- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05735925
The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis (VERIMMUNE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this exploratory study is to analyze the interplay between microbiota and the innate and adaptative immune response in the pathogenesis of HS. To better understand this host-microbiota interplay, we will assess the number, frequency and functional phenotypes of the different lymphocyte subsets in HS patients, with a special focus regarding the UL. In the same time, we will assess the diversity and nature of skin microbiota of the same patients. Finally, we will explore the relation between the immune response and the skin microbiota in HS, using correlation analysis (Spearman coefficient).
In this study, HS patients will be their own control for leucocyte phenotyping, cytokine analysis and T Cells Receptor (TCR) sequencing (skin biopsies) and for skin microbiota analysis. Paired (age/sex) healthy volunteers will be controls for gut microbiota analysis and for immunophenotyping of circulating leukocytes (Peripheral Blood Mononuclear Cells (PBMC) analysis).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie GILIBERT, PhD
- Phone Number: +33 6 65 37 50 08
- Email: sophie.gilibert@lyonrechercheclinique.com
Study Locations
-
-
Rhône
-
Lyon, Rhône, France, 69003
- Department of Dermatology-Hôpital Edouard Herriot
-
Contact:
- Axel VILLANI, M.D Ph.D
- Phone Number: 04 72 11 72 11
- Email: axel.villani@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- For woman with childbearing potential, negative pregnancy test at the inclusion visit Specific criteria for HS patients
- Subject diagnosed with HS for at least 6 months
- 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)
Exclusion Criteria:
- Pregnancy or breast-feeding women
- Subject treated by allergen immunotherapy within 4 weeks before inclusion
- Subject treated by Non-Steroidal Anti-Inflammatory Drugs (NSAID), antibiotics or proton-pump inhibitors within 4 weeks before inclusion
- Subject treated by live (attenuated) vaccine within 4 weeks before inclusion
- Subject treated by anti-viral treatment within 4 weeks before inclusion
- Subject treated by anti-diarrhea treatment including, but not limited to Loperamide
- Subject treated by immunosuppressive/immunomodulatory substances including oral corticosteroid or biological agents within 4 weeks before inclusion
- Subject presenting spondylo-arthritis or Inflammatory Bowel Disease (IBD)
- Subject with a Body Mass Index (BMI)<18.5 or BMI>35
- Subject consuming probiotics or using a specific diet (e.g. gluten free, vegetarian, vegan, intermittent fasting)
- 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 Specific criteria for HS patients
- Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of HS
- History of allergic reaction to local anesthetic product
- History of wound healing disorders (e.g. hypertrophic scars, keloids)
- History of extensive armpit surgery
- Subject with known active infection to Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
- Subject treated for their HS by systemic therapy, investigational or commercial, approved or off label)
- Subject treated for their HS by immunosuppressants or intralesional corticosteroids within 4 weeks before the inclusion
- Subject treated for their HS by topical antibiotics within 4 weeks before the inclusion
- Subject previously treated with monoclonal antibodies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hidradenitis Suppurativa (HS) Patients
a 6-mm and a 4-mm section skin biopsies on a lesional area (inflammatory nodules) a 6-mm and a 4-mm section skin biopsies on a non lesional area - blood sample (16 mL) |
These intervention will be necessary to phenotype the immune cells that are present in the skin and blood of HS patients
|
No Intervention: Healthy Subjects
blood sample (16 mL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of the different leucocytes subsets
Time Frame: Day 0
|
Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
|
Day 0
|
Frequency of the different leucocytes subsets
Time Frame: Day 0
|
Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
|
Day 0
|
Functional phenotype of the different leucocytes subsets
Time Frame: Day 0
|
Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative RNA
Time Frame: Day 0
|
Quantitative RNA expression of selected cytokines' genes in the lesional skin versus non lesional skin
|
Day 0
|
TCR Sequencing
Time Frame: Day 0
|
TCR sequencing in the lesional skin versus non-lesional skin
|
Day 0
|
Bacterial diversity
Time Frame: Day 0
|
Bacterial diversity of microbes from skin flora in lesional skin versus non lesional skin
|
Day 0
|
Bacterial abundance
Time Frame: Day 0
|
Bacterial abundance of microbes from skin flora in lesional skin versus non lesional skin
|
Day 0
|
Bacterial diversity
Time Frame: Day 14
|
Bacterial diversity of microbes from gut flora in HS patients versus healthy volunteers
|
Day 14
|
Bacterial abundance
Time Frame: Day 14
|
Bacterial abundance of microbes from gut flora in HS patients versus healthy volunteers
|
Day 14
|
Presence of bacterial DNA translocation
Time Frame: Day 0
|
Presence of bacterial DNA translocation in the blood of HS patients
|
Day 0
|
Description of bacterial DNA translocation
Time Frame: Day 0
|
Genus, phyla, species, specific bacteria abundance and overall diversity in the blood of HS patients
|
Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A02408-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hidradenitis Suppurativa (HS)
-
Yale UniversityNot yet recruitingHidradenitis Suppurativa | Hidradenitis Suppurativa, Acne Inversa | Hidradenitis Suppurativa \(HS\)United States
-
Boehringer IngelheimRecruiting
-
Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Canada, Bulgaria, Italy, Spain, Germany, Poland, France, Australia, Denmark, United Kingdom
-
Novartis PharmaceuticalsAvailableHidradenitis Suppurativa (HS)
-
AbbVie (prior sponsor, Abbott)CompletedHidradenitis Suppurativa (HS)
-
InflaRx GmbHQuintiles, Inc.CompletedHidradenitis Suppurativa (HS)United States, Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland
-
Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Canada, Czechia, Spain, Germany, Poland, Netherlands, Belgium, France, Greece, Japan, Austria
-
Incyte CorporationRecruitingHidradenitis Suppurativa (HS)United States, Austria, Belgium, Canada, Germany, Poland, Spain, Australia, Denmark, France, United Kingdom, Japan, Bulgaria, Netherlands, Czechia, Greece, Italy
-
Association pour la Recherche Clinique et ImmunologiqueNot yet recruitingHidradenitis Suppurativa (HS)
-
AbbVieCompletedHidradenitis Suppurativa (HS)United States, Canada, Japan, Puerto Rico
Clinical Trials on Skin Swab & Skin Biopsies & Blood Sample
-
University Hospital, BrestNot yet recruitingPruritus | Chronic Pruritus | ItchFrance
-
Institut PasteurJanssen Biotech, Inc.Recruiting
-
Case Comprehensive Cancer CenterActive, not recruitingInvasive Breast Cancer | DCISUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedIntestinal Epithelial Dysplasia | Tufting EnteropathyFrance
-
Henry Ford Health SystemM.D. Anderson Cancer CenterCompleted
-
Institut de Cancérologie de LorraineCompletedFibrosis | Breast CarcinomaFrance
-
Pierre Fabre Dermo CosmetiqueInstitut National de la Santé Et de la Recherche Médicale, France; Centre National...Completed
-
Hospices Civils de LyonRecruiting
-
University Hospital, LilleGlaxoSmithKlineUnknownSystemic Sclerosis | Systemic SclerodermaFrance
-
Poitiers University HospitalRecruitingImmune Response | Staphylococcus Aureus | Atopic Dermatitis | Cytokines | Bacterial Toxins | T Cells SubsetsFrance