Safety Study of PI-0824 to Treat Pemphigus Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00063752
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : June 24, 2005
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Brief Summary:
The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.

Condition or disease Intervention/treatment Phase
Pemphigus Vulgaris Drug: PI-0824 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2003
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00063752

United States, California
University of California San Francisco
San Francisco, California, United States, 94107
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
East Coast Clinical Research
Salisbury, Massachusetts, United States, 01952
United States, New York
Stony Brook Dermatology Associates
East Setauket, New York, United States, 11733
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
NYU School of Medicine
New York, New York, United States, 10016
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators

Additional Information: Identifier: NCT00063752     History of Changes
Other Study ID Numbers: PI-001
First Posted: July 8, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2005

Additional relevant MeSH terms:
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases