Systemic Lupus ErythematosusFiNKLUPUSNCT05859191
Study of Neonatal IgG Fc Receptor Expression in Natural Killer T Cells Expressing an Invariant T Receptor : Implication in the Pathophysiology of Systemic Lupus
An observational study of Systemic Lupus Erythematosus and Physiopathology, run by University Hospital, Tours at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Physiopathology
- What is being tested?
- Blood sample
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2023to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients with systemic lupus
Who may be able to join
- 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
Who cannot join
- Main autoimmune disease other than lupus
- Patient under legal protection, guardianship or curators
- Opposition to data processing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valérie GOUILLEUX-GRUART contact
France1 site, 1 recruiting
- Recruiting
University Hospital
Tours, 37044
Yanis RAMDANI, 0234378919 ext. +33, yanis.ramdani@univ-tours.fr
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Systemic Lupus Erythematosus, Physiopathology
- Being tested
- Blood sample
- Keywords
- lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| LUPUS PATIENTS | 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. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
FcRn Expression analysis in Circulating iNKT lymphocytes
by flow cytometry (mean fluorescence intensity)
Measured: through study completion, an average of 3 year
FcRn Expression analysis in circulating monocytes
by flow cytometry (mean fluorescence intensity)
Measured: through study completion, an average of 3 year
FcgammaRII Expression analysis in Circulating iNKT lymphocytes
by flow cytometry (mean fluorescence intensity)
Measured: through study completion, an average of 3 year
FcgammaRII Expression analysis in circulating monocytes
by flow cytometry (mean fluorescence intensity)
Measured: through study completion, an average of 3 year
FcgammaRIII Expression analysis in Circulating iNKT lymphocytes
by flow cytometry (mean fluorescence intensity)
Measured: through study completion, an average of 3 year
FcgammaRIII Expression analysis in in circulating monocytes
by flow cytometry (mean fluorescence intensity)
Measured: through study completion, an average of 3 year
Secondary outcomes (6)
corticotherapy
data collected from patient medical file
Measured: through study completion, an average of 3 year
hydroxychloroquine
data collected from patient medical file
Measured: through study completion, an average of 3 year
immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil
data collected from patient medical file
Measured: through study completion, an average of 3 year
biotherapy: belimumab and rituximab
data collected from patient medical file
Measured: through study completion, an average of 3 year
lupus disease activity
assessed with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). The score ranging from 0 (no activity) to 105
Measured: through study completion, an average of 3 year
albumin and IgG levels
by immunonephelometry
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start21 Jul 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center for Respiratory Diseases, Inserm U1100
- Responsible party
- Sponsor
- Investigators
- Yanis RAMDANI, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859191
- Sponsor's protocol ID
- DR230103-FiNK LUPUS
- Acronym
- FiNKLUPUS
- Status last verified
- Apr 2026
- First submitted
- 3 May 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05859191
- Acronym / sponsor ID
- FiNKLUPUS / DR230103-FiNK LUPUS
- Conditions
- Systemic Lupus Erythematosus, Physiopathology
- Keywords
- lupus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Research Center for Respiratory Diseases, Inserm U1100
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 15 May 2023 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUPUS PATIENTS | – | Biological: Blood sampleThree extra tubes of blood will be taken at each consultation or inpatient visit when routine blood samples are taken as part of lupus monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with systemic lupus
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Main autoimmune disease other than lupus
- Patient under legal protection, guardianship or curators
- Opposition to data processing
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 sampleThree extra tubes of blood will be taken at each consultation or inpatient visit when routine blood samples are taken as part of lupus monitoring. | Biological | LUPUS PATIENTS |
Primary outcome
FcRn Expression analysis in Circulating iNKT lymphocytes
Time frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcRn Expression analysis in circulating monocytes
Time frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRII Expression analysis in Circulating iNKT lymphocytes
Time frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRII Expression analysis in circulating monocytes
Time frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRIII Expression analysis in Circulating iNKT lymphocytes
Time frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
FcgammaRIII Expression analysis in in circulating monocytes
Time frame: through study completion, an average of 3 year
by flow cytometry (mean fluorescence intensity)
6 secondary outcomes
corticotherapy
Time frame: through study completion, an average of 3 year
hydroxychloroquine
Time frame: through study completion, an average of 3 year
immunosuppressants outside of biotherapy: methotrexate, azathioprine, mycophenolate mofetil
Time frame: through study completion, an average of 3 year
biotherapy: belimumab and rituximab
Time frame: through study completion, an average of 3 year
lupus disease activity
Time frame: through study completion, an average of 3 year
albumin and IgG levels
Time frame: through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Valérie GOUILLEUX-GRUART contact
Yanis RAMDANI principal investigator
CHRU de Tours
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 Lupus Erythematosus and Physiopathology, run by University Hospital, Tours 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanis RAMDANI (0234378919 ext. +33, yanis.ramdani@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FcRn Expression analysis in Circulating iNKT lymphocytes (time frame: through study completion, an average of 3 year). The study lists 6 primary outcomes in all. 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 30 Apr 2026.