Safety Study of PI-0824 to Treat Pemphigus Vulgaris

Pemphigus Vulgaris Clinical Trial

Official title:

An Open-Label, Dose-Escalation, Phase I Clinical Study to Assess the Safety of PI-0824 in Patient With Pemphigus Vulgaris Requiring Daily Corticosteroid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063752
• Other study ID #: PI-001
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2003
• Last updated: June 23, 2005
• Start date: July 2003
• Est. completion date: March 2005

Study information

• Verified date: April 2005
• Source: Peptimmune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pemphigus
• Pemphigus Vulgaris

Intervention

Drug:
• PI-0824

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Case Western Reserve University	Cleveland	Ohio
United States	Stony Brook Dermatology Associates	East Setauket	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	NYU School of Medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	East Coast Clinical Research	Salisbury	Massachusetts
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Peptimmune

Country where clinical trial is conducted

United States, 

External Links

•   International Pemphigus Foundation