Mepolizumab for Eosinophilic Fasciitis

February 13, 2023 updated by: Jason Sluzevich MD, Mayo Clinic

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localized Scleroderma Skin Severity Index (mLoSSI) score
Time Frame: 24 weeks
Mean change before and after treatment. mLoSSI score quantifies disease activity.
24 weeks
Localized Scleroderma Damage Index (LoSDI) score.
Time Frame: 24 weeks
Mean change before and after treatment. LoSDI score quantifies disease damage.
24 weeks
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).
24 weeks
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.
24 weeks
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.
24 weeks.
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
24 weeks.
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.
24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (ACTUAL)

March 12, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-011851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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