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RecruitingNCT07251179AutoB-TetramerUpdated Aug 20, 2026

Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies

An observational study in Systemic Lupus Erythematosus, Systemic Scleroderma and ANCA-associated Vasculitis, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 168 studies in Lupus Erythematosus, Systemic with a site in France — 43 open to participants now, 62 under way, 20 of them phase 3. Lupus Erythematosus, Systemic · France.

Planned enrollment
25th of 48
200 · median 212
Started
2026
with 13 others
Observational
48 of 168
16 open now
Primary completion
2031-12
later than 54 of 61 live
Registered
156th of 168
by date
Lead sponsor
6 of 168
University Hospital, Strasbourg, France

Among the 168 studies in Lupus Erythematosus, Systemic with a site in France, this one is the 25th largest by planned enrollment of the 48 observational ones that give a count, is one of 14 that started in 2026, is one of 48 observational ones, reaches primary completion later than 54 of the 61 other live ones, and was the 156th registered.

Lupus Erythematosus, Systemic

1,208 studies on the registry are indexed under Lupus Erythematosus, Systemic; 404 are open to participants now.

Browse Lupus Erythematosus, Systemic studies →

Open to participants now

43 of the 168 studies in Lupus Erythematosus, Systemic with a site in France are open now. Recruiting first, the newest first:

37 more — sign in →

All 43 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 283 Lupus Erythematosus, Systemic studies recruiting now, 92 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 168 studies in Lupus Erythematosus, Systemic with a site in France, or all of them as a file.
02

Study 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. 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:

i) 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.

03

Conditions studied

  • Systemic Lupus Erythematosus
  • Systemic Scleroderma
  • ANCA-associated Vasculitis
  • Antiphospholipid Syndrome
  • Primary Immunodeficiencies
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hôpitaux Universitaires de Strasbourg

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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 form for non-identifying genetic testing.

Exclusion criteria

Exclusion Criteria:

  • 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 (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)
  • Patient under legal protection
  • Patient under guardianship or conservatorship
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • Biologicalblood draw

    blood draw

06

What researchers measure

Primary outcomes

  1. Study of the percentage of autoreactive LB / tetrameric LB+

    Time frame: inclusion visit

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2031, 71 months after the start.

Of 90 non-industry observational studies under Lupus Erythematosus, Systemic, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 212. This study's planned 71 months is above that.

Counting every sponsor, half of 112 studies reached it within 64 months; a quarter within 34 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 26, 2025
StartActual
Jan 20, 2026
Primary completionEst.
Dec 31, 2031
CompletionEst.
Dec 31, 2031
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07251179
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Jan 20, 2026
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Aug 20, 2026

Study contacts

Anne-Sophie KORGANOW, MD
Contact
anne-sophie.korganow@chru-strasbourg.fr
03 69 55 09 94 ext. 0033

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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