Acne Inversa

Researchers are studying the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa (HS), a condition causing long-lasting painful red skin lumps. The study focuses on participants who have not responded well to antibiotics or could not tolerate them. This is a phase 2, randomized, double-blind, placebo-controlled trial to evaluate how well Ritlecitinib works compared to a placebo. Participants will be randomly assigned to receive either Ritlecitinib or a placebo pill that looks the same but contains no medicine. Those in the treatment group will take an oral loading dose once daily for 8 weeks, followed by a maintenance dose once daily for another 8 weeks. The placebo group will receive matching placebo pills on the same schedule. The total study duration is about 16 weeks. During the study, participants will attend about 10 clinic visits including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until week 16. At each visit, health status will be checked through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also use an electronic diary on their mobile phones to record daily medication intake and HS symptoms. The main measurement is the proportion of participants achieving a 50% reduction in HS symptoms by week 16. Safety and other symptom improvements will also be monitored.

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 drug's 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.

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 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.

Hidradenitis Suppurativa (HS) is a skin condition that causes painful bumps, abscesses, scars, and tunnels in areas where the skin rubs together. This condition may start when hair follicles become damaged, triggering the immune system and allowing bacteria to worsen the symptoms. Researchers are evaluating the safety, effectiveness, and tolerance of a drug called zasocitinib in adults with moderate to severe HS compared with a placebo in this Phase 2 clinical trial. Participants will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks in a double-blind period. After this, all participants will receive zasocitinib for an additional 36 weeks in an open-label period. The placebo capsules look like zasocitinib but contain no medicine. Treatment dosing involves a specific dose of zasocitinib labeled as Dose A. During the study, participants will visit the clinic 12 times for assessments. Researchers will monitor the percentage of participants achieving a 75% reduction in HS symptoms at week 16 as the primary outcome. They will also track safety through adverse events and other measures throughout the 56 weeks of treatment. Participants will undergo evaluations including clinical exams, questionnaires, and safety tests to understand treatment effects and tolerability.

Researchers are evaluating the safety and effectiveness of upadacitinib, an oral medication, in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded well or are intolerant to anti-tumor necrosis factor (TNF) therapy. HS is a painful inflammatory skin disease affecting areas such as the underarms, groin, and anal/genital regions. This phase 3 study is double-blinded, meaning neither participants nor doctors know who receives upadacitinib or placebo. The trial includes three periods and involves about 1328 participants worldwide. Participants will take oral tablets of upadacitinib or placebo once daily for 36 weeks during the first two periods. In Period 1, they are randomly assigned to receive either upadacitinib Dose A or placebo for 16 weeks. In Period 2, based on their response in Period 1, participants are divided into six groups receiving various combinations of upadacitinib doses or placebo for 20 weeks. Eligible participants continue to Period 3, a long-term extension, taking upadacitinib or placebo daily for 68 weeks, followed by a 30-day follow-up. During the study, participants will have regular outpatient visits for medical assessments, side effect monitoring, and questionnaires to track changes in disease activity and adverse events. The main outcomes include the percentage achieving clinical response (HiSCR 50) by week 16 and the number of adverse events up to week 108. Secondary outcomes measure changes in draining fistula count, symptom assessments, skin pain, odor, quality of life, and flare occurrence. This thorough monitoring helps evaluate treatment impact and safety over time.

Researchers are evaluating molecular changes in adults with moderate to severe hidradenitis suppurativa (HS) or moderate to severe atopic dermatitis (AD). This study includes two sub-studies, one for HS and one for AD, focusing on these chronic inflammatory skin diseases that cause painful skin lesions. The investigational drug lutikizumab (ABT-981) is being studied to understand its effects on these conditions. Participants with HS or AD will receive subcutaneous injections of lutikizumab during a treatment period lasting up to 15 weeks for HS and 14 weeks for AD, followed by a 70-day follow-up. HS participants who show benefit at week 16 may enter a long-term extension to continue treatment for up to 140 weeks with weekly doses, plus another 70-day follow-up. Different participant groups include those new to biologic treatments and those with prior inadequate responses to certain therapies. Throughout the study, participants will attend regular visits at hospital or clinic sites for medical assessments, blood tests, and biomarker collection. Researchers will monitor adverse events up to approximately 30 weeks. The total study duration for each sub-study may last up to 30 weeks, with some participants potentially continuing in the long-term extension phase. The study aims to carefully assess treatment impact and safety in this adult population.

Researchers are studying the concentration of bimekizumab, a medication used for conditions like moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, in mature breast milk from mothers receiving this treatment. This phase 1 study aims to understand how much of this drug is present in breast milk to inform safety and care decisions for breastfeeding mothers. The study involves breastfeeding mothers who are already receiving commercial bimekizumab as prescribed by their doctors. Participants will continue their treatment as usual while the research team collects breast milk samples on multiple days throughout the study, including days 1, 2, 3, 5, 7, 9, 11, 13, 15, 29, and 57, to measure bimekizumab levels. The study is open-label and prospective, meaning participants and researchers know the treatment being taken. During the study, participants will provide breast milk samples at specified times, and researchers will estimate the infant's dosage and relative intake of bimekizumab from breastfeeding. The study will also monitor any treatment-emergent adverse events for the mother from consent through about 17 weeks. Participation requires ongoing breastfeeding and continuing treatment, with careful monitoring throughout the sampling period and follow-up safety contact.