Hidradenitis Suppurativa (HS)

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Review clinical trials related to Hidradenitis Suppurativa (HS). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa

Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa

Participants needed: 25
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Corvus Pharmaceuticals, Inc.Updated: Oct 13, 2026Locations: 11
Eligibility criteria

Adult male or female, ≥18 years of age at the time of signing the informed conse... [+6]

Currently experiencing, or previous history of, other concomitant skin condition... [+4]

Status: Recruiting

Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

This study investigates the efficacy of topical roflumilast foam in patients with HS.

Participants needed: 10
Trial details
Phase: Phase 2Age: 12+Biological sex: AllType: InterventionalSponsor: Harrison DermatologyUpdated: Oct 13, 2026Locations: 1
Eligibility criteria

Male or female subjects aged 12 years or older at time of consent (or assent). [+7]

Medical condition or physical examination abnormality that would prevent study p... [+16]

Status: Recruiting

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.

Participants needed: 40
Trial details
Phase: Phase 2Age: 12-17Biological sex: AllType: InterventionalSponsor: Incyte CorporationUpdated: Oct 9, 2026Locations: 30
Eligibility criteria

Aged ≥ 12 to < 18 years at the time of informed consent/assent signing. [+8]

Presence of > 20 draining tunnels (fistulas) at either the screening or baseline... [+4]

Status: Recruiting

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

Participants needed: 600
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Incyte CorporationUpdated: Oct 9, 2026Locations: 296
Eligibility criteria

Ability to comprehend and willingness to sign a written ICF for the study. [+5]

Had been permanently discontinued from study treatment during the parent study. [+8]

Status: Recruiting

Global Healthcare Study on Hidradenitis Suppurativa

The Global Healthcare Study on Hidradenitis Suppurativa (GHSHS) is an international, multicenter observational study hosted by the University of Zurich (UZH) investigating healthcare access, treatment patterns, disease severity, and quality of life in patients with hidradenitis suppurativa. The study collects standardized clinical data from routine medical records to identify disparities in healthcare delivery and outcomes across different healthcare systems.

Participants needed: 9,600
Trial details
Age: 14+Biological sex: AllType: ObservationalSponsor: Julia Tatjana MaulUpdated: Sep 28, 2026Locations: 1Duration: 5 Years
Eligibility criteria

Signed General Consent Form, or equivalent document [+1]

Inability to provide informed consent. [+1]

Status: Recruiting

ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa

This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.

Participants needed: 200
Trial details
Phase: Phase 2Age: 18-79Biological sex: AllType: InterventionalSponsor: Oruka Therapeutics, Inc.Updated: Sep 24, 2026Locations: 15
Eligibility criteria

Has signs and symptoms of HS for at least 6 months; [+2]

Presence of any other active skin disease or condition that may interfere with t... [+1]

Status: Not yet recruiting

Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa

This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease hidradenitis suppurativa (HS). In this study, the investigators will extend data from a 12-week pilot study to rigorously test the hypothesis that botulinum toxin (BoNT) therapy reduces disease severity and relieves HS pain symptoms..

Participants needed: 40
Trial details
Phase: Phase 2Age: 13-75Biological sex: AllType: InterventionalSponsor: University of Massachusetts, WorcesterUpdated: Sep 10, 2026Locations: 1
Eligibility criteria

Age >13 and <75 [+7]

pregnant or breastfeeding [+11]

Status: Not yet recruiting

An Observational Study of Patients With Dermatologic Disease

TARGET-DERM+ is an observational research study to conduct a comprehensive review of outcomes for patients with dermatologic disease (DD) and providers who treat these patients. The study includes patients managed for DD of any etiology in usual clinical practice in the United States and addresses important clinical questions regarding the management of DD by collecting and analyzing data from patients at academic medical centers and community medical practices and/or data from providers who treat them.

Participants needed: 2,000,000
Trial details
Biological sex: AllType: ObservationalSponsor: Target PharmaSolutions, Inc.Updated: Sep 10, 2026Locations: 1Duration: 15 Years
Eligibility criteria

Adult or pediatric participants managed for DD invited to participate OR a provi... [+1]

Participant withdrew consent; Failure to complete activities as required per the...

Status: Recruiting

Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

This is a post-approval commitment study to evaluate efficacy, and safety of two dosing regimens of secukinumab (AIN457), 300 mg every four weeks (Q4W) and every two weeks (Q2W), in Chinese adult patients with moderate to severe hidradenitis suppurativa (HS).

