The purpose of this clinical research study is to learn if BMS-582949 alone is an effective treatment for moderate to severe psoriasis. The safety of the drug and the effectiveness of each dose will also be studied.

Official Title

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Pharmacokinetics of Three Different Doses of BMS-582949 Given Orally to Subjects With Moderate to Severe Plaque Psoriasis

Conditions

Psoriasis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • A comparison of the proportion of subjects achieving a 50% reduction in their Psoriasis Area and Severity Index (PASI-50) between each BMS-582949 treatment arm and placebo [Time Frame: after 12 weeks of treatment]

Secondary Outcome Measures:

  • The proportion of subjects who achieve a Static Physician’s Global Assessment of “clear” or “minimal”, PASI-75 response and PASI-90 response [Time Frame: at 12 weeks of treatment]

Study Start

August 2007

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years – 75 Years
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Males and Females (not nursing or not pregnant)
  • 18-75 years of age
  • Diagnosis of moderate to severe psoriasis for at least six months at the time of screening
  • Subjects will require wash-out of certain therapies for the treatment of psoriasis but will be allowed to continue on certain topical therapies

Total Enrolment

100

Contact Details

Australian Locations:

  • Kogarah, New South Wales, 2217, Australia; Site 033
  • Fitzroy, Victoria, 3065, Australia; Site 034

For site information, please email: Clinical.Trials@bms.comFirst line of email MUST contain “NCT00399906” & Site#