A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease (NCT04673357) | Clinical Trial Compass
CompletedPhase 3
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
United States101 participantsStarted 2021-04-06
Plain-language summary
The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn's disease.
Who can participate
Age range2 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology
* Must have moderately to severely active Crohn's disease (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than \[\>\] 30); have ileocolonoscopy with evidence of active Crohn's disease defined as presence of ulceration (which is equal to Simple Endoscopic Score for Crohn's disease \[SES-CD\] score greater than or equals to \[\>=\] 3) during screening into this study. The ileocolonoscopy procedure must occur within approximately 3 weeks prior to the administration of study intervention at Week 0 (Induction Period). A video ileocolonoscopy recorded within 3 months prior to the Week 0 (Induction Period) visit may be used in case of rescreening of a participant who had an ileocolonoscopy but failed the initial screening for another reason, on a case-by-case basis, after consultation with the sponsor. If unable to evaluate ulceration due to stricture or inadequate bowel preparation, at least one of the following criteria may instead be applied: an abnormal C-reactive protein (CRP) (\> 0.3 milligram per deciliter \[mg/dL\] or 3.0 milligram per liter \[mg/L\] at screening) or; fecal calprotectin of \>= 250 milligram per kilogram \[mg/kg\] or \>= 250 microgram per gram \[mcg/g\] at screening
* If receiving enteral nutrition, must have been on a stable regimen for …
What they're measuring
1
Number of Participants with Clinical Remission at Induction Week 8
Timeframe: Week 8
2
Number of Participants with Adverse Events (AEs)
Timeframe: Up to Week 74
3
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to Week 74
4
Number of Participants with AEs leading to Discontinuation of Study Intervention
Timeframe: Up to Week 74
5
Number of Participants with AEs of Interest
Timeframe: Up to Week 74
6
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Timeframe: Up to Week 52
7
Number of Participants with Reactions Temporally Associated with Intravenous (IV) Infusion (Induction Period)
Timeframe: Up to Week 8 (Induction period)
8
Number of Participants with Subcutaneous (SC) Injection-Site Reactions (Maintenance Period)