Status:
COMPLETED
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 1995
Trial Type :
INTERVENTIONAL
End Date :
May 1 1997
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00306878
Start Date
August 1 1995
End Date
May 1 1997
Last Update
April 13 2011
Active Locations (5)
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1
Local Institution
Boston, Massachusetts, United States
2
Local Institution
Ann Arbor, Michigan, United States
3
Local Institution
New York, New York, United States
4
Local Institution
Philadelphia, Pennsylvania, United States