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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00399906




Registration number
NCT00399906
Ethics application status
Date submitted
14/11/2006
Date registered
15/11/2006
Date last updated
7/12/2015

Titles & IDs
Public title
A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis
Scientific 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
Secondary ID [1] 0 0
IM119-013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-582949
Treatment: Drugs - Placebo

Active Comparator: A1 - 10 mg

Active Comparator: A2 - 30 mg

Active Comparator: A3 - 100 mg

Placebo Comparator: P1 - 10 or 100 mg


Treatment: Drugs: BMS-582949
Tablets, Oral, Once daily, 12 weeks

Treatment: Drugs: Placebo
Tablets, Oral, Once daily, 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
Timepoint [1] 0 0
at Week 12
Secondary outcome [1] 0 0
Proportion of subjects achieving a PASI-50
Timepoint [1] 0 0
at Week 12
Secondary outcome [2] 0 0
Proportion of subjects achieving a PASI-75
Timepoint [2] 0 0
at Week 12
Secondary outcome [3] 0 0
Proportion of subjects achieving a PASI-90
Timepoint [3] 0 0
at Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - Greenslopes
Recruitment hospital [3] 0 0
Local Institution - North Adelaide
Recruitment hospital [4] 0 0
Local Institution - Carlton
Recruitment hospital [5] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Mexico
State/province [8] 0 0
Aguascalientes
Country [9] 0 0
Mexico
State/province [9] 0 0
Distrito Federal
Country [10] 0 0
Mexico
State/province [10] 0 0
Jalisco
Country [11] 0 0
Mexico
State/province [11] 0 0
Nuevo Leon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00399906
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00399906