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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

NCT00747344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2013-03-29

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Placebo - Controlled Period (CP)

Placebo, Weeks 0-12

DRUG

Ustekinumab 45 mg - CP

Ustekinumab 45 mg, Weeks 0-12

DRUG

Placebo to ustekinumab 45 mg - after CP

Placebo at Weeks 0 and 4, then ustekinumab 45 mg at Week 12 and Week 16

DRUG

Ustekinumab 45 mg - after CP

Ustekinumab 45 mg at Weeks 0 and 4, then placebo at Week 12 and ustekinumab 45 mg at Week 16

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00747344 on ClinicalTrials.gov