A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo - Controlled Period (CP) — DRUG
  Placebo, Weeks 0-12
• Ustekinumab 45 mg - CP — DRUG
  Ustekinumab 45 mg, Weeks 0-12
• Placebo to ustekinumab 45 mg - after CP — DRUG
  Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16
• Ustekinumab 45 mg - after CP — DRUG
  Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16

Study Details

The purpose of this study is to evaluate the efficacy and safety of Ustekinumab in the treatment of patients with moderate to severe psoriasis in South Korea and Taiwan.

Key Dates

Start date

Dec 31, 2008

Status verified

Mar 2013

Primary completion

Sep 30, 2009

Completion

Mar 31, 2010

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo - Controlled Period (CP)
• Experimental: Ustekinumab 45 mg - CP
• Experimental: Placebo to ustekinumab 45 mg - after CP
• Experimental: Ustekinumab 45 mg - after CP

Primary Outcome Measure

The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12 [ Time Frame: Week 12 ]

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