Acne Inversa

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 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.

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.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

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.

This research focuses on breastfeeding mothers who are receiving bimekizumab, a treatment for conditions such as moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. The study aims to measure the amount of bimekizumab present in mature human breast milk. It is a phase 1, open-label study sponsored by UCB Biopharma SRL, designed to understand drug exposure through breastfeeding. Participants are women who continue to receive commercially available bimekizumab as prescribed by their physicians. They will be monitored while breastfeeding, with breast milk samples collected on multiple days spanning from Day 1 to Day 57. The study does not alter their treatment but observes the concentration of bimekizumab in breast milk during this sampling period. Throughout the study, researchers will collect breast milk samples on specified days to assess bimekizumab levels and estimate infant exposure. Safety will be monitored by recording any treatment-emergent adverse events in the mothers from the time of consent through follow-up. The total duration of active sampling and monitoring extends to approximately 17 weeks, during which mothers will be observed under the care of their treating physicians.