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

November 6, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving a PASI-50
Time Frame: at Week 12
at Week 12
Proportion of subjects achieving a PASI-75
Time Frame: at Week 12
at Week 12
Proportion of subjects achieving a PASI-90
Time Frame: at Week 12
at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (Estimate)

November 15, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM119-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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