Autophagy Dysfunction in Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) Clinical Trial

— AUTOPH-HS  

Official title:

Autophagy Dysfunction in Hidradenitis Suppurativa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05723757
• Other study ID #: 2022-A01516-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Association pour la Recherche Clinique et Immunologique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Intervention

Diagnostic Test:
• blood sampling
Draw a 8.5mL blood sample for detection of SNPs of genomic origin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Association pour la Recherche Clinique et Immunologique

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 0
Secondary	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)	Day 0
Secondary	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).	Day 0