ClinicalTrials.gg
Status unknownNCT04117529CaReLyBPUpdated Jan 8, 2021

Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus

An interventional study of Blood sample in Pemphigus Vulgaris and Pemphigus Foliaceus, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Pemphigus is a rare autoimmune disease involving skin and mucous membranes characterized by the production of pathogenic autoantibodies directed against desmosomal transmembrane glycoproteins belonging to the cadherin family,responsible for the disruption of desmosomes leading to the acantholysis phenomenon.Two main classical subtypes of pemphigus have been individualized:pemphigus vulgaris and foliaceus,in which pathogenic autoantibodies are directed against desmoglein 3 and 1 respectively.The knowledge about B-cell populations responsible for pemphigus activity increased a lot.In pemphigus patients,B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins,directly responsible for disease activity,and regulatory B lymphocytes.After rituximab treatment,clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells,whereas clinical remission was associated with a change in B-cell populations,as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment,with an increase of immatures and transitional B-cells producing IL-10.The mechanisms leading to autoreactive B-cells appearance,the precise role of B-reg in immune tolerance and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered.Polymorphonuclear neutrophil granulocytes(PMN) are the first responders of the immune system to threats by invading microorganisms.Since 2004, PMN were shown to produce neutrophil extracellular traps(NET),structures consisting of decondensed chromatin embedded with histones,granular and cytoplasmic proteins that trap and kill microbes.In lupus recent works demonstrated evidences that NETs components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.Besides lupus,other works showed evidence of NETs implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.The hypotheses is that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NETs components.The aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by NET.

Read the detailed description

Pemphigus is a rare autoimmune disease involving skin and mucous membranes with an incidence estimated as 0.7 to 7 new cases per million per year, responsible for non-negligible morbidity and mortality. Pemphigus is characterized by the production of pathogenic autoantibodies directed against two desmosomal proteins involved in keratinocyte adhesion (i.e. desmoglein 1 and desmoglein 3). These antibodies are responsible for the disruption of desmosomes leading to the acantholysis phenomenon, which results in the formation of skin and mucosal blisters. Two main classical subtypes of pemphigus have been individualized, pemphigus vulgaris (PV) and pemphigus foliaceus (PF), in which pathogenic autoantibodies are directed against desmosomal transmembrane glycoproteins belonging to the cadherin family, desmoglein 3, and desmoglein 1, respectively. As for many auto-immune diseases, high doses of corticosteroids (CS) remained the mainstay of first-line treatment for long time, alone or in conjunction with immunosuppressants. However, on these regimens, frequent relapses occurs when tapering CS dosage leading to long-term treatment and its associated risk of CS side effects.

Since ten years, the improvement in the knowledge of B-cell activation and survival, as well as their direct implication in auto-immune disease such as pemphigus through pathogenic auto-antibodies production, led to the identification of new therapeutic targets. New biological therapies based on B cell depletion were developed in severe autoimmune disorders, notably in pemphigus.

Several teams demonstrated the safety and efficacy of Rituximab, a chimeric immunoglobulin gamma-1(IgG1) monoclonal antibody(mAb) targeting the cluster of differentiation antigen 20(CD20) molecule expressed by normal B-cells from pre-B cells except for plasma cells, in severe pemphigus refractory to corticosteroids as well as in first line of treatment. Across these works, some of them concurred to improve the knowledge about B-cell populations responsible for pemphigus activity. In pemphigus patients, B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins, directly responsible for disease activity, and regulatory B lymphocytes (B-reg). After rituximab treatment of pemphigus patients, clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells, whereas clinical remission was associated with a change in B-cell populations, as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment, with an increase of immatures and transitional B-cells producing IL-10 (B-reg).

The mechanisms leading to autoreactive B-cells appearance, the precise role of B-reg in immune tolerance, and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered. As for other auto-immune diseases, first flares and relapses were described following infectious events. Thus, infectious agents might trigger unknown mechanisms participating in the immune system imbalance by the activation of previously quiescent auto reactive B-cells or effector B-cells.

Polymorphonuclear neutrophil granulocytes (PMN) are the first responders of the immune system to threats by invading microorganisms; performing essential functions of innate immunity in host defence against a broad range of pathogens, notably by phagocytosis, intracellular degradation and extracellular discharge of antimicrobial factors. Since 2004, Polynuclear Neutral Neutrophil (PNN) were shown to produce neutrophil extracellular traps (NET), structures consisting of decondensed chromatin embedded with histones, granular and cytoplasmic proteins that trap and kill microbes. NET were initially consider to arise following cell death (NETosis) but NET formation was also described without PMN death with mitochondrial DNA extrusion. NET production during infectious events is responsible for the release of cytosolic, nuclear and mitochondrial antigens in the extracellular environment; this auto-antigen exposure constituting favourable conditions for autoimmune disease such as lupus erythematosus and AntiNeutrophil Cytoplasmic Antibody (ANCA) vasculitis, of which auto-antibodies targets belong to NET components (DNA, RNA, MPO, PR3). Besides antimicrobial function, an excessive production of NET or NET insufficient clearance were found to maintain tissue inflammation and excessive tissue damages that contribute to autoinflammatory and autoimmune diseases.

In lupus, recent works demonstrated evidences that NET components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.

Besides lupus, other works showed evidence of NET implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.

The investigators hypothesize that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NET components, as it is the case for lupus (DNA, RNA, LL37), Rheumatoid Arthritis(RA) (citrullinated proteins) or small vessel vasculitis (PR3, MPO).

Thus, the primary aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by neutrophil extracellular traps.

The secondary aim is to compare the results obtained in pemphigus patients to patients with other autoimmune diseases such as lupus, rheumatoid arthritis a Gougerot-Sjögren syndrome.

