Safety Study of PI-0824 to Treat Pemphigus Vulgaris

June 23, 2005 updated by: Peptimmune

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peptimmune

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

July 3, 2003

First Submitted That Met QC Criteria

July 7, 2003

First Posted (Estimate)

July 8, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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