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

Centocor, Inc.322 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

322

Conditions

Psoriasis

Interventions

placeboDRUG

Subcutaneous injection at Week 0 and 4

ustekinumabDRUG

45 mg subcutaneous injection at Week 12 and 16

placeboDRUG

Subcutaneous injection at Week 12

ustekinumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Beijing, China

Unnamed facility

Chongqing, China

Unnamed facility

Dalian, China

Unnamed facility

Guangzhou, China

Outcomes

Primary Outcomes

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).

Time frame: Baseline (Week 0) to Week 12

Secondary Outcomes

The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

Time frame: 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.

Time frame: Baseline (Week 0) to Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.