A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.

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Detailed Description

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In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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001

placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Subcutaneous injection at Week 0 and 4

ustekinumab

Intervention Type DRUG

45 mg subcutaneous injection at Week 12 and 16

002

placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Subcutaneous injection at Week 12

ustekinumab

Intervention Type DRUG

45 mg subcutaneous injection at Week 0, 4 and 16

Interventions

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placebo

Subcutaneous injection at Week 0 and 4

Intervention Type DRUG

ustekinumab

45 mg subcutaneous injection at Week 12 and 16

Intervention Type DRUG

placebo

Subcutaneous injection at Week 12

Intervention Type DRUG

ustekinumab

45 mg subcutaneous injection at Week 0, 4 and 16

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be of Chinese ancestry
* Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start
* Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of study start
* Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start
* Must be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment)

Exclusion Criteria

* Currently have nonplaque forms of psoriasis
* Have current drug-induced psoriasis
* Have used any investigational drug within the previous 4 weeks
* Have used any biologic within the previous 3 months
* Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No