Clinical Research Directory

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa

Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa

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.

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.

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.

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.

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.

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.

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.

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..

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).

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.

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.

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 \[NCT05620836\]).

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.

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 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.

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).