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Recruiting NCT07260942

Ferroptosis Role in the Pathophysiology of Systemic Lupus Erythematosus

No phase Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sample.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Biological blood sample
    30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Primary outcome measures

  • Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects. [Time frame: At baseline (Day 0)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Bordeaux - service de rhumatologie — Bordeaux

Identifiers

NCT: NCT07260942 · CHUBX 2025/003 · 2025-A00880-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