A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00399906
First received: November 14, 2006
Last updated: February 22, 2011
Last verified: May 2009
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects achieving a PASI-50 [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
- Proportion of subjects achieving a PASI-75 [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
- Proportion of subjects achieving a PASI-90 [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 99 |
| Study Start Date: | August 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A1
10 mg
|
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
|
|
Active Comparator: A2
30 mg
|
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
|
|
Active Comparator: A3
100 mg
|
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
|
|
Placebo Comparator: P1
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 |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399906
Locations
| Australia, New South Wales | |
| Local Institution | |
| Kogarah, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
| Local Institution | |
| Greenslopes, Queensland, Australia, 4120 | |
| Australia, South Australia | |
| Local Institution | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Local Institution | |
| Carlton, Victoria, Australia, 3053 | |
| Local Institution | |
| Malvern, Victoria, Australia, 3144 | |
| Canada, Alberta | |
| Local Institution | |
| Calgary, Alberta, Canada, T3A 2N1 | |
| Local Institution | |
| Edmonton, Alberta, Canada, T5K 1X3 | |
| Canada, British Columbia | |
| Local Institution | |
| Surrey, British Columbia, Canada, V3R 6A7 | |
| Canada, Manitoba | |
| Local Institution | |
| Winnipeg, Manitoba, Canada, R2C 0N2 | |
| Canada, Newfoundland and Labrador | |
| Local Institution | |
| St. John'S, Newfoundland and Labrador, Canada, A1B 3E1 | |
| Canada, Nova Scotia | |
| Local Institution | |
| Halifax, Nova Scotia, Canada, B3H 1Z4 | |
| Canada, Ontario | |
| Local Institution | |
| Oakville, Ontario, Canada, L6J 7W5 | |
| Local Institution | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Local Institution | |
| Waterloo, Ontario, Canada, N2J 1C4 | |
| Canada, Quebec | |
| Local Institution | |
| Montreal, Quebec, Canada, H3H 1V4 | |
| Local Institution | |
| St-Leonard, Quebec, Canada, H1S 3A9 | |
| Canada | |
| Local Institution | |
| Quebec, Canada, G1V 4X7 | |
| Mexico | |
| Local Institution | |
| Mexico, Aguascalientes, Mexico, 20127 | |
| Local Institution | |
| Df, Distrito Federal, Mexico, 06780 | |
| Local Institution | |
| Zapopan, Jalisco, Mexico, 45190 | |
| Local Institution | |
| Monterrey, Nuevo Leon, Mexico, 64060 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00399906 History of Changes |
| Other Study ID Numbers: | IM119-013 |
| Study First Received: | November 14, 2006 |
| Last Updated: | February 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013