Safety Study of PI-0824 to Treat Pemphigus Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Peptimmune
ClinicalTrials.gov Identifier:
NCT00063752
First received: July 3, 2003
Last updated: June 23, 2005
Last verified: April 2005
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: 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

Resource links provided by NLM:


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
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
Peptimmune
  More Information

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on April 15, 2014