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Sponsored by: |
Kemia, Inc |
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Information provided by: | Kemia, Inc |
ClinicalTrials.gov Identifier: | NCT00606749 |
The purpose of this study is to determine whether KC706 is effective in the prevention and healing of blisters in patients with pemphigus vulgaris, while the patient remains on stable doses of corticosteroids and/or immunosuppressants.
Condition | Intervention | Phase |
---|---|---|
Pemphigus Vulgaris |
Drug: KC706 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase 2 Open-Label Uncontrolled Pilot Study of KC706 in Patients With Stable, Active Pemphigus Vulgaris |
Estimated Enrollment: | 20 |
Study Start Date: | November 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
The present study is designed to follow-up on pre-clinical observations that administration of KC706 is associated with prevention of the development of lesions in a mouse model of PV. Patients participating in this study will be those with active disease in spite of ongoing treatment with corticosteroids and/or immunosuppressive agents. The dose chosen for this clinical study is 300 mg once daily. The primary assessment of interest will be pemphigus lesion status during dosing with KC706.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients should have active PV skin, scalp or mucosal lesions that meet at least one of the following criteria at the Baseline Visit:
Exclusion Criteria:
Clinically significant concurrent medical disease or laboratory abnormalities evidenced by one or more of the following:
United States, Pennsylvania | |
Victoria Werth, MD | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Victoria Werth, MD | University of Pennsylvania |
Principal Investigator: | Bruce Strober, MD | NYU MEDICAL CENTER |
Principal Investigator: | Francisco Kerdel, MD | Florida Academic Dermatology Centers |
Principal Investigator: | Michael Kolodney, MD | University of California, Los Angeles |
Principal Investigator: | Neil Korman, MD | University Hospitals Case Medical Center |
Principal Investigator: | Amit Pandya, MD | University of Texas Southwestern Medical Center |
Principal Investigator: | David Rubenstein, MD, PhD | The University of North Carolina, Chapel Hill |
Responsible Party: | Kemia,Inc ( Michael R Hodges, MD ) |
Study ID Numbers: | KC706-C08 |
Study First Received: | January 22, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00606749 |
Health Authority: | United States: Food and Drug Administration |
Pemphigus vulgaris Autoimmune Diseases Skin Diseases, Vesiculobullous Skin Diseases Pemphigus |
Immune System Diseases |