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

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

U.S. FDA Resources

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

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 ]

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

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

Contacts


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.

Show 22 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More 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

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

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00399906