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Mepolizumab for Eosinophilic Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305678
Recruitment Status : Not yet recruiting
First Posted : March 12, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Jason Sluzevich MD, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Eosinophilic Fasciitis Drug: Mepolizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Mepolizumab for the treatment of eosinophilic faciitis.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Mepolizumab

Arm Intervention/treatment
Experimental: Single Arm
Patients with a biopsy proven diagnosis of eosinophilic fasciitis
Drug: Mepolizumab
Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks
Other Name: Nucala




Primary Outcome Measures :
  1. Modified Rodnan Skin Score (mRSS) [ Time Frame: 24 weeks ]
    Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.


Secondary Outcome Measures :
  1. Localized Scleroderma Skin Severity Index (mLoSSI) score [ Time Frame: 24 weeks ]
    Mean change before and after treatment. mLoSSI score quantifies disease activity.

  2. Localized Scleroderma Damage Index (LoSDI) score. [ Time Frame: 24 weeks ]
    Mean change before and after treatment. LoSDI score quantifies disease damage.

  3. Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) [ Time Frame: 24 weeks ]
    Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).

  4. Physician's Global Assessment of Disease Activity (PhysGA-A) [ Time Frame: 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.

  5. Physician's Global Assessment of Disease Damage (PhysGA-D) [ Time Frame: 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.

  6. Dermatology Quality of Life Index (DLQI) [ Time Frame: 24 weeks. ]
    Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life

  7. Patient Global Assessment of Disease Severity (PtGA-S) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305678


Contacts
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Contact: Jason C Sluzevich, M.D. 904-953-2000 sluzevich.jason@mayo.edu

Sponsors and Collaborators
Mayo Clinic
GlaxoSmithKline
Investigators
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Principal Investigator: Jason C Sluzevich, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Jason Sluzevich MD, Assistant Professor of Dermatology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04305678    
Other Study ID Numbers: 19-011851
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jason Sluzevich MD, Mayo Clinic:
Mepolizumab
Additional relevant MeSH terms:
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Fasciitis
Eosinophilia
Musculoskeletal Diseases
Leukocyte Disorders
Hematologic Diseases