Mepolizumab for Eosinophilic Fasciitis

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04305678

Enrollment

Registered

2020-03-12

Start date

2023-02-28

Completion date

2023-02-15

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Fasciitis

Keywords

Mepolizumab

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 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.

Interventions

DRUGMepolizumab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Mepolizumab for the treatment of eosinophilic faciitis.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Modified Rodnan Skin Score (mRSS)	24 weeks	Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026