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Autophagy Dysfunction in Hidradenitis Suppurativa (AUTOPH-HS)

Primary Purpose

Hidradenitis Suppurativa (HS)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood sampling
Sponsored by
Association pour la Recherche Clinique et Immunologique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hidradenitis Suppurativa (HS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject aged 18 to 65 years (included) Subject diagnosed with HS for at least 1 year Subject diagnosed with moderate-to-severe HS defined by HS PGA≥3 Subject presenting an HS with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses Subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses) Subject able to read, understand and give documented informed consent Subject willing and able to comply with the protocol requirements for the duration of the study Subject with health insurance coverage according to local regulations Exclusion Criteria: - Pregnancy or breast-feeding women Subject currently experiencing or having a history of other concomitant skin or systemic inflammatory conditions that could constitute a bias (i.e. psoriasis, Crohn's Disease, etc.) Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk Linguistic or mentally incapacity to sign the consent form Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated) Subject in an exclusion period from a previous study or who is participating in another clinical trial using a drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HS Patients

    Arm Description

    50 adult subjects suffering from moderate to severe HS, aged 18 to 65, diagnosed for at least 1 year

    Outcomes

    Primary Outcome Measures

    Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency
    Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency in a cohort of moderate-to-severe HS patients The prevalence of these SNPs will be compared with the prevalence observed in a population suffering from Crohn's Diseases (Ellinghaus et al., 2013).

    Secondary Outcome Measures

    Prevalence of 100 SNPs in somatic DNA (skin) associated with autophagy deficiency in a cohort of moderate-to-severe HS patients
    The prevalence of these SNPs will be compared with the prevalence of SNPs in genomic DNA (blood) Prevalence of 100 SNPs associated with autophagy deficiency in genomic DNA (blood) and somatic DNA (skin)
    Prevalence of 100 SNPs in genomic DNA (blood) and somatic DNA (Skin) associated with autophagy deficiency according to severity of disease.
    Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency according to severity of disease. The severity of HS disease will be evaluated through clinical scores (HS PGA scale, IH-S4 score, Hurley stage or refined Hurley) or quality of life score (DLQI). Prevalence of 100 SNPs in somatic DNA (skin) associated with autophagy deficiency according to severity of disease. The severity of HS disease will be evaluated through clinical scores (HS PGA scale, IH-S4 score, Hurley stage or refined Hurley) or quality of life score (DLQI). Prevalence of 100 SNPs associated with autophagy deficiency in genomic DNA (blood) and somatic DNA (skin), according to severity of disease. The severity of HS disease will be evaluated through clinical scores (HS PGA scale, IH-S4 score, Hurley stage or refined Hurley) or quality of life score (DLQI).

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 9, 2023
    Sponsor
    Association pour la Recherche Clinique et Immunologique
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05723757
    Brief Title
    Autophagy Dysfunction in Hidradenitis Suppurativa
    Acronym
    AUTOPH-HS
    Official Title
    Autophagy Dysfunction in Hidradenitis Suppurativa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Association pour la Recherche Clinique et Immunologique

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The pathogenesis of HS is still poorly understood: the pilosebaceous tropism and the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggest the involvement of 3 factors that would be intimately linked: the presence of (i) a microbial dysbiosis, (ii) a dysfunction of the pilosebaceous apparatus and (iii) an inappropriate immune response. But how these 3 elements interact with each other remains unestablished, with few studies that have analyzed them from a kinetic point of view. Beyond a possible dysfunction of the pilosebaceous apparatus, we hypothesize a bacterial dysbiosis in connection with abnormalities of autophagy function with secondary development of an inappropriate immune response. Because of its functions of bacterial clearance and activation of local immune response, a defect in the autophagic process may be associated with the development of inflammatory pathologies related to microbial dysbiosis. Crohn's disease (CD), an inflammatory pathology of the gastrointestinal tract associated with intestinal dysbiosis, has been associated with alterations in autophagy, with approximately 50% of patients having single nucleotide polymorphisms (SNPs) associated with autophagy deficiency (Ellinghaus et al., 2013). The epidemiological association of CD/HS, the presence of skin dysbiosis and a chronic inflammatory response during HS, make us suspect a deficit of autophagic function in these patients, in a similar way to what is observed during Crohn's disease. The aim of this study is to analyze the frequency of 100 SNPs, reported to be associated with autophagy deficiency, in a cohort of moderate-to-severe HS patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa (HS)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is an exploratory, intra-individual, prospective, mono-site study. This study is a category 2 study (interventional research with minimal risks and constraints).
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HS Patients
    Arm Type
    Experimental
    Arm Description
    50 adult subjects suffering from moderate to severe HS, aged 18 to 65, diagnosed for at least 1 year
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    blood sampling
    Intervention Description
    Draw a 8.5mL blood sample for detection of SNPs of genomic origin
    Primary Outcome Measure Information:
    Title
    Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency
    Description
    Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency in a cohort of moderate-to-severe HS patients The prevalence of these SNPs will be compared with the prevalence observed in a population suffering from Crohn's Diseases (Ellinghaus et al., 2013).
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    Prevalence of 100 SNPs in somatic DNA (skin) associated with autophagy deficiency in a cohort of moderate-to-severe HS patients
    Description
    The prevalence of these SNPs will be compared with the prevalence of SNPs in genomic DNA (blood) Prevalence of 100 SNPs associated with autophagy deficiency in genomic DNA (blood) and somatic DNA (skin)
    Time Frame
    Day 0
    Title
    Prevalence of 100 SNPs in genomic DNA (blood) and somatic DNA (Skin) associated with autophagy deficiency according to severity of disease.
    Description
    Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency according to severity of disease. The severity of HS disease will be evaluated through clinical scores (HS PGA scale, IH-S4 score, Hurley stage or refined Hurley) or quality of life score (DLQI). Prevalence of 100 SNPs in somatic DNA (skin) associated with autophagy deficiency according to severity of disease. The severity of HS disease will be evaluated through clinical scores (HS PGA scale, IH-S4 score, Hurley stage or refined Hurley) or quality of life score (DLQI). Prevalence of 100 SNPs associated with autophagy deficiency in genomic DNA (blood) and somatic DNA (skin), according to severity of disease. The severity of HS disease will be evaluated through clinical scores (HS PGA scale, IH-S4 score, Hurley stage or refined Hurley) or quality of life score (DLQI).
    Time Frame
    Day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject aged 18 to 65 years (included) Subject diagnosed with HS for at least 1 year Subject diagnosed with moderate-to-severe HS defined by HS PGA≥3 Subject presenting an HS with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses Subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses) Subject able to read, understand and give documented informed consent Subject willing and able to comply with the protocol requirements for the duration of the study Subject with health insurance coverage according to local regulations Exclusion Criteria: - Pregnancy or breast-feeding women Subject currently experiencing or having a history of other concomitant skin or systemic inflammatory conditions that could constitute a bias (i.e. psoriasis, Crohn's Disease, etc.) Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk Linguistic or mentally incapacity to sign the consent form Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated) Subject in an exclusion period from a previous study or who is participating in another clinical trial using a drug

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Autophagy Dysfunction in Hidradenitis Suppurativa

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