Mepolizumab for Eosinophilic Fasciitis

Overview

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

Full Title of Study: “Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Single Arm
    • Patients with a biopsy proven diagnosis of eosinophilic fasciitis

Clinical Trial Outcome Measures

Primary Measures

  • Modified Rodnan Skin Score (mRSS)
    • Time Frame: 24 weeks
    • Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.

Secondary Measures

  • Localized Scleroderma Skin Severity Index (mLoSSI) score
    • Time Frame: 24 weeks
    • Mean change before and after treatment. mLoSSI score quantifies disease activity.
  • Localized Scleroderma Damage Index (LoSDI) score.
    • Time Frame: 24 weeks
    • Mean change before and after treatment. LoSDI score quantifies disease damage.
  • Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
    • Time Frame: 24 weeks
    • Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).
  • Physician’s Global Assessment of Disease Activity (PhysGA-A)
    • Time Frame: 24 weeks
    • Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by “inactive” at 0 and “markedly active” at 100.
  • Physician’s Global Assessment of Disease Damage (PhysGA-D)
    • Time Frame: 24 weeks.
    • 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.
  • Dermatology Quality of Life Index (DLQI)
    • Time Frame: 24 weeks.
    • Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life
  • Patient Global Assessment of Disease Severity (PtGA-S)
    • Time Frame: 24 weeks.
    • Mean change before and after treatment.PhysGA-A is a 100-mm analog scale anchored by “not severe” at 0 and “very severe” at 100.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jason Sluzevich MD, Assistant Professor of Dermatology, College of Medicine – Mayo Clinic
  • Overall Official(s)
    • Jason C Sluzevich, M.D., Principal Investigator, Mayo Clinic

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