Participants needed: 36
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Sep 9, 2026Locations: 10
Eligibility criteria

Signed informed consent must be obtained before any assessment is performed. [+4]

Total fistulae count ≥ 20 at baseline. [+6]

Status: Not yet recruiting

Urinary Bladder Matrix (UBM) Registry

The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products. The study will evaluate patient characteristics, treatment patterns, and clinical outcomes to better understand how UBM products are used in routine clinical practice and the outcomes experienced by patients over time.

Participants needed: 300
Trial details
Age: 21+Biological sex: AllType: ObservationalSponsor: Integra LifeSciences CorporationUpdated: Sep 4, 2026Duration: 12 Months
Eligibility criteria

Adults aged ≥21 years at the time of initial urinary bladder matrix (UBM) produc... [+2]

Wound treated with a skin substitute prior to UBM treatment. [+4]

Status: Not yet recruiting

Skin-in-Sight: a Longitudinal Cohort Infrastructure for Standardized Remote Monitoring and the Evaluation of Digital Care Innovations in Chronic Skin Diseases

Psoriasis, atopic dermatitis (eczema) and hidradenitis suppurativa are long-term skin conditions that flare and settle over time. Most of what happens to the skin happens at home, between hospital appointments. A dermatologist usually sees the skin only on the day of the visit, which may not reflect how the condition has been over the preceding months. This study sets up a long-term research collection, called a cohort, in which people with one of these three conditions take part from home. Once a month, participants use a certified digital health app on their own phone to answer a short set of questions about their symptoms and about how their skin affects daily life, and to take a standard set of photographs of their skin. Twice a year they answer a longer set of questions. Taking part takes about five minutes in most months and about twenty-five minutes twice a year. The app gives step-by-step guidance on lighting, distance and framing at the start of every photo session, so that the photographs can be compared from month to month. The photographs are reviewed by trained assessors, who score how severe the skin disease looks using the scoring systems established in dermatology research. Three assessors score each set of photographs independently, and their scores are combined according to rules that are set in advance. With the participant's permission, this information is combined with information already recorded during routine care, such as changes in treatment and hospital visits; with pharmacy records showing which medicines were dispensed; and with publicly available daily measurements of air quality, sunshine, ultraviolet radiation and pollen for the area where the participant lives. Bringing these together makes it possible to study how these conditions change over time, what happens in the period before a flare, and how treatment and the living environment relate to the course of the disease. The collected data are also intended to support the development of computer-based tools that could in future help assess skin disease from photographs. Taking part does not change the care a participant receives. The study does not provide medical advice, and the data collected are not used for diagnosis, treatment decisions or routine follow-up. Participants who experience worsening symptoms contact their treating physician as usual. The cohort is also designed so that studies of digital care tools can later be carried out within it, among participants who have agreed in advance to be approached. Each of those studies is registered separately.

Participants needed: 1,000
Trial details
Age: 16+Biological sex: AllType: ObservationalSponsor: Medisch Spectrum TwenteUpdated: Sep 4, 2026Locations: 3Duration: 2 Years
Eligibility criteria

Diagnosis of a chronic inflammatory skin disease (psoriasis, atopic dermatitis,... [+3]

The patient has insufficient command of the Dutch language resulting in the insu...

Status: Recruiting

A Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-002-158 Tablets in Chinese Adult Patients With Hidradenitis Suppurativa

This study is a Phase Ic/II clinical trial conducted in Chinese patients with moderate-to-severe hidradenitis suppurativa (HS), aiming to evaluate the safety and efficacy of LT-002-158 tablets in the treatment of moderate-to-severe HS. The study consists of two parts. The Phase Ic portion employs an open-label, single-arm design to primarily investigate the safety and tolerability of LT-002-158 tablets in patients with moderate-to-severe HS. The Phase II study adopts a randomized, double-blind, placebo-controlled, parallel-group design, with an open-label, single-arm extension phase, to primarily assess the therapeutic efficacy of LT-002-158 tablets in patients with moderate-to-severe HS.

Participants needed: 12
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.Updated: Aug 27, 2026Locations: 1
Eligibility criteria

Male or female aged 18 to 75 years (inclusive), with body mass index (BMI) betwe... [+6]

Presence of >20 fistulas or deeply extensive coalescing lesions; [+17]

Status: Not yet recruiting

A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)

This Phase 2 study will test whether the investigational medicine, SPY072, improves hidradenitis suppurativa (HS) in adults with moderate to severe disease receiving advanced standard of care treatment. About 150 participants will be assigned by chance to receive either SPY072 or placebo for 16 weeks. Participants will be followed after the treatment period to evaluate safety and how long treatment effects may last.

