
Children's Hospital Colorado
Aurora, United States
Connecticut Children's Medical Center
Hartford, United States
University of South Florida
Tampa, United States
Children's Healthcare of Atlanta
Atlanta, United States
Washington University
St Louis, United States
Northwell Health
Lake Success, United States
NYU Langone Health
New York, United States
UPMC Childen?s Hospital of Pittsburgh
Pittsburgh, United States

โ€ฆand 18 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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