Systemic SclerosisEOFIB-SSCNCT03816189
Role of Eosinophil in Fibrogenesis of Systemic Sclerosis
An observational study of Systemic Sclerosis and Systemic Scleroderma, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Systemic Scleroderma
- What is being tested?
- Blood test and Skin biopsies
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2018to 5 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The active line of the Internal Medicine department (> 400 sclerodermic patients) guarantees the recruitment of 20 diffuse forms and 20 limited forms
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Blood and Tissue Eosinophils in the 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.
Read the detailed description
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, ..)
- Conditions
- Systemic Sclerosis, Systemic Scleroderma
- Being tested
- Blood test, Skin biopsies
- Keywords
- Eosinophil, Fibrosis, Systemic Scleroderma
- Medical subject headings
- Scleroderma, Systemic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic 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 biopsiesDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Diffuse SSc | Recruitment of 20 patients with diffuse SSc Receives: Diagnostic Test: Blood test; Diagnostic Test: Skin biopsies | |
| Limited SSc | Recruitment of 20 patients with limited SSc Receives: Diagnostic Test: Blood test; Diagnostic Test: Skin biopsies | |
| Healthy subjects | Recruitment of 20 healthy subjects (control) Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ECP concentrations in supernatants of eosinophils culture
Eosinophils will be sorted, stimulated in vitro for 2 hours and ECP concentration will be assessed in supernatants
Measured: Baseline: one session
Secondary outcomes (3)
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)
MFI/% of CD69, HLA class II, CD9, CD11c, CD44, CCR3, CRTH2, IL-5R on blood eosinophils
Measured: Baseline: one session
Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)
Whole genome, transcriptomic approach (differentially expressed genes will be identified using a fold change cutoff)
Measured: Baseline: one session
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
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start3 Oct 2018
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Guillaume Lefevre, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816189
- Sponsor's protocol ID
- 2017_10
- Other IDs
- 2017-A02587-46
- Acronym
- EOFIB-SSC
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Blood and Tissue Eosinophils in the Fibrogenesis of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03816189
- Acronym / sponsor ID
- EOFIB-SSC / 2017_10
- Conditions
- Systemic Sclerosis, Systemic Scleroderma
- Keywords
- Eosinophil, Fibrosis, Systemic Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, ..)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diffuse SSc | – | Diagnostic Test: Blood test, Diagnostic Test: Skin biopsiesRecruitment of 20 patients with diffuse SSc |
| Limited SSc | – | Diagnostic Test: Blood test, Diagnostic Test: Skin biopsiesRecruitment of 20 patients with limited SSc |
| Healthy subjects | – | Diagnostic Test: Blood testRecruitment of 20 healthy subjects (control) |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The active line of the Internal Medicine department (> 400 sclerodermic patients) guarantees the recruitment of 20 diffuse forms and 20 limited forms
Key inclusion criteria (7 listed)
- 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)
- Without chronic pathology requiring long-term treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testPatients in each group will have a blood sample (9x7 mL) for eosinophils isolation, study of activation markers on whole blood and serum biomarkers testing | Diagnostic test | Diffuse SSc, Healthy subjects, Limited SSc |
| Skin biopsiesIn patients who will accept, skin biopsies will be performed in damaged and apparently normal skin, excluding fingers, hands, feet and face (biopsies are facultative) | Diagnostic test | Diffuse SSc, Limited SSc |
Primary outcome
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
3 secondary outcomes
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
Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)
Time frame: Baseline: one session
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Lefevre, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Systemic Scleroderma, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ECP concentrations in supernatants of eosinophils culture (time frame: Baseline: one session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.