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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162253
First received: September 9, 2005
Last updated: February 27, 2010
Last verified: September 2007
  Purpose

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 Intervention Phase
Psoriasis, Moderate to Severe
Drug: BMS 587101
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 120
Study Start Date: April 2005
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162253

Locations
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00162253     History of Changes
Other Study ID Numbers: IM117-005
Study First Received: September 9, 2005
Last Updated: February 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 14, 2014