CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
Ustekinumab 0.75 mg/kg +2 moredrug
Likely dose
Ustekinumab 0.75 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02698475
NCT02698475Phase 3Completed
CompareCT.gov

A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age

Janssen Research & Development, LLC·interventional·Posted Mar 3, 2016·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, and 1 other intervention for Psoriasis. Completed, enrolled 44 participants across 31 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (\>=) 6 through less than (\<) 12 years with moderate to severe chronic plaque psoriasis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesBelgium, Canada, Germany, Hungary, Netherlands, Poland, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 3, 2016
Enrollment StartMay 1, 2016
Primary CompletionDec 1, 2017
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.3 years ago

Interventions

Ustekinumab 0.75 mg/kgdrug

Participants weighing less than (\<) 60 kilograms will receive ustekinumab 0.75 milligram per kilogram (mg/kg) at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 0.75 mg/kg up to Week 248.

Ustekinumab 45 mgdrug

Participants weighing greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg will receive ustekinumab 45 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 45 mg up to Week 248.

Ustekinumab 90 mgdrug

Participants weighing \>100 kg will receive ustekinumab 90 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 90 mg up to Week 248.