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Completed

NCT Number: NCT03816189

Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

Eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. Systemic sclerosis (SSc) is an autoimmune disease with fibrotic skin and lung complications. The profibrosing properties and data from the SSc literature suggest a possible role of the eosinophils in the process of fibrogenesis of SSc.

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Key information

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Claude Huriez, CHU

Lille, France

About this study

it will assess the activation state of blood eosinophils in SSc patients compared to healthy controls (ECP production in vitro, surface activation markers, whole transcriptome array, ..).

it will also study skin eosinophils and their recruitment (extracellular eosinophil granules, eotaxins production in skin, ..)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For SSc patients:
  • Meeting the 2013 ACR-EULAR criteria for diffuse SSc (n = 20) and limited SSc (n = 20)
  • Having signed the informed consent
  • Eosinophils ≥ 0.1 G / L on the last blood test (<3 months)

For healthy subjects:

  • Without chronic pathology requiring long-term treatment
  • Eosinophils between 0.1 and 0.4 G / L on recent blood test (<3 months)

Exclusion criteria

for patients and controls:

  • Patient with an infection, state of emergency or progressive neoplastic pathology
  • Pregnant or lactating women
  • History of atopy (allergic asthma, atopic eczema, allergic rhinitis, allergic conjunctivitis)
  • Allergy to local anesthetics (for scleroderma patients only)
  • Taking into account a minimum weight of 50 kg and in the absence of cardiorespiratory effects of scleroderma, only patients with at least 10 g of hemoglobin will be included

Treatment and study plan

Blood test

Diagnostic Test

Patients in each group will have a blood sample (9x7 mL) for eosinophils isolation, study of activation markers on whole blood and serum biomarkers testing

Skin biopsies

Diagnostic Test

In patients who will accept, skin biopsies will be performed in damaged and apparently normal skin, excluding fingers, hands, feet and face (biopsies are facultative)

Primary outcomes

  1. Comparison of ECP concentrations in supernatants of eosinophils culture

    Time frame: Baseline: one session

    Eosinophils will be sorted, stimulated in vitro for 2 hours and ECP concentration will be assessed in supernatants

Secondary outcomes

  1. Comparison of median fluorescence intensities of several surface markers on blood eosinophils, or comparison of percentages of positive cells among all eosinophils for a given marker (flow cytometry)

    Time frame: Baseline: one session

    MFI/% of CD69, HLA class II, CD9, CD11c, CD44, CCR3, CRTH2, IL-5R on blood eosinophils

  2. Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)

    Time frame: Baseline: one session

    Whole genome, transcriptomic approach (differentially expressed genes will be identified using a fold change cutoff)

  3. In skin biopsies: density of eosinophils, extracellular ECP and MBP deposits (absent in healthy skin), and density of eotaxin-1-producing cells will be assessed in damaged skin and apparently healthy skin of SSc patients

    Time frame: Baseline: one session

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Role of Blood and Tissue Eosinophils in the Fibrogenesis of Systemic Sclerosis

Acronym: EOFIB-SSC

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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