Scleroderma, SystemicSCLERO-LBNCT03559465
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
A study testing skin biopsy and Blood punction in people with Scleroderma, Systemic, run by University Hospital, Lille at 1 site in France.
Trial summary
B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- skin biopsy and Blood punction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2018to 14 Feb 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients
- systemic sclerosis according to ACR-EULAR 2013
- written consent
- available insurance
- Healthy "blood" and healthy "biopsy" controls
- written consent
- available insurance
Who cannot join
- patients
- overlap with other connective tissue diseases
- immunosuppressants in the past 12 months
- corticosteroids ≥10mg/d
- pregnancy or breast feeding
- Healthy "blood" and healthy "biopsy" controls
Show all 13Show fewer
- systemic sclerosis according to ACR-EULAR 2013
- another connective tissue diseases
- immunosuppressants in the past 12 months
- corticosteroids ≥10mg/d
- pregnancy or breast feeding
- With dysimmune inflammatory diseases (except thyroiditis)
- Presenting an infection in progress or within the previous 15 days
Trial locations and contacts
1 site in 1 country.
About this study
B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.
Read the detailed description
B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.
- Conditions
- Scleroderma, Systemic
- Being tested
- skin biopsy, Blood punction
- Keywords
- systemic sclerosis, B lymphocyte
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
A skin biopsy will be performed in 10 patients in the form of 2 punches of 5 mm in the injured area in aseptic condition with a Rodnan score.
In this study, 10 skin biopsies are needed, and will be performed on the first 10 patients accepting this biopsy.
Blood punctionOther
1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte
| Study group | Role | What they receive |
|---|---|---|
| patient with Scs | Experimental | patients with SSc, (10 diffuse forms and 20 limited forms) Receives: Procedure: skin biopsy; Other: Blood punction |
| healthy subject | Sham comparator | Not described Receives: Other: Blood punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast transcriptomic : myofibroblast signature
expression of alpha Smooth Muscle Actin
Measured: 36 months
Secondary outcomes (3)
Fibroblast transcriptomic
expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
Measured: 36 months
Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups
Measured: 36 months
Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start29 Oct 2018
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559465
- Sponsor's protocol ID
- 2016_63
- Other IDs
- 2017-A02720-53
- Acronym
- SCLERO-LB
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 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
- Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
- ClinicalTrials.gov ID
- NCT03559465
- Acronym / sponsor ID
- SCLERO-LB / 2016_63
- Conditions
- Scleroderma, Systemic
- Keywords
- systemic sclerosis, B lymphocyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 18 Jun 2018 (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.
B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.
Detailed description
B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with Scs | Experimental | Procedure: skin biopsy, Other: Blood punctionpatients with SSc, (10 diffuse forms and 20 limited forms) |
| healthy subject | Sham comparator | Other: Blood punction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients
- systemic sclerosis according to ACR-EULAR 2013
- written consent
- available insurance
- Healthy "blood" and healthy "biopsy" controls
Key exclusion criteria (13 listed)
- patients
- overlap with other connective tissue diseases
- immunosuppressants in the past 12 months
- corticosteroids ≥10mg/d
- pregnancy or breast feeding
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 |
|---|---|---|
| skin biopsyA skin biopsy will be performed in 10 patients in the form of 2 punches of 5 mm in the injured area in aseptic condition with a Rodnan score. In this study, 10 skin biopsies are needed, and will be performed on the first 10 patients accepting this biopsy. | Procedure or surgery | patient with Scs |
| Blood punction1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte | Other | healthy subject, patient with Scs |
Primary outcome
Fibroblast transcriptomic : myofibroblast signature
Time frame: 36 months
expression of alpha Smooth Muscle Actin
3 secondary outcomes
Fibroblast transcriptomic
Time frame: 36 months
Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups
Time frame: 36 months
Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups
Time frame: 36 months
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.
David Launay, MD,PhD 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?
A study testing skin biopsy and Blood punction in people with Scleroderma, Systemic, 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 13 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. Some participants in this study may receive a placebo. 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?
Fibroblast transcriptomic : myofibroblast signature (time frame: 36 months). 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.