Mepolizumab for Eosinophilic Fasciitis | NCT04305678

Studies
Mepolizumab for Eosinophilic Fasciitis

NCT04305678

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Nov 20, 2024Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Eosinophilic Fasciitis

Interventions

Mepolizumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding lost from Sponsor.

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Feb 15, 2023Actual

Completion Date

Feb 15, 2023Actual

First Submitted Date

Mar 10, 2020

First Submission Date that Met QC Criteria

Mar 10, 2020

First Posted Date

Mar 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	Patients with a biopsy proven diagnosis of eosinophilic fasciitis	Drug: Mepolizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mepolizumab	Drug	Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Localized Scleroderma Skin Severity Index (mLoSSI) score	Mean change before and after treatment. mLoSSI score quantifies disease activity.	24 weeks
Localized Scleroderma Damage Index (LoSDI) score.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jason C Sluzevich, M.D.	Mayo Clinic	Principal Investigator

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C562487	Eosinophilic Fasciitis

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C434107	mepolizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided