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

Primary Purpose

Psoriasis, Moderate to Severe

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BMS 587101
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis, Moderate to Severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

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Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00162253
Brief Title
Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
Official Title
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Moderate to Severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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. - 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. -
Facility Information:
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
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City
Miami Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Pinellas Park
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Local Institution
City
Fridley
State/Province
Minnesota
Country
United States
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Local Institution
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Local Institution
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New Brunswick
State/Province
New Jersey
Country
United States
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Local Institution
City
New York
State/Province
New York
Country
United States
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Local Institution
City
Winston-Salem
State/Province
North Carolina
Country
United States
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Local Institution
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Columbus
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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