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NCT Number: NCT05859191

Study of Neonatal IgG Fc Receptor Expression in Natural Killer T Cells Expressing an Invariant T Receptor : Implication in the Pathophysiology of Systemic Lupus

This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Tours, 37044, France

Location status: Recruiting

Location contact

Yanis RAMDANI

CONTACT

[email protected]

0234378919 ext. +33

About this study

The role of FcRn in autoimmune diseases remains to be clarified, but it has been implicated in numerous pathophysiological mechanisms, notably in the management of immune complexes or the recycling of autoantibodies. In humans, this role in the metabolism of autoantibodies has recently led to the development of therapeutic antibodies for autoimmune diseases such as autoimmune thrombocytopenia and myasthenia.

The lupus erythematosus is an auto-immune disease mediated by IgG and immune complexes characterized by a high diversity of autoantibodies and a large dysregulation of the immune system in all it's components, one of them being iNKT cells.

Studies in patients or in lupus mouse models have shown a decrease in iNKT cells correlated with disease activity as well as tissue infiltration in relation to clinical manifestations. Their actual role in this pathology remains to be clarified between regulatory or pro-inflammatory effect.

The possible role of iNKT as a regulatory cell in lupus pathology and the possible involvement of FcRn in their development reinforces the interest of their simultaneous study in humans.

The aim of this study will be to evaluate the impact of the expression of FcRn and other Fc gamma receptors cooperating with FcRn (Fc gamma RII and RIII) in iNKT cells in lupus patients in relation to disease activity and therapy. This study will be conducted in parallel on monocytes, cells involved in the metabolism of immune complexes and likely to be activated by iNKT cells. These results will be compared to healthy controls and integrated into mechanistic studies in a mouse model.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosis of definite systemic lupus which may be associated with secondary antiphospholipid syndrome and/or secondary Gougerot-Sjögren's
  • Lupus patient, newly diagnosed or known, untreated or in relapse
  • Lupus patient considered stable by the treating practitioner
  • Requiring blood sampling for follow-up

Exclusion criteria

  • Main autoimmune disease other than lupus
  • Patient under legal protection, guardianship or curators
  • Opposition to data processing

Treatment and study plan

Blood sample

Biological

Three extra tubes of blood will be taken at each consultation or inpatient visit when routine blood samples are taken as part of lupus monitoring.

Primary outcomes

  1. FcRn Expression analysis in Circulating iNKT lymphocytes

    Time frame: through study completion, an average of 3 year

    by flow cytometry (mean fluorescence intensity)

  2. FcRn Expression analysis in circulating monocytes

    Time frame: through study completion, an average of 3 year

    by flow cytometry (mean fluorescence intensity)

  3. FcgammaRII Expression analysis in Circulating iNKT lymphocytes

    Time frame: through study completion, an average of 3 year

    by flow cytometry (mean fluorescence intensity)

  4. FcgammaRII Expression analysis in circulating monocytes

    Time frame: through study completion, an average of 3 year

    by flow cytometry (mean fluorescence intensity)

  5. FcgammaRIII Expression analysis in Circulating iNKT lymphocytes

    Time frame: through study completion, an average of 3 year

    by flow cytometry (mean fluorescence intensity)

  6. FcgammaRIII Expression analysis in in circulating monocytes

    Time frame: through study completion, an average of 3 year

    by flow cytometry (mean fluorescence intensity)

Secondary outcomes

  1. corticotherapy

    Time frame: through study completion, an average of 3 year

    data collected from patient medical file

  2. hydroxychloroquine

    Time frame: through study completion, an average of 3 year

    data collected from patient medical file

  3. immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil

    Time frame: through study completion, an average of 3 year

    data collected from patient medical file

  4. biotherapy: belimumab and rituximab

    Time frame: through study completion, an average of 3 year

    data collected from patient medical file

  5. lupus disease activity

    Time frame: through study completion, an average of 3 year

    assessed with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). The score ranging from 0 (no activity) to 105

  6. albumin and IgG levels

    Time frame: through study completion, an average of 3 year

    by immunonephelometry

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie GOUILLEUX-GRUART

CONTACT

[email protected]

Yanis RAMDANI

CONTACT

[email protected]

0234378919 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Research Center for Respiratory Diseases, Inserm U1100

Registry information

Official study title

Study of Neonatal Immunoglobulin G (IgG) Fc Receptor (FcRn) Expression in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT): Implication in the Pathophysiology of Systemic Lupus

Acronym: FiNKLUPUS

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
May 15, 2023
Registry last updated
Apr 30, 2026

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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