Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Phase 2

Completed

• Conditions: Psoriasis Vulgaris

• Registration Number: NCT00287547
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 1997-03
• Primary Completion: 1998-01
• Study Completion: 1998-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-11
• Disposition First Submitted QC: 2011-04-11
• Last Update Submitted: 2011-04-11
• Disposition First Posted: 2011-04-25
• Last Update Posted: 2011-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• 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 Criteria

• 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Burlington, Vermont, United States