NCT00399906

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2007

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 7, 2015

Status Verified

November 1, 2015

Enrollment Period

1.4 years

First QC Date

November 14, 2006

Last Update Submit

November 6, 2015

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

    at Week 12

Secondary Outcomes (3)

  • Proportion of subjects achieving a PASI-50

    at Week 12

  • Proportion of subjects achieving a PASI-75

    at Week 12

  • Proportion of subjects achieving a PASI-90

    at Week 12

Study Arms (4)

A1

ACTIVE COMPARATOR

10 mg

Drug: BMS-582949

A2

ACTIVE COMPARATOR

30 mg

Drug: BMS-582949

A3

ACTIVE COMPARATOR

100 mg

Drug: BMS-582949

P1

PLACEBO COMPARATOR

10 or 100 mg

Drug: Placebo

Interventions

BMS-582949DRUG

Tablets, Oral, Once daily, 12 weeks

A1A2A3
PlaceboDRUG

Tablets, Oral, Once daily, 12 weeks

P1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and Females (not nursing or not pregnant)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Local Institution

Kogarah, New South Wales, 2217, Australia

Location

Local Institution

Greenslopes, Queensland, 4120, Australia

Location

Local Institution

North Adelaide, South Australia, 5006, Australia

Location

Local Institution

Carlton, Victoria, 3053, Australia

Location

Local Institution

Malvern, Victoria, 3144, Australia

Location

Local Institution

Calgary, Alberta, T3A 2N1, Canada

Location

Local Institution

Edmonton, Alberta, T5K 1X3, Canada

Location

Local Institution

Surrey, British Columbia, V3R 6A7, Canada

Location

Local Institution

Winnipeg, Manitoba, R2C 0N2, Canada

Location

Local Institution

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Local Institution

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Local Institution

Oakville, Ontario, L6J 7W5, Canada

Location

Local Institution

Toronto, Ontario, M9W 4L6, Canada

Location

Local Institution

Waterloo, Ontario, N2J 1C4, Canada

Location

Local Institution

Montreal, Quebec, H3H 1V4, Canada

Location

Local Institution

Québec, Quebec, G1V 4X7, Canada

Location

Local Institution

Saint-Léonard, Quebec, H1S 3A9, Canada

Location

Local Institution

México, Aguascalientes, 20127, Mexico

Location

Local Institution

Zapopan, Jalisco, 45190, Mexico

Location

Local Institution

Df, Mexico City, 06780, Mexico

Location

Local Institution

Monterrey, Nuevo León, 64060, Mexico

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamide

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 15, 2006

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

December 7, 2015

Record last verified: 2015-11

Locations

CA(12)AU(5)ME(4)