Mepolizumab for Eosinophilic Fasciitis

Mayo Clinic

Status and phase: Withdrawn; Phase 1

Conditions: Eosinophilic Fasciitis

Treatments: Drug: Mepolizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04305678

19-011851

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single Arm

Experimental group

Description:

Patients with a biopsy proven diagnosis of eosinophilic fasciitis

Treatment:

Drug: Mepolizumab