Status:
WITHDRAWN
Mepolizumab for Eosinophilic Fasciitis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Eosinophilic Fasciitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04305678
Start Date
February 1 2023
End Date
February 15 2023
Last Update
November 20 2024
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