Mepolizumab for Eosinophilic Fasciitis

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Eosinophilic Fasciitis

Interventions

MepolizumabDRUG

Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Modified Rodnan Skin Score (mRSS)

Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.

Time frame: 24 weeks

Secondary Outcomes

Localized Scleroderma Skin Severity Index (mLoSSI) score

Mean change before and after treatment. mLoSSI score quantifies disease activity.

Time frame: 24 weeks

Localized Scleroderma Damage Index (LoSDI) score.

Mean change before and after treatment. LoSDI score quantifies disease damage.

Time frame: 24 weeks

Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)

Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).

Time frame: 24 weeks

Physician's Global Assessment of Disease Activity (PhysGA-A)

Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by "inactive" at 0 and "markedly active" at 100.

Time frame: 24 weeks

Physician's Global Assessment of Disease Damage (PhysGA-D)

Mean change before and after treatment. PhysGA-D is a 100-mm analog scale anchored by "no damage" at 0 and "markedly damaged" at 100.

Time frame: 24 weeks.

Dermatology Quality of Life Index (DLQI)

Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life

Data from ClinicalTrials.gov

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