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Autophagy Dysfunction in Hidradenitis Suppurativa (AUTOPH-HS)

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ClinicalTrials.gov Identifier: NCT05723757
Recruitment Status : Not yet recruiting
First Posted : February 13, 2023
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Association pour la Recherche Clinique et Immunologique

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa (HS) Diagnostic Test: blood sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Autophagy Dysfunction in Hidradenitis Suppurativa
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HS Patients
50 adult subjects suffering from moderate to severe HS, aged 18 to 65, diagnosed for at least 1 year
 Diagnostic Test: blood sampling
Draw a 8.5mL blood sample for detection of SNPs of genomic origin


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of 100 SNPs in genomic DNA (blood) associated with autophagy deficiency [ Time Frame: Day 0 ]
    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 :
  1. Prevalence of 100 SNPs in somatic DNA (skin) associated with autophagy deficiency in a cohort of moderate-to-severe HS patients [ Time Frame: Day 0 ]
    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)

  2. Prevalence of 100 SNPs in genomic DNA (blood) and somatic DNA (Skin) associated with autophagy deficiency according to severity of disease. [ Time Frame: Day 0 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Association pour la Recherche Clinique et Immunologique
ClinicalTrials.gov Identifier: NCT05723757    
Other Study ID Numbers: 2022-A01516-37
First Posted: February 13, 2023    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration