At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,230 enrolled

Drug / intervention

Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg +2 moredrug

Likely dose

Ustekinumab 45 or 90 mg subcutaneously at weeks 0 and 4, then every 12 weeksAI-extracted

Key inclusion· 4

✓Plaque-type psoriasis diagnosed ≥6 months prior
✓Plaque-type psoriasis covering at least 10% of total body surface area
✓Psoriasis Area-and-Severity Index (PASI) score ≥12 at screening and baseline
✓Candidate for phototherapy or systemic treatment per treating dermatologist

Key exclusion· 9

✕Non-plaque forms of psoriasis or drug-induced psoriasis
✕Prior use of therapeutic agents targeting IL-12 or IL-23
✕BCG vaccination within 12 months prior to screening
✕Chronic or recurrent infectious disease or serious infection requiring hospitalization or IV antibiotics within 2 months prior to screening

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

Search/NCT00307437

NCT00307437Phase 3Completed

Compare CT.gov

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

Centocor Research & Development, Inc.·interventional·Posted Mar 28, 2006·Updated Jan 24, 2013

In Brief

A Phase 3 clinical trial evaluating Placebo; Ustekinumab (CNTO 1275) 45 or 90 mg, Ustekinumab (CNTO 1275) 45 mg, and 1 other intervention for Psoriasis. Completed, enrolled 1,230 participants across 62 sites in 7 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy 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

CountriesAustria, Canada, France, Germany, Switzerland, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2005

First PostedMar 2006

Primary CompletionDec 2006

Study CompletionOct 2011

TodayJul 2026

First PostedMar 28, 2006

Enrollment StartMay 1, 2005

Primary CompletionDec 1, 2006

Study CompletionOct 1, 2011

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 20.3 years ago

Interventions

Placebo; Ustekinumab (CNTO 1275) 45 or 90 mgdrug

Placebo at Weeks 0 and 4 and blinded SC injections of ustekinumab, 45 or 90 mg, at Weeks 12 and 16; followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

Ustekinumab (CNTO 1275) 45 mgdrug

Ustekinumab, 45 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264

Ustekinumab (CNTO 1275) 90 mgdrug

Ustekinumab, 90 mg, at Weeks 0 and 4 and every 12 weeks for Weeks 16 to 28. Followed by a dosing regimen to be determined by patient's response status for Weeks 28 to 52; followed by unblinded dosing that may be adjusted at the investigator's discretion for Weeks 52 to 264