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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

September 9, 2005
February 27, 2010
April 2005
June 2006   (final data collection date for primary outcome 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
Same as current
Complete list of historical versions of study NCT00162253 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis, Moderate to Severe
Drug: BMS 587101
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
Not Provided
June 2006   (final data collection date for primary outcome measure)

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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Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162253
IM117-005
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP