Mepolizumab for Eosinophilic Fasciitis

NCT ID: NCT04305678

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-02-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Eosinophilic Fasciitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mepolizumab for the treatment of eosinophilic faciitis.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Patients with a biopsy proven diagnosis of eosinophilic fasciitis

Group Type EXPERIMENTAL

Mepolizumab

Intervention Type DRUG

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

Interventions

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Mepolizumab

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

Intervention Type DRUG

Other Intervention Names

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Nucala

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jason Sluzevich MD

Assistant Professor of Dermatology, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason C Sluzevich, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Related Links

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Other Identifiers

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19-011851

Identifier Type: -

Identifier Source: org_study_id

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