Status:
COMPLETED
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
March 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 1998
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00287547
Start Date
March 1 1997
End Date
January 1 1998
Last Update
April 25 2011
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
San Diego, California, United States
2
Local Institution
Chicago, Illinois, United States
3
Local Institution
Boston, Massachusetts, United States
4
Local Institution
Ann Arbor, Michigan, United States