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

NCT ID: NCT00399906

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

10 mg

Group Type ACTIVE_COMPARATOR

BMS-582949

Intervention Type DRUG

Tablets, Oral, Once daily, 12 weeks

A2

30 mg

Group Type ACTIVE_COMPARATOR

BMS-582949

Intervention Type DRUG

Tablets, Oral, Once daily, 12 weeks

A3

100 mg

Group Type ACTIVE_COMPARATOR

BMS-582949

Intervention Type DRUG

Tablets, Oral, Once daily, 12 weeks

P1

10 or 100 mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, Once daily, 12 weeks

Interventions

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BMS-582949

Tablets, Oral, Once daily, 12 weeks

Intervention Type DRUG

Placebo

Tablets, Oral, Once daily, 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Kogarah, New South Wales, Australia

Site Status

Local Institution

Greenslopes, Queensland, Australia

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North Adelaide, South Australia, Australia

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Carlton, Victoria, Australia

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Malvern, Victoria, Australia

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Local Institution

México, Aguascalientes, Mexico

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Local Institution

Zapopan, Jalisco, Mexico

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Local Institution

Df, Mexico City, Mexico

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Local Institution

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Australia Canada Mexico

Related Links

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Other Identifiers

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IM119-013

Identifier Type: -

Identifier Source: org_study_id