A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Measures:

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 ]

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
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

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
Local Institution
Quebec, Canada, G1V 4X7
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T3A 2N1
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R2C 0N2
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Local Institution
Oakville, Ontario, Canada, L6J 7W5
Canada, Quebec
Local Institution
St-Leonard, Quebec, Canada, H1S 3A9
Mexico, Aguascalientes
Local Institution
Mexico, Aguascalientes, Mexico, 20127
Mexico, Distrito Federal
Local Institution
Df, Distrito Federal, Mexico, 06780
Mexico, Jalisco
Local Institution
Zapopan, Jalisco, Mexico, 45190
Mexico, Nuevo Leon
Local Institution
Monterrey, Nuevo Leon, Mexico, 64060

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM119-013
Study First Received:	November 14, 2006
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00399906 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on July 02, 2009