At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 766 enrolled

Drug / intervention

ustekinumab +1 moredrug

Likely dose

ustekinumab 90, Unitfrom 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/NCT00267969

NCT00267969Phase 3Completed

Compare CT.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial Evaluating the Efficacy and Safety of Ustekinumab (CNTO 1275) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis

Centocor Research & Development, Inc.·interventional·Posted Dec 22, 2005·Updated Jun 17, 2013

In Brief

A Phase 3 clinical trial evaluating ustekinumab and placebo for Psoriasis. Completed, enrolled 766 participants across 42 sites in 3 countries.

Detailed Summary

The primary purpose of this study is to evaluate the effectiveness and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPsoriasis

CountriesBelgium, Canada, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2005

First PostedDec 2005

Primary CompletionJul 2006

Study CompletionMay 2011

TodayJul 2026

First PostedDec 22, 2005

Enrollment StartDec 1, 2005

Primary CompletionJul 1, 2006

Study CompletionMay 1, 2011

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 20.5 years ago

Interventions

ustekinumabdrug

Type = exact number, Form = solution for injection, Number = 45 and 90, Unit = mg, Route = subcutaneous (SC) administered at Weeks 0, 4 and 16. Both treatments (45 mg and 90 mg) administered every 12 weeks after Week 16 depending on clinical response.

placebodrug

Form = solution for injection, route = SC administered at Weeks 0 and 4. At Weeks 12 and 16, placebo will be crossed over to receive ustekinumab 45 mg or 90 mg.