Ferroptosis Role in the Pathophysiology of Systemic Lupus Erythematosus (FERROLUP)

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: blood sample

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas BARNETCHE, PhD; Phone Number: +33 (0)5.57.82.04.93; Email: thomas.barnetche@chu-bordeaux.fr
• Study Contact Backup: Name: Christophe RICHEZ, Prof; Phone Number: +33 (0)5 56 79 55 56; Email: christophe.richez@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux - service de rhumatologie
    • Contact: Thomas BARNETCHE, PhD; Phone Number: +33 (0)5.57.82.04.93; Email: thomas.barnetche@chu-bordeaux.fr
    • Principal Investigator: Christophe RICHEZ, Prof
    • Sub-Investigator: Estibaliz LAZARO, Prof
    • Sub-Investigator: Lionel COUZI, Prof
    • Sub-Investigator: Julien SENESCHAL, Prof
    • Sub-Investigator: Pauline RIVIERE, MD
    • Contact: Christophe RICHEZ, Prof; Phone Number: +33 (0)5.56.79.55.56; Email: christophe.richez@chu-bordeaux.fr
    • Sub-Investigator: Noemie GENSOUS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systemic lupus erythematosus (SLE)	Biological: blood sample; 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Active Comparator: Rheumatoid arthritis or an inflammatory bowel	Biological: blood sample; 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects.	At baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects and controls.	At baseline (Day 0)
Measurement of lipid peroxidation in other immune cells (T and B lymphocyte populations) in lupus subjects and controls	At baseline (Day 0)
GPX4 expression in lupus subjects and controls.	At baseline (Day 0)
Correlation between ferroptosis markers and the level of activity in B lymphocyte populations	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	At baseline (Day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Christophe RICHEZ, Prof, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Systemic lupus erythematosus; autoimmunity; ferroptosis
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: CHUBX 2025/003; 2025-A00880-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No