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

Tracking Information

First Received Date ^ICMJE

November 14, 2006

Last Updated Date

November 16, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 after 12 weeks of treatment

Change History

Complete list of historical versions of study NCT00399906 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

The proportion of subjects who achieve a Static Physician's Global Assessment of "clear" or "minimal", PASI-75 response and PASI-90 response at 12 weeks of treatment

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: BMS-582949
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: 10 mg
Active Comparator: 30 mg
Active Comparator: 100 mg
Placebo Comparator: 10 or 100 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada, Mexico

Administrative Information

NCT ID ^ICMJE

NCT00399906

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

IM119-013

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP