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The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.
Pemphigus Vulgaris
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Drug: PI-0824
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Phase I
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study |
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| 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 |
| Estimated Enrollment: |
15 |
| Study Start Date: |
July 2003 |
| Estimated Study Completion Date: |
March 2005 |
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.
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063752
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| University of California San Francisco |
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| San Francisco, California, United States, 94107 |
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| Johns Hopkins School of Medicine |
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| Baltimore, Maryland, United States, 21205 |
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| East Coast Clinical Research |
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| Salisbury, Massachusetts, United States, 01952 |
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| NYU School of Medicine |
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| New York, New York, United States, 10016 |
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| Long Island Jewish Medical Center |
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| New Hyde Park, New York, United States, 11040 |
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| Stony Brook Dermatology Associates |
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| East Setauket, New York, United States, 11733 |
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| Case Western Reserve University |
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| Cleveland, Ohio, United States, 44106 |
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| University of Pennsylvania |
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| Philadelphia, Pennsylvania, United States, 19104 |
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| University of California San Francisco |
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| San Francisco, California, United States, 94107 |
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| Johns Hopkins School of Medicine |
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| Baltimore, Maryland, United States, 21205 |
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| East Coast Clinical Research |
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| Salisbury, Massachusetts, United States, 01952 |
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| NYU School of Medicine |
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| New York, New York, United States, 10016 |
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| Long Island Jewish Medical Center |
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| New Hyde Park, New York, United States, 11040 |
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| Stony Brook Dermatology Associates |
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| East Setauket, New York, United States, 11733 |
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| Case Western Reserve University |
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| Cleveland, Ohio, United States, 44106 |
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| University of Pennsylvania |
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| Philadelphia, Pennsylvania, United States, 19104 |
| 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 | |
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