CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 110 enrolled
Drug / intervention
Ustekinumab - Half-Standard Dosage +2 moredrug
Likely dose
Ustekinumab - Half-Standard Dosage 0.375 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/NCT01090427
NCT01090427Phase 3Completed
CompareCT.gov

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)

Janssen Research & Development, LLC·interventional·Posted Mar 22, 2010·Updated Jan 29, 2015

In Brief

A Phase 3 clinical trial evaluating Ustekinumab - Half-Standard Dosage, Ustekinumab - Standard Dosage, and 1 other intervention for Psoriasis. Completed, enrolled 110 participants across 50 sites in 10 countries.

Detailed Summary

This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesBelgium, Canada, France, Germany, Hungary, Portugal, Russia, Sweden, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2010
Enrollment StartMay 1, 2010
Primary CompletionJan 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.3 years ago

Interventions

Ustekinumab - Half-Standard Dosagedrug

Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.

Ustekinumab - Standard Dosagedrug

Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.

Placeboother

Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.