Autoimmune Skin Disease Clinical Studies

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 dermtrials@med.umich.edu
Please reference Derm #: 735

Personalized Medicine through Integration of Immune Phenotypes in Autoimmune Skin Disease

Enrollment status: Contact us for status

We aim to expand our ability to pick the right treatments for patients with diseases such as lupus and psoriasis. To do this, we need to develop a better understanding of how these diseases behave and respond to treatments over time. Through the Taubman Medical Research Institute, we have been granted funds to follow a cohort of patients to better understand the specific skin and immune system abnormalities that cause diseases like lupus or psoriasis. Our study is Personalized Medicine through Integration of Immune Phenotypes in Autoimmune Skin Diseases. We would like you to consider joining our cohort. This will mean that you will have a research visit after most of your regularly scheduled clinic visits during which we will collect information such as pain and fatigue levels, medication changes, and disease activity. We will also ask for a blood sample at every visit and occasionally a skin biopsy to study the skin responses (but not at every visit). We will use this information to map out your immune responses and how the medications change them in relation to your clinical improvement. You will be compensated for your time for each research visit.

Study coordinator: Rewaa Yas, (734) 936-3889 or rewaay@med.umich.edu
Please reference Tiip study