Mepolizumab for Eosinophilic Fasciitis

Eosinophilic Fasciitis Clinical Trial

Official title:

Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04305678
• Other study ID #: 19-011851
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilia
• Eosinophilic Fasciitis
• Fasciitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Localized Scleroderma Skin Severity Index (mLoSSI) score	Mean change before and after treatment. mLoSSI score quantifies disease activity.	24 weeks
Secondary	Localized Scleroderma Damage Index (LoSDI) score.	Mean change before and after treatment. LoSDI score quantifies disease damage.	24 weeks
Secondary	Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)	Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).	24 weeks
Secondary	Physician's Global Assessment of Disease Activity (PhysGA-A)	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
Secondary	Physician's Global Assessment of Disease Damage (PhysGA-D)	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.
Secondary	Dermatology Quality of Life Index (DLQI)	Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life	24 weeks.
Secondary	Patient Global Assessment of Disease Severity (PtGA-S)	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.

External Links

•   Mayo Clinic Clinical Trials