Back to resultsPhase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTLA4Ig / Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria: Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration. vulgaris total body surfae area involvement of at least 10% Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate. Exclusion Criteria: Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study. Functional class (V (ACR) RA or amyloidosis) Active vasculitis (except for subcutaneous rheumatoid nodules). Subjects with a history of asthma, angioedema or anaphylaxis. Subjects with evidence of active or latent bacterial or viral invedtions. Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma). body weight > 100 kg (or 220 lbs.)
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Outcomes
Primary Outcome Measures
Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.
Secondary Outcome Measures
Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00287547
Brief Title
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Official Title
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
January 1998 (Actual)
Study Completion Date
January 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
144 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CTLA4Ig / Abatacept
Primary Outcome Measure Information:
Title
Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.
Secondary Outcome Measure Information:
Title
Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.
vulgaris total body surfae area involvement of at least 10%
Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.
Exclusion Criteria:
Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.
Functional class (V (ACR) RA or amyloidosis)
Active vasculitis (except for subcutaneous rheumatoid nodules).
Subjects with a history of asthma, angioedema or anaphylaxis.
Subjects with evidence of active or latent bacterial or viral invedtions.
Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).
body weight > 100 kg (or 220 lbs.)
Facility Information:
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Local Institution
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Salt LAke City
State/Province
Utah
Country
United States
Facility Name
Local Institution
City
Burlington
State/Province
Vermont
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
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