Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
1 other identifier
interventional
144
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 1997
Shorter than P25 for phase_2
10 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
March 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedApril 25, 2011
April 1, 2011
10 months
February 6, 2006
April 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.
Secondary Outcomes (1)
Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Local Institution
San Diego, California, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Ann Arbor, Michigan, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Portland, Oregon, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Dallas, Texas, United States
Local Institution
Salt Lake City, Utah, United States
Local Institution
Burlington, Vermont, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
March 1, 1997
Primary Completion
January 1, 1998
Study Completion
January 1, 1998
Last Updated
April 25, 2011
Record last verified: 2011-04