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NCT Number: NCT07788573

The Role of the FCRL5 Protein in the Pathophysiology of Multiple Sclerosis and Response to Treatment

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS) and the leading non-traumatic cause of neurological disability in young adults. Historically considered a T-cell-mediated disease, the paradigm for MS has shifted thanks to the efficacy of therapies targeting B cells. The investigators recently identified FCRL5 as a B-cell-specific biomarker that is significantly elevated in the cerebrospinal fluid (CSF) of patients with relapsing-remitting MS and is independently associated with an increased risk of developing new MRI lesions within two years of diagnosis (ref. Deltombe et al., PMID: 41004694). This project aims to further explore FCRL5 as a prognostic biomarker, study the role of FCRL5-expressing B cells in MS pathogenesis and the effects of disease-modifying therapies on these subsets.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Université Catholique de Louvain

Brussels, 1200, Belgium

Location contact

Vincent Van Pesch, MD, PhD

CONTACT

[email protected]

003227641082

Vincent Van Pesch, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For MS patients:
  • Male or female
  • Between 18 and 80 years of age
  • Diagnosed with MS according to the most recent McDonald criteria (2025)
  • Patients who are about to start a new MS treatment or switch treatments

For healthy volunteers:

  • Men or women
  • Ages 18 to 80
  • Healthy volunteers with no neurological conditions or autoimmune diseases

For participants with Sjögren's syndrome:

  • Men or women
  • Ages 18 to 80

Exclusion criteria

  • For MS patients:
  • No recent relapse (during the 3 months prior to study enrollment)
  • Patients treated with corticosteroids (during the 3 months prior to study enrollment)
  • Patients receiving another immunosuppressive therapy unrelated to MS
  • Inability to sign the informed consent form

For healthy volunteers:

Subjects not receiving immunosuppressive therapy

For subjects with Sjögren's syndrome:

Subjects not receiving immunosuppressive therapy

Treatment and study plan

A blood test every 6 months for MS patients.

Other

A blood test every 6 months for MS patients : Day1, Month 6, Month 12 and Month 24

A single blood draw for the healthy volunteer

Other

A single blood draw for the healthy volunteer

A single blood draw for the group of volunteers with Sjögren's syndrome

Other

A single blood draw for the group of volunteers with Sjögren's syndrome

Primary outcomes

  1. Characterization of the phenotype of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS

    Time frame: Throughout the entire study, approximately during 40 months

  2. Characterization of the activity of peripheral CD19⁺CD11c⁺FCRL5⁺ B lymphocytes in patients with MS

    Time frame: Throughout the entire study, approximately during 40 months

Secondary outcomes

  1. Immunological role of CD19⁺CD11c⁺FCRL5⁺ B cells in the pathogenesis of MS.

    Time frame: Throughout the entire study, approximately during 40 months

  2. Correlations in the participants' clinical, biological, radiological profiles and the immunological characteristics

    Time frame: Throughout the entire study, approximately during 40 months

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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