NCT07260942

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

November 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

April 21, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

November 21, 2025

Last Update Submit

May 13, 2026

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusferroptosisautoimmunity

Outcome Measures

Primary Outcomes (1)

  • Measurement of lipid peroxidation in regulatory T lymphocytes population in lupus subjects.

    At baseline (Day 0)

Secondary Outcomes (5)

  • 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)

Study Arms (2)

Systemic lupus erythematosus (SLE)

EXPERIMENTAL
Biological: blood sample

Rheumatoid arthritis or an inflammatory bowel

ACTIVE COMPARATOR
Biological: blood sample

Interventions

blood sampleBIOLOGICAL

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

Rheumatoid arthritis or an inflammatory bowelSystemic lupus erythematosus (SLE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christophe RICHEZ, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe RICHEZ, Prof

CONTACT

(0)5 56 79 55 56christophe.richez@chu-bordeaux.fr

Thomas BARNETCHE, PhD

CONTACT

(0)5.57.82.04.93thomas.barnetche@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

April 21, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)