02

Conditions studied

  • Pemphigus Vulgaris
  • Pemphigus Foliaceus

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Keywords

  • Pemphigus Vulgaris
  • Pemphigus Foliaceus
  • B-cell
  • Dermatology
03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's planned enrollment of 40 is above the median of 30 across 53 interventional studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients man or woman
  • Patients above 18 years old
  • Patients fulfilling the diagnostic criteria for pemphigus (Lever et al, 1979), or for lupus (SLICC 2012), or for rheumatoid arthritis (ACR / EULAR 2009 criteria), or for Gougerot-Sjögren's syndrome (ACR criteria / EULAR 2016)
  • Clinically active disease, defined by the presence of erosions or cutaneo-mucous bubbles for pemphigus, a SLEDAI score> 0 for lupus, a DAS28> 0 score for rheumatoid arthritis, and an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score> 0 for Gougerot-Sjögren's syndrome
  • Patients consenting to participate in the study
  • Patients benefiting from the national healthcare insurance

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating woman
  • Patient already treated with biotherapy
  • Patient already receiving treatment that may affect lymphocyte B populations: therapy> 10 mg / d or other .
  • Patient whose weight and / or level does not allow an additional blood sample during the assessment already provided by the treatment (according to the values in Appendix 2 of the Decree of April 12, 2018, which lists the research mentioned in 2 ° of Article L. 1121-1 of the Public Health Code)
  • Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    Pemphigus or other autoimmune diseases.

    Other: Blood sample

Interventions

  • OtherBlood sample

    Collection of 2 blood sample : The first one at the inclusion in the study, the second one between 6 months and 9 months after the inclusion. The sample consists of 2 tubes of EthyleneDiamineTetraAcetic (EDTA) of 7 mL.

06

What researchers measure

Primary outcomes

  1. Involvement of neutrophil extracellular traps (NETs) in the activation of B lymphocytes in Pemphigus

    This primary outcome measure is composite. It will be verified according to the following points : Measurement of activation parameters of total, auto-reactive, and regulator B lymphocytes of patients : * Quantification of membrane markers for activation of B lymphocytes (CD80, CD86, CD40) * Quantification of the production of pro-inflammatory cytokines (IL-6, IL-8, Tumor Necrosis Factor alpha (TNF alpha), IFNγ) by total and auto-reactive B lymphocytes * Quantification of the total production of immunoglobulins and antibodies specific for the disease * Quantification of IL-10 and Tumor Growth Factor (TGF) beta production by regulatory B cells.

    Time frame: 9 months after inclusion

Secondary outcomes

  1. Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also in lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on membrane markers for activation of B lymphocytes

    Quantification of membrane markers for activation of B lymphocytes (CD80, Cluster of Differentiation antigen 86 (CD86), CD40);

    Time frame: 9 months after inclusion

  2. Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on pro-inflammatory cytokines

    Quantification of the production of pro-inflammatory cytokines (IL-6, IL-8, TNF-alpha(Tumor Necrosis Factor alpha), IFNγ) by total and auto-reactive B lymphocytes

    Time frame: 9 months after inclusion

  3. Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also in lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on immunoglobulins and antibodies

    Quantification of the total production of immunoglobulins and antibodies specific for the disease

    Time frame: 9 months after inclusion

  4. Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus,is also in lupus,rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on IL-10 and TGFbeta production by regulatory B cells

    Quantification of IL-10 and TGFbeta production by regulatory B cells

    Time frame: 9 months after inclusion

07

Study locations

1 of 1 sites recruiting
  • Pr Philippe MUSETTE - Hôpital AVICENNE
    Bobigny, 93000, France
    Recruiting
08

References and documents

Publications

  • Langan SM, Smeeth L, Hubbard R, Fleming KM, Smith CJ, West J. Bullous pemphigoid and pemphigus vulgaris--incidence and mortality in the UK: population based cohort study. BMJ. 2008 Jul 9;337(7662):a180. doi: 10.1136/bmj.a180. PubMed 18614511 ↗
  • Hashimoto T, Amagai M, Garrod DR, Nishikawa T. Immunofluorescence and immunoblot studies on the reactivity of pemphigus vulgaris and pemphigus foliaceus sera with desmoglein 3 and desmoglein 1. Epithelial Cell Biol. 1995;4(2):63-9. PubMed 8688919 ↗
  • Martel P, Joly P. Pemphigus: autoimmune diseases of keratinocyte's adhesion molecules. Clin Dermatol. 2001 Nov-Dec;19(6):662-74. doi: 10.1016/s0738-081x(00)00191-7. No abstract available. PubMed 11705674 ↗
  • Amagai M, Tsunoda K, Zillikens D, Nagai T, Nishikawa T. The clinical phenotype of pemphigus is defined by the anti-desmoglein autoantibody profile. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):167-70. doi: 10.1016/s0190-9622(99)70183-0. PubMed 10025740 ↗
  • Mahoney MG, Wang Z, Rothenberger K, Koch PJ, Amagai M, Stanley JR. Explanations for the clinical and microscopic localization of lesions in pemphigus foliaceus and vulgaris. J Clin Invest. 1999 Feb;103(4):461-8. doi: 10.1172/JCI5252. PubMed 10021453 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04117529
Responsible party
Sponsor
First posted
Oct 7, 2019
Start date
Oct 22, 2019
Primary completion
Jul 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
Jan 8, 2021

Study contacts

Mohammed RAHAOUI, Mr
Contact
mohammed.rahaoui@aphp.fr
+33148955977
Gérôme BOHELAY, Dr
Contact
gerome.bohelay@gmail.com
+33148955189
Philippe MUSETTE, Pr
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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