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

Centocor Ortho Biotech

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: ustekinumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01008995

CR016318 (Other Identifier)

C0743T23 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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322 participants in 2 patient groups

001

Experimental group

Description:

placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16

Treatment:

Drug: ustekinumab

Drug: placebo

Drug: placebo

Drug: ustekinumab

002

Experimental group

Description:

placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16

Treatment:

Drug: ustekinumab

Drug: placebo

Drug: placebo

Drug: ustekinumab