Purpose

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


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

Genetics Home Reference related topics:   Autoimmune Diseases   Skin Conditions  

ChemIDplus related topics:   Corticosteroids  

U.S. FDA Resources

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 as provided by Peptimmune:

Estimated Enrollment:   15
Study Start Date:   July 2003
Estimated Study Completion Date:   March 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063752

Locations
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
NYU School of Medicine    
      New York, New York, United States, 10016
Long Island Jewish Medical Center    
      New Hyde Park, New York, United States, 11040
Stony Brook Dermatology Associates    
      East Setauket, New York, United States, 11733
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
Peptimmune
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
NYU School of Medicine    
      New York, New York, United States, 10016
Long Island Jewish Medical Center    
      New Hyde Park, New York, United States, 11040
Stony Brook Dermatology Associates    
      East Setauket, New York, United States, 11733
United States, Ohio
Case Western Reserve University    
      Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania    
      Philadelphia, Pennsylvania, United States, 19104
Peptimmune
  More Information

International Pemphigus Foundation  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   PI-001
First Received:   July 3, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00063752
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Pemphigus vulgaris
Autoimmune Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pemphigus

Additional relevant MeSH terms:
Immune System Diseases
Pemphigus

Source: National Library of Medicine (NLM) July 07, 2008

  


 
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