Study of BMS-587101 in Patients With Moderate to Severe Psoriasis

February 27, 2010 updated by: Bristol-Myers Squibb

Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis

The purpose of this clinical research study is to learn if BMS-587101 is effective on the treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • California
      • San Diego, California, United States
        • Local Institution
    • Florida
      • Miami Beach, Florida, United States
        • Local Institution
      • Pinellas Park, Florida, United States
        • Local Institution
    • Idaho
      • Boise, Idaho, United States
        • Local Institution
    • Minnesota
      • Fridley, Minnesota, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Local Institution
    • Ohio
      • Columbus, Ohio, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Greer, South Carolina, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Otherwise healthy individuals with a diagnosis of plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may be enrolled).

Men and Women Not of Child Bearing Potential (i.e. women who are postmenopausal or surgically sterile), women ages 18 to 75.

-

Exclusion Criteria: Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.

Known or suspected infection, including infection with human immunodeficiency virus (HIV), hepatitis B or C viruses. Any recent infections requiring antibiotic treatment that completed within 4 weeks of enrollment.

Any known malignancy or history of malignancy within 5 years prior to enrollment, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised with no evidence of recurrence (squamous cell carcinoma of other locations is exclusionary).

Any history of Guillane-Barre syndrome. History of keloid formation.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To estimate the clinical response in terms of the percent of subjects achieving PASI_50 in each treatment arm, and to determine whether there was a difference in PASI_50 between each BMS-587101 treatment arm and placebo

Secondary Outcome Measures

Outcome Measure
To estimate the proportion of patients achieving a PASI 75 response in each treatment arm.
To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm.
To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm.
To estimate the percent change from baseline in epidermal thickness of psoriatic lesion.
To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis.
To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM117-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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