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Phase II Randomized, Double-B...

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

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

1998-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CTLA4Ig / Abatacept

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers