A Phase 2 interventional study of BMS 587101 in Psoriasis, Moderate to Severe, sponsored by Bristol-Myers Squibb. Terminated at 16 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-03-02.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 120 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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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
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
This study is terminated, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.
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