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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00063752
Other study ID # PI-001
Secondary ID
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
Est. primary completion date
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


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, 

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