Systemic Sclerosis and Innate T Cells

May 21, 2026 updated by: Poitiers University Hospital

Role of Innate T Cells in Physiopathology of Systemic Sclerosis

Innate T cells (ITC) are decreased in systemic sclerosis (SS) and an early lymphocyte innateness has been reported. In the other part, ITC are implicated on inflammatory process, including the IL-33/ST2 axis, which is also involved in ScS endotheliopathy.

Data are however scarce and physiopathological mechanisms have not been assessed to date.

The investigators hypothesize a global lymphocyte innateness in SSc, linked to a chronic ITC stimulation by innate signals leading to ITC exhaustion, and their potential role in endotheliopathy and fibroblast activation in SSc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France
        • CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • SSc according to the 2013 ACR/EULAR 2013 criteria (or the 2001 Leroy's criteria for early SSc)

  • Patients with others connective tissue disease:

    • Systemic erythematosus lupus (SLE) according to the 2019 ACR/EULAR criteria
    • Primary Sjögren syndrome (pSS) according to the 2016 ACR/EULAR criteria
    • Rheumatoid arthritis according to the 2010 ACR/EULAR criteria
    • Idiopathic inflammatory myopathy (IIM) according to the 2017 ACR/EULAR criteria
  • Healthy subjects from general population without known autoimmune disease or connective tissue disease
  • ≥18 years-old

Exclusion Criteria:

  • Overlap syndrome (including secondary Sjögren syndrome)
  • Weight <55 kgs
  • Known primary cell immunodeficiency
  • Past of autologous or allogenic hematopoietic stem cell transplantation
  • Solid neoplasia or malignant hemopathy in remission for less than 12 months an
  • Chemotherapy and/or immune checkpoint inhibitors in the last 12 months
  • Systemic retinoids
  • Active infection and/or antibiotics in the last 2 weeks
  • Known active chronic infection among HIV, HTLV, viral hepatitis, syphilis
  • Vaccination in the last 4 weeks
  • Subject refusing genetic analysis for the present study
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blood test
Unique blood test for all the participants included in the study to constitute a local biobank to assess in a grouped manner the prespecified outcomes
Other: Blood test
Unique blood draw of 45mL for all the participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basal numeration of circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Time Frame: Through study completion, an average of 1 year
Percentage AND absolute count of iNKT, MAIT, γδ-T and innate CD8(+) T- cells in flow cytometry among total T cells in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)
Through study completion, an average of 1 year
Basal expression level of Ki67 among circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Time Frame: Through study completion, an average of 1 year
Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing Ki67 in flow cytometry in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)
Through study completion, an average of 1 year
Basal expression level of PLZF AND Eomes AND T-bet AND Helios of circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Time Frame: Through study completion, an average of 1 year
Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing PLZF, Eomes, T-bet and Helios in flow cytometry in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)
Through study completion, an average of 1 year
Basal expression of perforin AND granzyme A among circulating ITC (iNKT, MAIT, γδ-T and innate CD8(+) T-cells)
Time Frame: Through study completion, an average of 1 year
Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing perforin and granzyme A in flow cytometry in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)
Through study completion, an average of 1 year
IFN-ɣ, IL-4 and IL-17 production of iNKT, MAIT, γδ-T and innate CD8(+) T-cells in response to IL-1, IL-8, IL-12, IL-18, IL-33 and fractalkine
Time Frame: Through study completion, an average of 1 year
Percentage of iNKT, MAIT, γδ-T and innate CD8(+) T-cells expressing IFN-ɣ AND IL-4 AND IL-17 in flow cytometry upon stimulation by various combinations of IL-1, IL-8, IL-12, IL-18, IL-33 and fractalkine in SSc patients (n=60), patients with other connective tissue disease (systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's syndrome, idiopathic inflammatory myopathies) (n=60), and in healthy subjects (n=60)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

December 12, 2025

Study Completion (Actual)

December 17, 2025

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sclero-LTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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