Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Psoriasis Vulgaris

Treatments

Drug: CTLA4Ig / Abatacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00287547

IM101-005

Details and patient eligibility

About

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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.)