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Safety Study of PI-0824 to Treat Pemphigus Vulgaris

Sponsor
Peptimmune (Industry)
Overall Status
Completed
CT.gov ID
NCT00063752
Collaborator
(none)
15
Enrollment
8
Locations
20
Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Jul 1, 2003
Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94107
    2 Johns Hopkins School of Medicine Baltimore Maryland United States 21205
    3 East Coast Clinical Research Salisbury Massachusetts United States 01952
    4 Stony Brook Dermatology Associates East Setauket New York United States 11733
    5 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    6 NYU School of Medicine New York New York United States 10016
    7 Case Western Reserve University Cleveland Ohio United States 44106
    8 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Peptimmune

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00063752
    Other Study ID Numbers:
    • PI-001
    First Posted:
    Jul 8, 2003
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Apr 1, 2005
    Additional relevant MeSH terms:
    Pemphigus

    Study Results

    No Results Posted as of Jun 24, 2005