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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

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

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: ustekinumab
* Drug: placebo
* Drug: ustekinumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16 | Drug: placebo<br>* Subcutaneous injection at Week 0 and 4<br>Drug: ustekinumab<br>* 45 mg subcutaneous injection at Week 12 and 16<br>|
| Experimental: 002<br>placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16 | Drug: placebo<br>* Subcutaneous injection at Week 12<br>Drug: ustekinumab<br>* 45 mg subcutaneous injection at Week 0, 4 and 16<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12. | Scores could range from 0 (mild) to 72 (severe). | Baseline (Week 0) to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 |  | Week 12 | 
| The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12. | Scores could range from 0 to 30. A lower DLQI score represents better quality of life. | Baseline (Week 0) to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, asian patients, Chinese, ustekinumab, CNTO 1275, Stelara