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| Sponsored by: |
Bristol-Myers Squibb |
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00399906 |
Purpose
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.
| Condition | Intervention | Phase |
|
Psoriasis |
Drug: BMS-582949 Drug: Placebo |
Phase I Phase II |
| MedlinePlus related topics: | Psoriasis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A1: Active Comparator
10 mg
|
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
|
|
A2: Active Comparator
30 mg
|
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
|
|
A3: Active Comparator
100 mg
|
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
|
|
P1: Placebo Comparator
10 or 100 mg
|
Drug: Placebo
Tablets, Oral, Once daily, 12 weeks
|
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
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Show 22 Study Locations |
| Bristol-Myers Squibb |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
BMS Clinical Trials Disclosure 
  |
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 
  |
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | IM119-013 |
| First Received: | November 14, 2006 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00399906 |
| Health Authority: | United States: Food and Drug Administration |
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