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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399906
• Other study ID #: IM119-013
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2006
• Last updated: November 6, 2015
• Start date: August 2007
• Est. completion date: April 2009

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-582949
Tablets, Oral, Once daily, 12 weeks
• Placebo
Tablets, Oral, Once daily, 12 weeks

Locations

Country	Name	City	State
Australia	Local Institution	Carlton	Victoria
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Kogarah	New South Wales
Australia	Local Institution	Malvern	Victoria
Australia	Local Institution	North Adelaide	South Australia
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Oakville	Ontario
Canada	Local Institution	Quebec
Canada	Local Institution	St-Leonard	Quebec
Canada	Local Institution	St. John'S	Newfoundland and Labrador
Canada	Local Institution	Surrey	British Columbia
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Waterloo	Ontario
Canada	Local Institution	Winnipeg	Manitoba
Mexico	Local Institution	Df	Distrito Federal
Mexico	Local Institution	Mexico	Aguascalientes
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Zapopan	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12		at Week 12	No
Secondary	Proportion of subjects achieving a PASI-50		at Week 12	No
Secondary	Proportion of subjects achieving a PASI-75		at Week 12	No
Secondary	Proportion of subjects achieving a PASI-90		at Week 12	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form