Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
1 other identifier
interventional
45
1 country
5
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 range of BMS188667 (CTLA4Ig)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 1995
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
March 23, 2006
CompletedFirst Posted
Study publicly available on registry
March 27, 2006
CompletedApril 13, 2011
April 1, 2011
1.8 years
March 23, 2006
April 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer
at Day 43
Secondary Outcomes (3)
Physician's globas Assessment
at Day 36
Phage-neutralizing antibody titer
at Day 16 and Day 29
Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected
at Day 43
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 23, 2006
First Posted
March 27, 2006
Study Start
August 1, 1995
Primary Completion
May 1, 1997
Study Completion
May 1, 1997
Last Updated
April 13, 2011
Record last verified: 2011-04