Participants needed: 150
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Spyre Therapeutics, Inc.Updated: Aug 14, 2026Locations: 12
Eligibility criteria

Clinical diagnosis of Hidradenitis Suppurativa with symptoms for at least 6 mont... [+3]

More than 20 draining tunnels at screening or Day 1. [+2]

Status: Recruiting

Exploration of Brain Functional Networks in Patients With Hidradenitis Suppurativa Using fMRI

The goal of this observational study is to learn whether adults with hidradenitis suppurativa (HS) have changes in resting brain activity and how these changes are related to disease severity, pain, sleep, mood, and quality of life. The study will also examine whether brain activity changes after patients receive biologic or small-molecule treatment as part of their regular medical care. The main questions it aims to answer are: * Are resting brain activity patterns different between people with HS and healthy participants? * Are these brain activity patterns related to HS severity, pain, sleep problems, anxiety, depression, and quality of life? * Do brain activity patterns change after 3 months of routine treatment, and are these changes related to improvement in HS symptoms? Researchers will compare participants with HS with healthy participants of similar age and sex. A subgroup of participants with HS who receive biologic or small-molecule treatment as part of routine clinical care will also be assessed before and after treatment. Participants may: * Complete assessments of HS severity, pain, sleep, mood, and quality of life * Undergo resting-state functional magnetic resonance imaging * Undergo skin ultrasound and routine laboratory testing * Allow photographs of affected skin areas to be taken * Return for follow-up assessments for up to 3 months

Participants needed: 80
Trial details
Age: 18-45Biological sex: AllType: ObservationalSponsor: Second Xiangya Hospital of Central South UniversityUpdated: Aug 10, 2026Locations: 1
Eligibility criteria

Aged 18 to 45 years. [+15]

Participation in another investigational drug study within 1 month before enroll... [+10]

Status: Recruiting

A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa

The main objective of this study is to determine if NAV-240 works more effectively than a dummy treatment (placebo) for participants with moderate-to-severe HS. The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps (abscess and inflammatory nodule (AN) count) with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study). Participants will: * Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion). * Visit the clinic up to 9 times for checkups and tests over 22 weeks. * Complete a daily diary about their skin pain.

Participants needed: 150
Trial details
Phase: Phase 2Age: 18-70Biological sex: AllType: InterventionalSponsor: Navigator Medicines, Inc.Updated: Jul 22, 2026Locations: 41
Eligibility criteria

Diagnosis of stable HS for ≥ 2 months [+7]

> 20 draining tunnel count [+9]

Status: Recruiting

The Safety and Efficacy of Roflumilast Foam in HS

This study investigates the efficacy of topical roflumilast foam in patients with HS.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Beth Israel Deaconess Medical CenterUpdated: Jul 9, 2026Locations: 1
Eligibility criteria

Male or female subjects aged 18 years or older [+9]

Subjects with any medical condition or physical examination abnormality that wou... [+16]

Status: Not yet recruiting

FEcal tranSplantation in HidradeniTIs suppuratiVA : a piLot Study

The medical and surgical treatment of hidradenitis suppurativa (HS) remains difficult to date. The search for new therapies for HS is a major challenge. The pathophysiology of HS, the similarities with Crohn's disease and the data in the literature suggest a role for the digestive flora in HS. The role of the intestinal microbiota has now been clearly demonstrated in the pathophysiology of chronic inflammatory bowel disease (IBD), and is suspected in many other diseases. Fecal microbiota transplantation (FMT) is the gold-standard treatment for recurrent Clostridioides Difficile infection, and is being investigated in a wide range of conditions. Our hypothesis is that FMT would improve inflammatory lesions of HS by modifying patients' digestive microbiota. Translated with DeepL.com (free version)

Participants needed: 24
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, Clermont-FerrandUpdated: Jun 25, 2026Locations: 7
Eligibility criteria

Age ≥ 18 years [+3]

Allergy or contraindication to amoxicillin-clavulanic acid [+9]

