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OpenTrials
Completed

NCT Number: NCT00063752

Safety Study of PI-0824 to Treat Pemphigus Vulgaris

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PI-0824

Drug

Sponsors and collaborators

Lead sponsor

Peptimmune

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Jul 8, 2003
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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