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Mepolizumab for Eosinophilic Fasciitis

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04305678
Collaborator
GlaxoSmithKline (Industry)
6
Enrollment
1
Arm
35.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Mepolizumab for the treatment of eosinophilic faciitis.Mepolizumab for the treatment of eosinophilic faciitis.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2025
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Patients with a biopsy proven diagnosis of eosinophilic fasciitis

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Rodnan Skin Score (mRSS) [24 weeks]

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

    Secondary Outcome Measures

    1. Localized Scleroderma Skin Severity Index (mLoSSI) score [24 weeks]

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

    2. Localized Scleroderma Damage Index (LoSDI) score. [24 weeks]

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

    3. Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) [24 weeks]

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

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

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

    6. Dermatology Quality of Life Index (DLQI) [24 weeks.]

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

    7. Patient Global Assessment of Disease Severity (PtGA-S) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mayo Clinic
    • GlaxoSmithKline

    Investigators

    • Principal Investigator: Jason C Sluzevich, M.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jason Sluzevich MD, Assistant Professor of Dermatology, College of Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04305678
    Other Study ID Numbers:
    • 19-011851
    First Posted:
    Mar 12, 2020
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Jason Sluzevich MD, Assistant Professor of Dermatology, College of Medicine, Mayo Clinic
    Mepolizumab
    Additional relevant MeSH terms:
    Fasciitis
    Eosinophilia

    Study Results

    No Results Posted as of Jan 20, 2022