Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

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.