Psoriasis, Moderate to Severe Clinical Trial
Official title:
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
| Verified date | September 2007 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution | Boise | Idaho |
| United States | Local Institution | Columbus | Ohio |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution | Fridley | Minnesota |
| United States | Local Institution | Greer | South Carolina |
| United States | Local Institution | Miami Beach | Florida |
| United States | Local Institution | New Brunswick | New Jersey |
| United States | Local Institution | New York | New York |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Phoenix | Arizona |
| United States | Local Institution | Pinellas Park | Florida |
| United States | Local Institution | Portland | Oregon |
| United States | Local Institution | San Diego | California |
| United States | Local Institution | St. Louis | Missouri |
| United States | Local Institution | Tucson | Arizona |
| United States | Local Institution | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | To estimate the proportion of patients achieving a PASI 75 response in each treatment arm. | |||
| Secondary | To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm. | |||
| Secondary | To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm. | |||
| Secondary | To estimate the percent change from baseline in epidermal thickness of psoriatic lesion. | |||
| Secondary | To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis. | |||
| Secondary | To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101 |