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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Psoriasis Vulgaris

Treatments

Drug: Abatacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00306878

IM101-001

Details and patient eligibility

About

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)

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.