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OpenTrials
Completed

NCT Number: NCT00399906

A Study of BMS-582949 in Patients 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-582949

Drug

Tablets, Oral, Once daily, 12 weeks

Placebo

Drug

Tablets, Oral, Once daily, 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 15, 2006
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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