Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Completed · Phase 1
Conditions studied: Psoriasis Vulgaris
In brief
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)
Key facts
- Study ID
- NCT00306878
- Run by
- Bristol-Myers Squibb
- People needed
- 45
- Starts
- 1995-08-01
- Expected to finish
- 1997-05-01
- Last updated by the study team
- 2011-04-13
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Local Institution — Boston, Massachusetts, United States
- Local Institution — Ann Arbor, Michigan, United States
- Local Institution — New York, New York, United States
- Local Institution — Philadelphia, Pennsylvania, United States
- Local Institution — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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