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.
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Notify MeKey information
Conditions
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
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
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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