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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00399906
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : December 7, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-582949 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A1
10 mg
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
Active Comparator: A2
30 mg
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
Active Comparator: A3
100 mg
Drug: BMS-582949
Tablets, Oral, Once daily, 12 weeks
Placebo Comparator: P1
10 or 100 mg
Drug: Placebo
Tablets, Oral, Once daily, 12 weeks

Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of subjects achieving a PASI-50 [ Time Frame: at Week 12 ]
  2. Proportion of subjects achieving a PASI-75 [ Time Frame: at Week 12 ]
  3. Proportion of subjects achieving a PASI-90 [ Time Frame: at Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00399906

Australia, New South Wales
Local Institution
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Local Institution
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Local Institution
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Local Institution
Carlton, Victoria, Australia, 3053
Local Institution
Malvern, Victoria, Australia, 3144
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T3A 2N1
Local Institution
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Local Institution
Surrey, British Columbia, Canada, V3R 6A7
Canada, Manitoba
Local Institution
Winnipeg, Manitoba, Canada, R2C 0N2
Canada, Newfoundland and Labrador
Local Institution
St. John'S, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Local Institution
Oakville, Ontario, Canada, L6J 7W5
Local Institution
Toronto, Ontario, Canada, M9W 4L6
Local Institution
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3H 1V4
Local Institution
St-Leonard, Quebec, Canada, H1S 3A9
Local Institution
Quebec, Canada, G1V 4X7
Local Institution
Mexico, Aguascalientes, Mexico, 20127
Local Institution
Df, Distrito Federal, Mexico, 06780
Local Institution
Zapopan, Jalisco, Mexico, 45190
Local Institution
Monterrey, Nuevo Leon, Mexico, 64060
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00399906     History of Changes
Other Study ID Numbers: IM119-013
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases