jRCT2071230116RecruitingNot Applicable
A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 120
- Primary Endpoint
- Percentage of Participants with Clinical Remission at Week 56
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 2age old over to 17age old under (—)
- Sex
- All
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, and a baseline Mayo rectal bleeding subscore >=1
- •Medically stable on the basis of 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 intra-abdominal surgery within 3 months of baseline
- •Have severe colitis or have evidence of Crohn's Disease (CD)
Outcomes
Primary Outcomes
Percentage of Participants with Clinical Remission at Week 56
Time Frame: Week 56
Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Secondary Outcomes
No secondary outcomes reported
Investigators
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