Psoriasis Vulgaris
Conditions
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
Interventions
DRUGCTLA4Ig / Abatacept
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed