Systemic Lupus ErythematosusFERROLUPNCT07260942
Ferroptosis Role in the Pathophysiology of Systemic Lupus Erythematosus
A study testing blood sample in people with Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study aims at defining the role of ferroptosis s in the physiopathology of systemic lupus erythematosus (SLE). Ferroptosis (phenomenon of cellular death regulated by iron) is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2026to Apr 2029
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years;
- diagnosis of systemic lupus erythematosus;
- being affiliated to health insurance, willing to participate and to sign informed consent;
- control group : patients with a diagnosis of rheumatoid arthritis or an inflammatory bowel disease.
Who cannot join
- pregnant or breastfeeding women;
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
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
CHU de Bordeaux - service de rhumatologie
Bordeaux
Christophe RICHEZ, Prof, (0)5.56.79.55.56 ext. +33, christophe.richez@chu-bordeaux.fr
Thomas BARNETCHE, PhD, (0)5.57.82.04.93 ext. +33, thomas.barnetche@chu-bordeaux.fr
About this study
The study aims at defining the role of ferroptosis s in the physiopathology of systemic lupus erythematosus (SLE). Ferroptosis (phenomenon of cellular death regulated by iron) is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.
Read the detailed description
Systemic lupus erythematosus (SLE) is a complex autoimmune disease affecting various organs. Regulatory T cells (Treg) and platelets play a crucial role in the pathogenesis of SLE by regulating immunity and promoting inflammation. Ferroptosis, an iron-regulated cell death process, is emerging as a key player in many diseases, including SLE.
The project, FERROLUP, aims to understand the role of ferroptosis in SLE and to explore the therapeutic potential of selenium compounds to modulate this process. Recent work has identified down-regulation of glutathione peroxidase 4 (GPx4) by immune complexes and interferon-alpha in neutrophils, leading to ferroptosis and worsening of SLE. In addition, data suggest the involvement of ferroptosis in lupus nephritis.
The Bordeaux team has developed selenium compounds, GPx4 mimics, capable of inhibiting ferroptosis in lupus neutrophils. These compounds have shown promising efficacy in mouse models and preliminary human studies in another inflammatory disease. The FERROLUP project aims to characterize the level of lipid peroxidation and GPx4 expression in SLE patients, and to test the impact of selenium compounds on the inhibition of ferroptosis induced by P-selectin, a molecule involved in Treg dysfunction.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- blood sample
- Keywords
- Systemic lupus erythematosus, ferroptosis, autoimmunity
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus (SLE) | Experimental | Not described Receives: Biological: blood sample |
| Rheumatoid arthritis or an inflammatory bowel | Active comparator | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects.
Measured: At baseline (Day 0)
Secondary outcomes (5)
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects and controls.
Measured: At baseline (Day 0)
Measurement of lipid peroxidation in other immune cells (T and B lymphocyte populations) in lupus subjects and controls
Measured: At baseline (Day 0)
GPX4 expression in lupus subjects and controls.
Measured: At baseline (Day 0)
Correlation between ferroptosis markers and the level of activity in B lymphocyte populations
Measured: At baseline (Day 0)
In-vitro effect of BXT on different T lymphocytes population in the presence of P-selectin in sera of lupus subjects and controls
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start21 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (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, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe RICHEZ, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260942
- Sponsor's protocol ID
- CHUBX 2025/003
- Other IDs
- 2025-A00880-49
- Acronym
- FERROLUP
- Status last verified
- May 2026
- First submitted
- 21 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferroptosis Role in the Pathophysiology of Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07260942
- Acronym / sponsor ID
- FERROLUP / CHUBX 2025/003
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, ferroptosis, autoimmunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 3 Dec 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.
The study aims at defining the role of ferroptosis s in the physiopathology of systemic lupus erythematosus (SLE). Ferroptosis (phenomenon of cellular death regulated by iron) is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.
Detailed description
Systemic lupus erythematosus (SLE) is a complex autoimmune disease affecting various organs. Regulatory T cells (Treg) and platelets play a crucial role in the pathogenesis of SLE by regulating immunity and promoting inflammation. Ferroptosis, an iron-regulated cell death process, is emerging as a key player in many diseases, including SLE.
The project, FERROLUP, aims to understand the role of ferroptosis in SLE and to explore the therapeutic potential of selenium compounds to modulate this process. Recent work has identified down-regulation of glutathione peroxidase 4 (GPx4) by immune complexes and interferon-alpha in neutrophils, leading to ferroptosis and worsening of SLE. In addition, data suggest the involvement of ferroptosis in lupus nephritis.
The Bordeaux team has developed selenium compounds, GPx4 mimics, capable of inhibiting ferroptosis in lupus neutrophils. These compounds have shown promising efficacy in mouse models and preliminary human studies in another inflammatory disease. The FERROLUP project aims to characterize the level of lipid peroxidation and GPx4 expression in SLE patients, and to test the impact of selenium compounds on the inhibition of ferroptosis induced by P-selectin, a molecule involved in Treg dysfunction.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus (SLE) | Experimental | Biological: blood sample |
| Rheumatoid arthritis or an inflammatory bowel | Active comparator | Biological: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years;
- diagnosis of systemic lupus erythematosus;
- being affiliated to health insurance, willing to participate and to sign informed consent;
- control group : patients with a diagnosis of rheumatoid arthritis or an inflammatory bowel disease.
Key exclusion criteria (2 listed)
- pregnant or breastfeeding women;
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
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 sample30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Biological | Rheumatoid arthritis or an inflammatory bowel, Systemic lupus erythematosus (SLE) |
Primary outcome
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects.
Time frame: At baseline (Day 0)
5 secondary outcomes
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects and controls.
Time frame: At baseline (Day 0)
Measurement of lipid peroxidation in other immune cells (T and B lymphocyte populations) in lupus subjects and controls
Time frame: At baseline (Day 0)
GPX4 expression in lupus subjects and controls.
Time frame: At baseline (Day 0)
Correlation between ferroptosis markers and the level of activity in B lymphocyte populations
Time frame: At baseline (Day 0)
In-vitro effect of BXT on different T lymphocytes population in the presence of P-selectin in sera of lupus subjects and controls
Time frame: At baseline (Day 0)
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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
Christophe RICHEZ, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Systemic Lupus Erythematosus, run by University Hospital, Bordeaux 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 4 inclusion and 2 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 18 May 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 Christophe RICHEZ, Prof ((0)5 56 79 55 56 ext. +33, christophe.richez@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects. (time frame: At baseline (Day 0)). 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 18 May 2026.