A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Col… (NCT06260163) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
United States, Australia112 participantsStarted 2024-01-19
Plain-language summary
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion Criteria:
* Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening
* A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
* Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy
* Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
* Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
Exclusion Criteria:
* Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon
* Presence of a stoma
* Has had any kind of bowel resection within 6 months or any other …
What they're measuring
1
Percentage of Participants with Clinical Remission at Week 56