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Safety Study of PI-0824 to Treat Pemphigus Vulgaris

NCT ID: NCT00063752

Last Updated: 2005-06-24

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-03-31

Brief Summary

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The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.

Detailed Description

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Pemphigus vulgaris (PV) is an autoimmune disease affecting approximately 40,000 people worldwide. People with PV produce antibodies that attack the cells of the skin, resulting in blisters which, if left untreated, can lead to devastating infections and discomfort. Currently, most doctors who treat patients with PV will prescribe high-dose steroids and drugs that suppress the immune system in an effort to decrease the production of these antibodies. Unfortunately these medications are associated with serious and difficult side effects that often result in the discontinuation of their use. Peptimmune, Inc. has developed a new therapy for the treatment of PV, PI-0824. The goal of this therapy is to reduce the production of antibodies that cause PV blisters by acting only on the disease causing components of the immune system. It is hoped that use of PI-0824 will reduce or potentially eliminate the need for high dose steroids and drugs that suppress the immune system.

Conditions

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Pemphigus Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PI-0824

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peptimmune

INDUSTRY

Sponsor Role lead

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status

East Coast Clinical Research

Salisbury, Massachusetts, United States

Site Status

Stony Brook Dermatology Associates

East Setauket, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

NYU School of Medicine

New York, New York, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.pemphigus.org

International Pemphigus Foundation

Other Identifiers

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PI-001

Identifier Type: -

Identifier Source: org_study_id