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| Descriptive Information Fields | |||||||||
| Brief Title † | A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis | ||||||||
| 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 | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | 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 ] [ Designated as safety issue: No ] | ||||||||
| Condition † | Psoriasis | ||||||||
| Intervention † | Drug: BMS-582949 Drug: Placebo |
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| MEDLINE PMIDs | |||||||||
| Links | BMS Clinical Trials Disclosure  For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 99 | ||||||||
| Start Date † | August 2007 | ||||||||
| Completion Date | May 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Australia, Canada, Mexico | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00399906 | ||||||||
| Organization ID | IM119-013 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Bristol-Myers Squibb | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | November 14, 2006 | ||||||||
| Last Updated Date | November 19, 2008 | ||||||||
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