Ichinomiya

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are investigating the effects of two types of nerve blocksfemoral triangle block FTB and adductor canal block ACBon early quadriceps muscle function after total knee arthroplasty TKA. The study aims to find out if FTB leads to more early quadriceps weakness compared to ACB when both are used with a standardized multimodal pain relief plan. This randomized, double-blind trial involves adult patients undergoing primary unilateral TKA to better understand postoperative motor function and pain management.

Researchers are evaluating the safety and effectiveness of the Double-effect kissing balloon technique W-KBT using Perfusion balloon PB and Drug coated balloon DCB in patients with left main coronary artery disease LMD who have left circumflex artery LCx ostium stenosis. This prospective, observational, multi-center study focuses on patients with stable angina, non-ST-elevation myocardial infarction, or unstable angina who require percutaneous coronary intervention PCI. Patients who meet the selection criteria will receive PCI with W-KBT following crossover stenting for LMT-LAD direction, proximal optimization technique POT, and conventional kissing balloon technique C-KBT as part of usual care. Approximately 280 participants aged 18 and older will be enrolled across 17 sites in Japan. The study will monitor patients through hospital discharge and for 12 months afterward during routine clinical practice. Participants will be followed to assess procedure success during PCI and major adverse cardiovascular events MACE within 12 months. Additional measures include time to ST-change from DCB inflation, total DCB inflation time, changes in blood pressure and heart rate, use of vasopressors or mechanical support after W-KBT, and incidence of ischemia-driven revascularization at the LCx ostium. Data will be collected to evaluate the efficacy and safety of this treatment approach over the year following the procedure.