Psoriasis
Conditions
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.
Interventions
DRUGBMS-582949
Tablets, Oral, Once daily, 12 weeks
DRUGPlacebo
Tablets, Oral, Once daily, 12 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12 | at Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a PASI-50 | at Week 12 |
| Proportion of subjects achieving a PASI-75 | at Week 12 |
| Proportion of subjects achieving a PASI-90 | at Week 12 |
Countries
Australia, Canada, Mexico
Outcome results
None listed