A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus
Enrollment status: Open
The investigational drug PRN1008 is a Bruton’s tyrosine kinase (BTK) inhibitor. PRN1008 may work within your immune system to block the autoimmune process that leads to pemphigus vulgaris (PV) and pemphigus foliaceus (PF). This study is looking for newly diagnosed or relapsing Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) patients with moderate to severe disease. It is a 9-month, randomized, placebo-controlled study on a background of usual care of prednisolone, with a goal of decreasing corticosteroids after controlled disease. Subjects will receive a tablet of PRN1008 or placebo taken by mouth twice daily. At the end of the 9 months of randomized treatment, all patients on study will receive PRN1008 treatment for 6 months. Clinic visits are approximately monthly, and twice during the first month on study. The total length of the study for each patient is about 17 months.
Study coordinator: Aaron Rankin, (734) 936-7519 or email@example.com
Please reference Derm #: 735