The purpose of this trial is to (a) determine the ability of KC706 to prevent the appearance of new blisters and heal existing blisters, while maintaining stable doses of corticosteroids and/or immunosuppressants, in patients with pemphigus vulgaris (b) to determine the safety of KC706 and (c) to access the plasma levels of KC706.
This study, sponsored by Kemia, Inc., has been completed.
KC706 is a new class of agent that could offer hope to patients in healing and preventing pemphigus lesions. Patients with PV have antibodies directed against proteins called desmogliens, which serve as a “glue” between the layers of skin. The study will assess the effects of the experimental drug KC706 to interrupt the activity of these antibodies, thereby preventing the skin from forming blisters.
Current treatments have multiple side effects therefore there is a high unmet medical need for treatments with fewer side effects. Dr. Rubinstein’s, from UNC Chapel Hill has developed an animal model of pemphigus vulgaris. When used in this animal model, KC706 prevented the occurrence of blistering.
Patients must be at least 18 years of age, with active PV skin, scalp or mucosal lesions and a diagnosis of pemphigus vulgaris confirmed by skin lesion biopsy. The patients must be taking and require either stable doses of corticosteroid therapy or immunosuppressive therapy or both. Pregnant or nursing women are not eligible to participate in the trial. All potential participants will have a screening visit which will include a review of their medical history, and a blood draw to determine their eligibility to participate in the study.
3 months of treatment, assessments of efficacy and tolerability every two weeks, with a four week follow-up.
If you are interested in participating in this trial or referring a patient, please contact:
University of Pennsylvania
Principal Investigator: Victoria Werth, M.D.
Joyce Okawa, R. N.
215-898-0168 or [email protected]
215-898-0108 or [email protected]
New York University School of Medicine
Principal Investigator: Bruce Strober, M.D. Ph.D.
Elizabeth Camacho or [email protected]
Florida Academic Dermatology Centers-Cedars Medical Center
Principal Investigator: Francisco Kerdel M.D.
305-324-2110 or [email protected]
Harbor UCLA Medical Center
Principal Investigator: Michael Kolodney, MD
Rattapon Thuangtong, MD
310-222-1845 or [email protected]
University Hospitals Case Medical Center
Principal Investigator: Neil Korman, M.D.
216-983-0861 or [email protected]
University of Texas-Southwestern Medical Center
Principal Investigator: Amit Pandya, MD
Christina Carrigan, R. N.
214-645-8968 or [email protected]
University of North Carolina- Chapel Hill
Principal Investigator: David Rubenstein, M.D. Ph.D.
919-966-1406 or [email protected]