Hidradenitis Suppurativa

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Takayasu arteritis TAK is a rare chronic inflammatory disease affecting arteries, and there is no widely accepted effective treatment strategy. Researchers classify TAK patients into three severity levels mild, moderate, and severe. This study focuses on severe TAK patients and compares two biological agents, tocilizumab and adalimumab, to find which treatment may provide better intervention outcomes in this group. The study randomly assigns severe TAK patients to receive either tocilizumab at a dose of 8mgkg intravenously every four weeks or adalimumab at 40mg biweekly by injection for 24 weeks. Patients start with prednisone at 40mg daily, tapered gradually over months, and treatment adjustments are made if disease relapse occurs. After 24 weeks, if remission is not achieved, patients switch to the other biological agent for an additional 24 weeks. Participants are monitored throughout treatment and follow-up for disease remission using clinical and laboratory assessments. Researchers track disease relapse, vascular progression through angiographic exams, prednisone dose reduction, and quality of life changes using questionnaires over a total of 48 weeks. The primary outcome is disease remission at 24 weeks. Safety and disease activity are closely observed during the study.

Researchers are evaluating and comparing the effectiveness and safety of two treatments, secukinumab and tofacitinib, in adults with moderate to severe hidradenitis suppurativa HS. The study aims to find out which treatment works better for this condition and to understand the medical problems participants may experience with each drug. Participants will be adults aged 18 to 75 years with moderate to severe HS, specifically Hurley stage II or III, who have had an inadequate response or intolerance to previous antibiotic treatments. Participants will be randomly assigned to one of two groups. One group will receive secukinumab 300 mg by injection every week for the first month and then every four weeks for up to one year. The other group will take a daily 11 mg tablet of tofacitinib for one year. During the study, participants will visit the clinic every two weeks for the first month and then every four weeks for checkups and tests. Throughout the trial, participants will keep a diary to track their symptoms. Researchers will assess clinical response using the Hidradenitis Suppurativa Clinical Response HiSCR at 12 weeks and again at one year. They will also monitor the frequency and severity of any adverse events during the study. Safety and effectiveness will be evaluated over the full one-year treatment period, with regular laboratory tests and follow-up visits to ensure participant well-being.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating LT-002-158, an oral IRAK4 protein degrader being developed to treat autoimmune diseases and inflammation, including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human Phase 1 study aims to assess the safety, tolerability, and how the drug is absorbed and processed in the body pharmacokinetics and pharmacodynamics in healthy adult volunteers. The study also examines how food intake affects the drugs absorption. The trial includes three parts Part 1 involves single ascending doses where groups of healthy volunteers receive either LT-002-158 or placebo, starting at 50 mg, with doses increasing if tolerated. Part 2 is a crossover study with healthy volunteers receiving a single dose of LT-002-158 under different food conditions fasted, standard meal, and high-fat meal to evaluate food effects. Part 3 involves multiple ascending doses given daily for 14 days, with dosing levels determined based on earlier safety and pharmacokinetic data. Participants will be closely monitored through physical exams, vital signs, ECGs, laboratory tests, and pregnancy tests for women. Researchers will track safety and how the drug behaves in the body up to 28 days after dosing. Volunteers must comply with scheduled visits and procedures throughout the study, which is expected to run until June 2025.

This research aims to evaluate the accuracy of the Belle.ai software in diagnosing common dermatologic diseases across different skin tones. The software uses deep learning technology to analyze clinical images of skin conditions and provides a differential diagnosis from a database of over 2,000 skin conditions based on more than 500,000 images. The study will determine how well the AI-generated diagnoses match those of dermatology experts. Participants who consent will have three images taken of their skin condition using the Belle.ai software. These images will be de-identified and uploaded into the system, where the software will generate a single list of possible diagnoses. Dermatology experts will then review the cases to compare their diagnoses with the AI results. The study will be conducted at dermatology clinics within the Advocate Health system. During the study, images will be captured and uploaded securely without any personal identifiers. The Dermatologic Review Committee will assess the concordance between the AIs primary diagnosis and expert opinions, aiming for greater than 80% agreement. Participants will not need to complete any additional forms, and their involvement primarily involves image capture during their clinic visit. The main outcome measured is the agreement between AI and physician diagnoses on the day of image capture.

Researchers are evaluating topical roflumilast 0.3% foam as a treatment for patients with Hidradenitis Suppurativa HS, a skin condition involving inflammatory lesions. This phase 2a, open-label study explores its safety and effectiveness both as a stand-alone treatment for mild HS and as an add-on therapy for moderate to severe cases. The study includes gene expression analysis to understand changes before and after treatment. Participants will apply topical roflumilast foam once daily to affected areas. Those with mild HS Hurley stage I will use it as monotherapy, while patients with moderate to severe HS Hurley stage II or III will add it to their stable existing treatments. The treatment period lasts 4 months, with gene expression profiling performed to assess molecular changes resulting from therapy. Participants will undergo evaluations including gene expression testing via tape strip collections at baseline and week 16. Other assessments will measure treatment response, quality of life, and pain levels at baseline, 1 month, and 4 months. Safety and tolerability will be monitored throughout the study, which runs from screening through 4 months of treatment to understand how the foam affects HS symptoms and patient well-being.

Researchers are evaluating the effectiveness and safety of baricitinib for treating severe or very severe alopecia areata, a form of hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to better understand how baricitinib works in this young population with this condition. The study is sponsored by Eli Lilly and Company and focuses on pediatric patients with a history of severe alopecia areata. Participants are randomly assigned to receive either a high dose or low dose of baricitinib taken orally, or a placebo. The study is divided into four periods a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive the assigned study medication, an approximately 2-year long-term extension period for ongoing treatment, and a 4-week post-treatment follow-up. Some participants may continue treatment for up to a total of 180 weeks if eligible after the extension period. Throughout the study, participants undergo regular assessments including measurement of hair loss severity using the Severity of Alopecia Tool SALT score, patient-reported outcomes related to scalp hair and eyebroweyelash hair loss, and quality of life questionnaires. Safety and pharmacokinetics of baricitinib are also monitored. The primary outcome is to measure the percentage of participants achieving a SALT score of 20 or less by week 36. Participants receive careful monitoring during and after treatment, with the total study duration extending over multiple years.

Researchers are evaluating the effects of different dosing schedules of LAD191 in adults with moderate-to-severe Hidradenitis Suppurativa HS. This phase 2 study aims to compare LAD191 with a placebo and adalimumab, focusing on how well the treatments work, their safety, tolerability, how the body processes the drug, and immune system responses. The study uses an adaptive design with interim data to assess whether to continue certain doses. Participants will undergo up to 4 weeks of screening before entering a 16-week double-blind, placebo-controlled treatment period Treatment Period 1. Then, all participants will receive LAD191 in a 16-week double-blind period Treatment Period 2. The study includes five groups three doses of LAD191, placebo during the first period then LAD191, or adalimumab during the first period then LAD191. After these treatment periods, there is a 12-week safety follow-up. During the study, participants will receive subcutaneous injections as per their assigned group. Researchers will assess the proportion of participants achieving significant reductions in HS lesions at week 16 using clinical response scores. Additional measures include skin pain levels and quality of life related to HS. Safety, tolerability, and other health evaluations will occur throughout the trial. Total participation spans screening, two treatment periods, and safety monitoring until study completion.