Status: Recruiting

Pelashield™ PainGuard™ vs Restrata® in HS Surgery

Hidradenitis Suppurativa (HS) is a long-lasting skin condition that causes painful lumps and infections. In severe cases, patients need surgery to remove the affected skin. After surgery, a wound dressing called a wound matrix is placed over the area to help the skin heal. This study will compare two different wound matrices: Restrata®, which is the current standard treatment. Pelashield™ PainGuard™, a newer dressing that contains silver to reduce bacteria and lidocaine to help with pain. The goal of this research is to find out if Pelashield™ PainGuard™ helps patients heal better after surgery than Restrata®. We will look at: How quickly healthy granulation tissue (new healing tissue) forms How soon the wound is ready for the second surgery to apply a skin graft How often infections happen after surgery How much narcotic (opioid) pain medication patients need after surgery Patients who receive Pelashield™ PainGuard™ will be enrolled in the study going forward (prospective group). Patients who previously had surgery with Restrata® will be included through a review of their medical records (retrospective group). No additional procedures will be done outside of standard surgical care.

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Rutgers, The State University of New JerseyUpdated: May 22, 2026Locations: 1
Eligibility criteria

Adults (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surg... [+2]

Non-English-speaking patients (due to consent and follow-up communication limita... [+7]

Status: Recruiting

A Study With CIT-013 in HS Patients

The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are: Does CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS. Participants will: Take receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period

Participants needed: 96
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Citryll BVUpdated: May 22, 2026Locations: 28
Eligibility criteria

Male or female participants with HS of more than 6 months duration, [+5]

Prior treatment with a recombinant therapeutic protein during the 6 weeks before... [+3]

Status: Recruiting

Radiotherapy for Refractory Hidradenitis Suppurativa

The goal of this clinical trial is to learn if high-dose radiotherapy can provide sustained disease relief in moderate to severe, treatment resistant Hidradenitis suppurativa patients; could include any of the following: any sex/gender, and those greater then 18 years old. The main question\[s\] it aims to answer are: Outcome measure 1: Will radiotherapy change the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla? Outcome measure 2: Will radiotherapy positively change a patient's quality of life, pain levels and symptom burden? Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa. The contralateral axilla will not receive radiotherapy and will continue receiving the standard treatment regimen. Participants will... * Attend a baseline dermatology skin evaluation, complete multiple surveys and an optional participation in a biopsy * Attend multiple radiation sessions over 5 weeks * Attend 2 follow up visits with dermatology for skin evaluation, complete follow up surveys, and an optional biopsy.

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Thomas Jefferson UniversityUpdated: May 15, 2026Locations: 2
Eligibility criteria

Male or female subjects between the age of 18 or older with moderate or severe H... [+2]

Pregnancy - Women of childbearing potential must use trial approved birth contro... [+8]

Status: Not yet recruiting

Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis Suppurativa

The purpose of this study is to evaluate whether Alexandrite laser treatment is non-inferior to Nd:YAG (neodymium-doped yttrium aluminum garnet) laser treatment of hidradenitis suppurativa (HS).

Participants needed: 21
Trial details
Age: 12-75Biological sex: AllType: InterventionalSponsor: Geisinger ClinicUpdated: Apr 28, 2026
Eligibility criteria

Geisinger male or female patients with a diagnosis of hidradenitis suppurativa (... [+4]

Patients who cannot tolerate laser therapy [+2]

Status: Recruiting

Efficacy and Safety of SCT650C in Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Moderate to Severe Hidradenitis Suppurativa

Participants needed: 60
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Sinocelltech Ltd.Updated: Apr 28, 2026Locations: 1
Eligibility criteria

The participants must be at least 18 years of age at the time of signing the ICF... [+14]

Study participant has any medical or psychiatric condition could jeopardize or w... [+44]

Status: Not yet recruiting

A Single-center, Prospective, Self-controlled, Observational Real-world Study of the Efficacy and Safety of Anti-IL-17A/F Monoclonal Antibody Combined With Non-ablative Dot Laser for the Treatment of Mild to Moderate Hidradenitis Suppurativa

The goal of this clinical trial is to learn if combining an IL-17A/F monoclonal antibody with non-ablative fractional laser therapy works and is safe in patients with mild to moderate hidradenitis suppurativa (HS). The main questions it aims to answer are: Does the combination treatment reduce HS symptoms compared to before treatment? What are the main side effects of this combination treatment? Researchers will compare how participants feel and look after treatment to their own condition before treatment. Participants will: Get the combined treatment once every 4 weeks for 16 weeks Give skin and blood samples before the first treatment and at the last treatment visit Have a final check-up 8 weeks after the last treatment

Participants needed: 50
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Patients voluntarily participate in the study and sign the informed consent form... [+6]

Known allergy to the study drug or its excipients. [+7]

Status: Recruiting

A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.

