Ferroptosis Role in the Pathophysiology of Systemic Lupus Erythematosus

NCT ID: NCT07260942

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Systemic lupus erythematosus (SLE)

Group Type EXPERIMENTAL

blood sample

Intervention Type BIOLOGICAL

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

Rheumatoid arthritis or an inflammatory bowel

Group Type ACTIVE_COMPARATOR

blood sample

Intervention Type BIOLOGICAL

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

Interventions

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blood sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe RICHEZ, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux - service de rhumatologie

Bordeaux, , France

Site Status

Countries

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France

Central Contacts

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Christophe RICHEZ, Prof

Role: CONTACT

(0)5 56 79 55 56 ext. +33

Thomas BARNETCHE, PhD

Role: CONTACT

(0)5.57.82.04.93 ext. +33

Facility Contacts

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Christophe RICHEZ, Prof

Role: primary

(0)5.56.79.55.56 ext. +33

Thomas BARNETCHE, PhD

Role: backup

(0)5.57.82.04.93 ext. +33

Other Identifiers

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CHUBX 2025/003

Identifier Type: -

Identifier Source: org_study_id

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