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#
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