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Purpose

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

Condition	Treatment or Intervention	Phase
Pemphigus Vulgaris	Drug: PI-0824	Phase I

related topics: ;

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study

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

Further Study Details:

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.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

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

Expected Total Enrollment: 15

Location and Contact Information

California
University of California San Francisco, San Francisco, California, 94107, United States; Recruiting
Christine Antolos 415-502-6229
M. Kari Connolly, MD, Principal Investigator

Maryland
Johns Hopkins School of Medicine, Baltimore, Maryland, 21205, United States; Recruiting
Anita Guidos, RN 410-955-3422
Grant Anhalt, MD, Principal Investigator

New York
NYU School of Medicine, New York, New York, 10016, United States; Recruiting
Bruce Strober, MD 212-263-5244
Lorrie Jondreau, RN 212-263-5244
Bruce Strober, MD, PhD, Principal Investigator

Ohio
Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting
Zsa Zsa Porter 216-844-5899
Neil Korman, MD, PhD, Principal Investigator

More Information

International Pemphigus Foundation

Study ID Numbers PI-001
Study Start Date July 2003
Record last reviewed September 2003
NLM Identifier
ClinicalTrials.gov processed this record on 2003-11-06