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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: placebo; Drug: ustekinumab; Drug: placebo; Drug: ustekinumab

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

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Chongqing, China
  • Dalian, China
  • Guangzhou, China
  • Hangzhou, China
  • Nanjing, China
  • Shanghai, China
  • Shenyang, China
  • Xi'An, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 001; placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16	Drug: placebo; Subcutaneous injection at Week 0 and 4; Drug: ustekinumab; 45 mg subcutaneous injection at Week 12 and 16; Drug: placebo; Subcutaneous injection at Week 12; Drug: ustekinumab; 45 mg subcutaneous injection at Week 0, 4 and 16
Experimental: 002; placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16	Drug: placebo; Subcutaneous injection at Week 0 and 4; Drug: ustekinumab; 45 mg subcutaneous injection at Week 12 and 16; Drug: placebo; Subcutaneous injection at Week 12; Drug: ustekinumab; 45 mg subcutaneous injection at Week 0, 4 and 16

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

Collaborators and Investigators

• Sponsor: Centocor, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 11, 2013
• Last Update Submitted That Met QC Criteria: October 17, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Chinese; psoriasis; CNTO 1275; Stelara; ustekinumab; asian patients
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: CR016318 (Other Identifier: Centocor); C0743T23 (Other Identifier: Centocor)