Psoriasis Vulgaris
Conditions
Brief summary
The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)
Interventions
DRUGAbatacept
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures. * Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration. * Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score \[ODSS\]of 4-7 inclusive). * Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate.
Exclusion criteria
* Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment. * No clinical response to a prior adequate therapeutic trial of cyclosporin A * Prolonged exposure to the sun within 4 weeks prior to the first dose. * Guttate, erythrodermic, or pustular psoriasis. * Spontaneously improving or rapidly deteriorating psoriasis vulgaris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer | at Day 43 |
Secondary
| Measure | Time frame |
|---|---|
| Physician's globas Assessment | at Day 36 |
| Phage-neutralizing antibody titer | at Day 16 and Day 29 |
| Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected | at Day 43 |
Countries
United States
Outcome results
None listed