BREGS - IL-2 Signaling and Polarization of Regulatory LBs: Involvement in Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing and progressiveNCT04697407

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Blood sampling
  • CSF sampling

What it measured

Main measures

  • Frequency of Bregs in blood of MS patients

    1 month

Other measures (3)

  • Frequency of Bregs in the CSF of MS patients

    1 month

    Blood or spinal fluid markers
  • Comparison of IL-2, soluble IL2RA, IL-10, IL-21 and IL-5 protein concentrations

    1 month

    Blood or spinal fluid markersImmune response
  • Comparison of the concentrations in Igs

    1 month

    Blood or spinal fluid markers

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

About the patients,Inclusion Criteria : * Patients at the onset of illness : * With a strong suspicion of MS requiring an LP to confirm the diagnosis (suggestive neurological symptoms AND more than two typical lesions on MRI) ; OR * MS patients (untreated RR, SP or PP) : * With MS that meets the MacDonald 2017 criteria; * With relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP) MS; OR * Non-MS patients : * Presenting a non MS neurological inflammatory disease (meningitis, neurolupus, neurosarcoidosis, autoimmune encephalitis, acute polyradiculoneuritis); * Benefiting from an LP for diagnostic or monitoring purposes; AND * At least 18 years old; * Without immunomodulating or immunosuppressive background treatment for at least 3 months; * Without systemic corticosteroid treatment for at least 3 months; * Having signed a free, informed and written consent. * Affiliated with a social security system About healthy volunteers, inclusion criteria : * At least 18 years old; * Having signed a free, informed and written consent. * Affiliated with a social security system

Exclusion criteria

For all groups * Pregnancy ; * Breastfeeding ; * Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty. Healthy volunteers : * Absence of autoimmune pathologies * Without immunomodulating or immunosuppressive background treatment for at least 3 months; * Without systemic corticosteroid treatment for at least 3 months.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Multiple sclerosis (MS) has long been considered a disease mediated primarily by CD4+ T cells. However, recent clinical trials demonstrating significant efficacy of B-lymphocyte depletive therapies have highlighted the major role of this cell population in the development of MS. Among B-Ls, regulatory ("anti-inflammatory") B-Ls (Bregs) have protective functions in autoimmune diseases including MS, however the mechanisms that regulate the development and function of Bregs are poorly characterized. In our research laboratory (INSERM UMR1236), one of the lines of research focuses on the role of interleukin-2 (IL-2) signaling in the fate of the B lymphocyte. Numerous studies conducted in both human and mouse models of MS demonstrate the major role of this IL-2/IL2R signaling pathway in the pathogenesis of autoimmune diseases. The hypothesis is that IL-2/IL2R pathway could contribute, by a mechanism intrinsic to B lymphocytes, to the development of autoimmune diseases such as MS. While a defect in IL-2 signaling plays a critical role in the pathogenesis of MS, the impact of this defective signaling on regulatory B lymphocyte populations, which has been shown to play a protective role in the development of the disease, has never been studied. This study could help establish a new mechanism predisposing patients to develop the disease.

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History

    1. Started

      Mar 2021

    2. Main results due

      May 2023

    3. Finished

      May 2023

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