Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

NCT ID: NCT00306878

Last Updated: 2011-04-13

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

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Study Completion Date

1997-05-31

Brief Summary

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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)

Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Abatacept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Boston, Massachusetts, United States

Site Status

Local Institution

Ann Arbor, Michigan, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

Philadelphia, Pennsylvania, United States

Site Status

Local Institution

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IM101-001

Identifier Type: -

Identifier Source: org_study_id

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