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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BMS-582949

Placebo

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

10 mg

30 mg

100 mg

10 or 100 mg

Outcomes

Primary Outcome Measures

The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12

Secondary Outcome Measures

Proportion of subjects achieving a PASI-50

Proportion of subjects achieving a PASI-75

Proportion of subjects achieving a PASI-90

Full Information

NCT ID

NCT00399906

First Posted

November 14, 2006

Last Updated

November 6, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00399906

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

10 mg

Arm Title

Arm Type

Active Comparator

Arm Description

30 mg

Arm Title

Arm Type

Active Comparator

Arm Description

100 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

10 or 100 mg

Intervention Type

Drug

Intervention Name(s)

BMS-582949

Intervention Description

Tablets, Oral, Once daily, 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablets, Oral, Once daily, 12 weeks

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Proportion of subjects achieving a PASI-50

Time Frame

at Week 12

Title

Proportion of subjects achieving a PASI-75

Time Frame

at Week 12

Title

Proportion of subjects achieving a PASI-90

Time Frame

at Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Local Institution

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

Local Institution

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Local Institution

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Local Institution

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Local Institution

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3A 2N1

Country

Canada

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

Local Institution

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Local Institution

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2C 0N2

Country

Canada

Facility Name

Local Institution

City

St. John'S

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3E1

Country

Canada

Facility Name

Local Institution

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1Z4

Country

Canada

Facility Name

Local Institution

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6J 7W5

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Local Institution

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1V4

Country

Canada

Facility Name

Local Institution

City

St-Leonard

State/Province

Quebec

ZIP/Postal Code

H1S 3A9

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

Local Institution

City

Mexico

State/Province

Aguascalientes

ZIP/Postal Code

20127

Country

Mexico

Facility Name

Local Institution

City

State/Province

Distrito Federal

ZIP/Postal Code

06780

Country

Mexico

Facility Name

Local Institution

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45190

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64060

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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

Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial