At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 158 enrolled

Drug / intervention

Placebo (CP) +6 moredrug

Likely dose

Ustekinumab 45 mg (CP)from 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/NCT00723528

NCT00723528Phase 3Completed

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A Placebo-Controlled Double-Blind Comparative Study of CNTO1275 in Patients With Plaque Type Psoriasis

Janssen Pharmaceutical K.K.·interventional·Posted Jul 28, 2008·Updated May 20, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo (CP), Ustekinumab 45 mg (CP), and 5 other interventions for Psoriasis. Completed, enrolled 158 participants across 27 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of ustekinumab (CNTO 1275) compared with placebo in participants with moderate to severe plaque type psoriasis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPsoriasis

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2008

First PostedJul 2008

Primary CompletionJan 2009

Study CompletionMar 2010

TodayJul 2026

First PostedJul 28, 2008

Enrollment StartMar 1, 2008

Primary CompletionJan 1, 2009

Study CompletionMar 1, 2010

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 17.9 years ago

Interventions

Placebo (CP)drug

Placebo 0.5 ml and 1.0 ml will be administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).

Ustekinumab 45 mg (CP)drug

Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).

Ustekinumab 90 mg (CP)drug

Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC on Weeks 0 and 4 during controlled period (Weeks 0-12).

Placebo A (After CP)drug

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group will be randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.

Placebo B (After CP)drug

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group will be randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) will be administered SC at Weeks 12, 16, 28, 40, and 52.

Ustekinumab 45 mg (After CP)drug

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.

Ustekinumab 90 mg (After CP)drug

After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group will receive placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.