Participants needed: 36
Trial details
Age: 18-71Biological sex: AllType: ObservationalSponsor: Sonoma Biotherapeutics, Inc.Updated: Apr 16, 2026Locations: 10
Eligibility criteria

Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics,... [+2]

Participation in the study is not in the subject's best interest, in the opinion...

Status: Not yet recruiting

MAIT Cells in Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) is a chronic, debilitating inflammatory skin disease characterized by painful, purulent lesions primarily in skin folds. Its pathogenesis remains poorly understood. The clinical benefit observed with both antibiotics and immunosuppressive therapies suggests HS may involve an abnormal immune response to skin microbiota. Mucosal-associated invariant T (MAIT) cells are immune cells that bridge innate and adaptive immunity and are known to regulate microbial flora. Dysfunctional MAIT cells have been implicated in autoimmune diseases such as type 1 diabetes, inflammatory bowel diseases, and psoriasis. Preliminary data from the VERIMMUNE study (NCT05735925) indicate that HS patients show a depletion of circulating MAIT cells and increased infiltration of CD8+ MAIT cells in lesions, associated with reduced activation and greater disease severity. These findings support the hypothesis that MAIT cell dysfunction plays a central role in HS and may serve as a biomarker for treatment response. This exploratory study aims to (Primary) characterize the phenotype and frequency of MAIT cell subsets in the skin and blood of HS patients compared to controls with other inflammatory skin diseases (psoriasis and back-acne); and to determine whether MAIT cell phenotype before treatment predicts clinical response to biologic agents. The study will recruit adults (18-65 years) with moderate-to-severe HS and matched controls with plaque psoriasis, or back-acne, or impetigo. All HS participants must be biologic-naïve at baseline and will be treated per national guidelines (adalimumab, secukinumab, or bimekizumab). No therapeutic intervention is imposed; patients are followed according to usual care. Skin and blood samples will be collected before and after treatment to assess immune profiles. To minimize bias HS patients will be age/sex-matched with controls; only patients with active, inflammatory HS lesions will be included; controls were selected to represent related yet distinct pathologies: back-acne (follicular but distinct mechanism), psoriasis (different lesion type, shared type-17 inflammation) and impetigo (skin bacterial infection). The Immunophenotyping strategy will use high-dimensional flow cytometry (Cytek® Aurora); researchers will analyze immune cell subsets (e.g., B cells, γδ T cells, NK cells, ILCs, MAIT, NK-T) in skin and blood. Specific markers for activation (CD69, PD-1, ICOS), differentiation (CCR7, CD45RA), proliferation (Ki-67), cytokine receptors, and chemokines will be assessed. The primary endpoint will be the frequency of MAIT cells in lesional vs. non-lesional skin and blood compared to controls before and after 12 weeks of biologic agent. The secondary endpoints will be changes in MAIT cell phenotype after 12 weeks of treatment, correlation with clinical improvement (defined by IHS4-55 response: ≥55% reduction in IHS4 score) and MAIT cell functions (assessed in vitro before and after treatment, anti-bacterial activity, capacity to proliferate and to be activated). This is a prospective, monocentric, exploratory study with intra-individual comparison and external active controls. The study falls under category 2 (interventional research with minimal risks). Clinical data, biopsy samples, and immune profiles will be collected before and after biologic therapy in moderate-to-severe HS patients (IHS4 ≥4), biologic-naïve, eligible for biologic agents treatment, with no antibiotics or immunosuppressive drugs in the prior month. The controls will be adults with psoriasis or back-acne or impetigo (no follow-up for control patients). This study has no direct therapeutic benefit for participants. However, it offers detailed clinical follow-up and may significantly improve understanding of HS pathogenesis. Known procedural risks (local anesthesia, biopsy, venipuncture) are minimal and mitigated through standard precautions and inclusion criteria. Expected benefits and impact : clarify the role of MAIT cells in HS pathophysiology; identify novel immune biomarkers predictive of biologic therapy response; support future therapeutic stratification and personalized treatment approaches in HS.

Participants needed: 45
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Hospices Civils de LyonUpdated: Feb 5, 2026Locations: 1
Eligibility criteria

Subject aged 18 to 65 years (included) [+12]

- Pregnancy or breast-feeding women [+11]