Clinical Research Directory

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.

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).

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).

A Study to Evaluate the Efficacy of Botulinum Toxin in Patients With 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..

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.

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

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

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.

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.

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.

The Safety and Efficacy of Roflumilast Foam in HS

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

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)

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)

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100). The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa

This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.

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

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.

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.

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

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).

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.

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.

Real-World Study on the Burden of Hidradenitis Suppurativa

Despite the significant impact of HS on patients' quality of life (QoL) and daily functioning, there remains limited real-world evidence describing the burden of this condition in Canada. HS is an under-recognized and often misdiagnosed condition, with a substantial psychological and physical burden on patients. Understanding the real-world experiences of individuals living with HS in Canada can help identify unmet needs and inform patient-centered care approaches.

Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia

This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.

Comparison of the Clinical Efficacy and Safety of Topical and Subcutaneous Injection of Secukinumab in HS

Secukinumab is currently approved in Europe, US and China for the treatment of moderate to severe HS as a biologic agent targeting IL-17A.Two phase III clinical trials (SUNSHINE and SUNRISE) showed that 300 mg s.c. every 2 weeks resulted in 42% to 45% of patients achieving a clinical response (HiSCR) to HS, and the efficacy was sustained through 52 weeks.However, we found in clinical practice that some HS patients present with localized lesions (small areas of involvement, affecting only 1-2 anatomic areas) that are resistant to conventional therapy, and have not yet fulfilled surgical indications, and the need for systemic biologic therapy is controversial.Such patients often experience inadequate response or slow onset of action when they receive secukinumab by routine subcutaneous injection - possibly related to inadequate drug concentration in the focal lesional area and limited local anti-inflammatory effects after systemic administration.In addition, side effects of conventional subcutaneous injection system are greater, and the application is limited in some patients, so it is necessary to explore more appropriate and safer drug delivery method for localized skin lesions.Localized HS, local injection of lesions may enhance anti-inflammatory effects while reducing systemic exposure by increasing drug concentrations at the lesion site.Therefore, exploring novel modes of administration of secukinumab has practical clinical implications based on clinical practice needs and the context of the previous literature.In summary, by exploring the efficacy and safety of local skin injection of secukinumab, this study may provide a new strategy for the treatment of limited HS with sufficient scientific rationale and significant potential benefits and manageable risks.