Mepolizumab for Eosinophilic Fasciitis

Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study

This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.

This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.

Inclusion Criteria:

• Male and female patients 18 years or older.
• History and physical examination consistent with EF
• Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
• Documented peripheral eosinophilia (≥500 microliter)
• Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
• Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

• Eosinophilic fascitis disease duration > 5 years
• Known history of adverse reaction to mepolizumab (Nucala)
• Pregnant females
• Females actively trying to conceive
• Vulnerable study population
• Asthma requiring inhaled cortiosteroids