At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 478 enrolled
Drug / intervention
Ustekinumab 45 mg +2 moredrug
Likely dose
Ustekinumab 45 mgfrom 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.
A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
In Brief
A Phase 3 clinical trial evaluating Ustekinumab 45 mg, Ustekinumab 90 mg, and 1 other intervention for Psoriasis. Completed, enrolled 478 participants across 40 sites.
Detailed Summary
The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedMar 2012
Primary CompletionMay 2015
Study CompletionJul 2015
TodayJul 2026
First PostedMar 12, 2012
Enrollment StartMar 1, 2012
Primary CompletionMay 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.3 years ago
Interventions
Ustekinumab 45 mgdrug
Form = Injection, route = subcutaneous
Ustekinumab 90 mgdrug
Form = Injection, route = subcutaneous
Placebodrug
Form = Injection, route = subcutaneous