Safety Study of PI-0824 to Treat Pemphigus Vulgaris
Primary Purpose
Pemphigus Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PI-0824
Sponsored by
About this trial
This is an interventional treatment trial for Pemphigus Vulgaris
Eligibility Criteria
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.
Sites / Locations
- University of California San Francisco
- Johns Hopkins School of Medicine
- East Coast Clinical Research
- Stony Brook Dermatology Associates
- Long Island Jewish Medical Center
- NYU School of Medicine
- Case Western Reserve University
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00063752
Brief Title
Safety Study of PI-0824 to Treat Pemphigus Vulgaris
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 Type
Interventional
2. Study Status
Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Peptimmune
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pemphigus Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PI-0824
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
East Coast Clinical Research
City
Salisbury
State/Province
Massachusetts
ZIP/Postal Code
01952
Country
United States
Facility Name
Stony Brook Dermatology Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.pemphigus.org
Description
International Pemphigus Foundation
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Safety Study of PI-0824 to Treat Pemphigus Vulgaris
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