Systemic Lupus ErythematosusAutoB-TetramerNCT07251179
Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies
An observational study of Systemic Lupus Erythematosus and Systemic Scleroderma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis
- What is being tested?
- blood draw
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2026to 31 Dec 2031
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hôpitaux Universitaires de Strasbourg
Who may be able to join
- Patients aged between 18 and 70
- Patients for whom at least one of the following conditions has been confirmed:
- Systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria.
- Systemic scleroderma meeting the 2013 ACR/EULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR/ACR classification criteria.
- Antiphospholipid syndrome according to the 2023 ACR/EULAR criteria.
- Primary immunodeficiencies according to IUIS criteria.
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- Patients capable of understanding the objectives of the research.
- Patients affiliated with a social security health insurance scheme (beneficiary or dependant).
- Patients who have signed and dated the informed consent form for non-identifying genetic testing.
Who cannot join
- Patient refusing to participate in the study
- Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)
- Patient under legal protection
- Patient under guardianship or conservatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Anne-Sophie KORGANOW, MD, +33369551123 ext. 0033, anne-sophie.korganow@chru-strasbourg.fr
anne-sophie.korganow@chru-strasbourg.fr
About this study
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results:
- the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive/pathogenic B cells using high-throughput flow cytometry in several clinical situations.
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis, Antiphospholipid Syndrome, Primary Immunodeficiencies
- Being tested
- blood draw
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawBiological
blood draw
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus | Not described Receives: Biological: blood draw | |
| Systemic scleroderma | Not described Receives: Biological: blood draw | |
| ANCA-associated vasculitis | Not described Receives: Biological: blood draw | |
| Antiphospholipid syndrome | Not described Receives: Biological: blood draw | |
| Primary immunodeficiencies | Not described Receives: Biological: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the percentage of autoreactive LB / tetrameric LB+
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start20 Jan 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (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, Strasbourg, FranceThe 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251179
- Sponsor's protocol ID
- 9942
- Acronym
- AutoB-Tetramer
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies
- ClinicalTrials.gov ID
- NCT07251179
- Acronym / sponsor ID
- AutoB-Tetramer / 9942
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis, Antiphospholipid Syndrome, Primary Immunodeficiencies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 26 Nov 2025 (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.
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results:
- the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive/pathogenic B cells using high-throughput flow cytometry in several clinical situations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus | – | Biological: blood draw |
| Systemic scleroderma | – | Biological: blood draw |
| ANCA-associated vasculitis | – | Biological: blood draw |
| Antiphospholipid syndrome | – | Biological: blood draw |
| Primary immunodeficiencies | – | Biological: blood draw |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hôpitaux Universitaires de Strasbourg
Key inclusion criteria (9 listed)
- Patients aged between 18 and 70
- Patients for whom at least one of the following conditions has been confirmed:
- Systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria.
- Systemic scleroderma meeting the 2013 ACR/EULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR/ACR classification criteria.
- Antiphospholipid syndrome according to the 2023 ACR/EULAR criteria.
Key exclusion criteria (4 listed)
- Patient refusing to participate in the study
- Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)
- Patient under legal protection
- Patient under guardianship or conservatorship
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 drawblood draw | Biological | ANCA-associated vasculitis, Antiphospholipid syndrome, Primary immunodeficiencies, Systemic lupus erythematosus, Systemic scleroderma |
Primary outcome
Study of the percentage of autoreactive LB / tetrameric LB+
Time frame: inclusion visit
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 20 Aug 2026.
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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.
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 Systemic Scleroderma, run by University Hospital, Strasbourg, France 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 9 inclusion and 4 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 20 Aug 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 Anne-Sophie KORGANOW, MD (03 69 55 09 94 ext. 0033, anne-sophie.korganow@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the percentage of autoreactive LB / tetrameric LB+ (time frame: inclusion visit). 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 20 Aug 2026.