Clinical trial NCT00162253: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriasis, Moderate to Severe
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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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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Primary outcomes:
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 outcomes:
measure: To estimate the proportion of patients achieving a PASI 75 response in each treatment arm.
measure: To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm.
measure: To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm.
measure: To estimate the percent change from baseline in epidermal thickness of psoriatic lesion.
measure: To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis.
measure: To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Tucson
country: United States
facility: Local Institution
state: Arizona
city: San Diego
country: United States
facility: Local Institution
state: California
city: Miami Beach
country: United States
facility: Local Institution
state: Florida
city: Pinellas Park
country: United States
facility: Local Institution
state: Florida
city: Boise
country: United States
facility: Local Institution
state: Idaho
city: Fridley
country: United States
facility: Local Institution
state: Minnesota
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: New York
country: United States
facility: Local Institution
state: New York
city: Winston-Salem
country: United States
facility: Local Institution
state: North Carolina
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Greer
country: United States
facility: Local Institution
state: South Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
Study officials:
References: