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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162253
Recruitment Status : Terminated
First Posted : September 13, 2005
Last Update Posted : March 2, 2010
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis, Moderate to Severe Drug: BMS 587101 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
Study Start Date : April 2005
Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. To estimate the proportion of patients achieving a PASI 75 response in each treatment arm.
  2. To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm.
  3. To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm.
  4. To estimate the percent change from baseline in epidermal thickness of psoriatic lesion.
  5. To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis.
  6. To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162253

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

Additional Information: Identifier: NCT00162253     History of Changes
Other Study ID Numbers: IM117-005
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: September 2007

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases