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

• ClinicalTrials.gov Identifier: NCT01008995
• Recruitment Status: Completed
• First Posted: November 6, 2009
• Results First Posted: September 14, 2012
• Last Update Posted: November 11, 2013
• Sponsor: Centocor, Inc.
• Information provided by (Responsible Party): Centocor, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: placebo; Drug: ustekinumab	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 322 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: October 2009
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

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
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 12; Drug: ustekinumab; 45 mg subcutaneous injection at Week 0, 4 and 16

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

China

Beijing, China

Chongqing, China

Dalian, China

Guangzhou, China

Hangzhou, China

Nanjing, China

Shanghai, China

Shenyang, China

Xi'An, China

Sponsors and Collaborators

Centocor, Inc.

Investigators

• Study Director: Centocor, Inc. Clinical Trial; Centocor, Inc.

More Information

• Responsible Party: Centocor, Inc.
• ClinicalTrials.gov Identifier: NCT01008995
• Other Study ID Numbers: CR016318; C0743T23 ( Other Identifier: Centocor ); CR016318 ( Other Identifier: Centocor )
• First Posted: November 6, 2009
• Results First Posted: September 14, 2012
• Last Update Posted: November 11, 2013
• Last Verified: October 2013

Keywords provided by Centocor, Inc.:

psoriasis; asian patients; Chinese; ustekinumab; CNTO 1275; Stelara

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ustekinumab; Dermatologic Agents