NCT00063752

Safety Study of PI-0824 to Treat Pemphigus Vulgaris

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: Peptimmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pemphigus Vulgaris

Interventions

Type	Name	Description
DRUG	PI-0824

Timeline

• Start date: 2003-07-01
• Completion: 2005-03-01
• First posted: 2003-07-08
• Last updated: 2005-06-24

Locations

8 sites across 1 country: United States