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A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

NCT01550744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2017-02-09

Study results available
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Summary

The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.

Conditions

Interventions

DRUG

Ustekinumab 45 mg

Form = Injection, route = subcutaneous

DRUG

Ustekinumab 90 mg

Form = Injection, route = subcutaneous

DRUG

Placebo

Form = Injection, route = subcutaneous

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Biotech, Inc. Clinical Trial · Janssen Biotech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01550744 on ClinicalTrials.gov