Clinical Trial: Use of KC706 for the Treatment of Pemphigus Vulgaris

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Open-Label Uncontrolled Pilot Study of KC706 in Patients With Stable, Active Pemphigus Vulgaris

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Kemia, Inc

Current Primary Outcome: To evaluate the ability of KC706 to prevent the appearance of new lesions and heal existing lesions, while maintaining stable doses of corticosteroids and/or immunosuppressants in patients with pemphigus vulgaris. [ Time Frame: 16 weeks ]

Original Primary Outcome: To evaluate the ability of KC706 to prevent the appearance of new lesions and heal existing lesions, while maintaing stable doses of corticosteroids and/or immunosuppressants in patients with pemphigus vulgaris. [ Time Frame: 16 weeks ]

Current Secondary Outcome: Evaluate the safety of KC706 in patients with PV and to assess plasma levels of KC706 with once daily dosing. [ Time Frame: 16 weeks ]

Original Secondary Outcome: Same as current

Information By: Kemia, Inc

Dates:
Date Received: January 22, 2008
Date Started: November 2007
Date Completion:
Last Updated: June 18, 2008
Last Verified: June 2008