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Completed

NCT Number: NCT01008995

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Subcutaneous injection at Week 0 and 4

Ustekinumab

Drug

45 mg subcutaneous injection at Week 12 and 16

Primary outcomes

  1. The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.

    Time frame: Baseline (Week 0) to Week 12

    Scores could range from 0 (mild) to 72 (severe).

Secondary outcomes

  1. 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

  2. The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.

    Time frame: Baseline (Week 0) to Week 12

    Scores could range from 0 to 30. A lower DLQI score represents better quality of life.

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 6, 2009
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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