NCT00399906
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Psoriasis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
P1
10 or 100 mg
Intervention: Placebo
A1
10 mg
Intervention: BMS-582949
A2
30 mg
Intervention: BMS-582949
A3
100 mg
Intervention: BMS-582949
Outcomes
Primary Outcomes
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
Time Frame: at Week 12
Secondary Outcomes
- Proportion of subjects achieving a PASI-90(at Week 12)
- Proportion of subjects achieving a PASI-75(at Week 12)
- Proportion of subjects achieving a PASI-50(at Week 12)
Study Sites (1)
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