NCT04305678

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
2.9 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

14 days

First QC Date

March 10, 2020

Last Update Submit

November 18, 2024

Conditions

Eosinophilic Fasciitis

Keywords

Mepolizumab

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (7)

  • Localized Scleroderma Skin Severity Index (mLoSSI) score

    24 weeks

  • Localized Scleroderma Damage Index (LoSDI) score.

    24 weeks

  • Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)

    24 weeks

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

    24 weeks

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

    24 weeks.

  • +2 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL

Patients with a biopsy proven diagnosis of eosinophilic fasciitis

Drug: Mepolizumab

Interventions

MepolizumabDRUG

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

Also known as: Nucala
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Eosinophilic Fasciitis

Interventions

mepolizumab

Study Officials

  • Jason C Sluzevich, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mepolizumab for the treatment of eosinophilic faciitis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology, College of Medicine

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

February 1, 2023

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share