Clinical trial NCT00399906: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
timeFrame: at Week 12
Secondary outcomes:
measure: Proportion of subjects achieving a PASI-50
timeFrame: at Week 12
measure: Proportion of subjects achieving a PASI-75
timeFrame: at Week 12
measure: Proportion of subjects achieving a PASI-90
timeFrame: at Week 12
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: North Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Carlton
country: Australia
facility: Local Institution
state: Victoria
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Surrey
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: St. John'S
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Oakville
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Waterloo
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: St-Leonard
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Aguascalientes
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: