Urayasu

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2b study to evaluate the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). The study aims to find the best dose of GIA632 for further testing in a Phase 3 program. Participants must have a confirmed diagnosis of NSV with specific body surface area and Facial Vitiligo Area Scoring Index (F-VASI) scores. Participants will receive either GIA632 or a placebo during a 48-week core treatment period. This period is designed to establish the dose-response relationship and compare the effects of GIA632 with placebo. After this, there will be an extension phase to assess the longer-term safety and efficacy of the treatment. During the study, participants will be monitored for changes in their facial vitiligo through F-VASI scores from baseline to week 24. Researchers will also observe overall safety and treatment effects throughout the 48 weeks and the extension period. Participants will complete study-related questionnaires and follow study procedures to support the research assessments.

Researchers are evaluating the safety and effectiveness of rituximab (genetical recombination) given through an intravenous infusion for people with idiopathic membranous nephropathy who also have nephrotic syndrome. This phase 3 study aims to confirm how well rituximab works and how safe it is compared to a placebo. The study focuses on patients aged 15 years and older who meet specific clinical criteria related to their kidney condition and protein levels. Participants will receive either rituximab or a placebo through intravenous infusions given every two weeks for two doses during the double-blind phase. If patients do not show sufficient improvement by week 26, they may enter an open-label phase where they can receive rituximab again if deemed necessary by the investigator. The treatment dosing in the open-label phase is the same as in the initial phase, with two doses of 1,000 mg rituximab given every two weeks. During the study, participants will be monitored to measure the percentage of patients achieving predefined remission criteria by week 26. Assessments will likely include lab tests for protein levels and albumin in the blood, kidney function, and safety evaluations. The study involves informed consent, screening for eligibility, and ongoing monitoring to evaluate treatment response and safety throughout the study period.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Researchers are evaluating the safety and effectiveness of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin (CPUO), a condition causing severe itching without a known cause. This master protocol includes two parallel, double-blind, placebo-controlled Phase 3 studies (Study A and Study B) designed to assess dupilumab's impact on reducing itch severity. Both studies involve participants experiencing severe itch despite prior treatments and exclude those with pruritus caused by other known conditions. Participants first undergo up to a 4-week screening period, followed by a 4-week run-in phase where they receive a non-sedative antihistamine and an emollient. Those with severe itch at baseline are then randomly assigned to receive either subcutaneous dupilumab or a matching placebo for 24 weeks, alongside the antihistamine and emollient. After treatment, a 12-week follow-up phase monitors participants. Study durations for both studies can last up to 44 weeks per participant. During the study, participants are assessed for changes in itch severity using the worst-itch numerical rating scale (WI-NRS) and patient global impression of severity (PGIS). Researchers track the proportion of participants who achieve significant itch reduction by Week 24 in Study A and by Week 12 in Study B. Safety and efficacy are monitored throughout treatment and follow-up, with participant involvement including regular evaluations, questionnaires, and adherence to the assigned treatment regimen.

Researchers are evaluating the safety and effectiveness of surgical aortic valve replacement (SAVR) compared to transcatheter aortic valve replacement (TAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This prospective, randomized, controlled, multi-center study aims to determine if SAVR is not inferior to TAVR in terms of death from any cause, stroke, and rehospitalization related to valve procedures within one year after surgery. Participants will be randomly assigned to receive either SAVR or TAVR using commercially available surgical and transcatheter bioprosthetic valves. The study includes follow-up visits at hospital discharge, 30 days after the procedure, and then annually for up to 10 years to monitor outcomes and safety. Both procedures involve valve replacement but differ in their surgical approach. During the study, participants will undergo assessments to track mortality, stroke events, and hospital readmissions related to valve or procedure complications. Researchers will collect clinical data and monitor participants regularly over the long-term follow-up period to evaluate the combined primary endpoint at one year post-procedure and observe ongoing safety and effectiveness.

Researchers are evaluating the effectiveness and safety of a 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 is a prospective, observational, multi-center study focusing on patients with stable angina, non-ST-elevation acute coronary syndrome, or unstable angina who are undergoing percutaneous coronary intervention (PCI). Patients who meet selection criteria will be enrolled and treated under usual care. The PCI procedure involves W-KBT following crossover stenting for the left main trunk to left anterior descending artery direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) as the optimal treatment. Operators will obtain consent before performing PCI and will register cases continuously to assess the technique's efficacy and safety. Participants will undergo PCI with W-KBT, and data will be collected during the procedure to measure procedure success rates. Researchers will monitor major adverse cardiovascular events (MACE) within 12 months after PCI. The study will gather real-world data from multiple centers to evaluate the outcomes and safety of this treatment approach over time.

Researchers are investigating whether a combination of antiplatelet drugs works as well as intravenous tissue plasminogen activator (rt-PA) in treating small ischemic strokes known as lacunar strokes. This phase 4 trial aims to determine if the dual antiplatelet therapy is not inferior to the current standard rt-PA treatment and if it reduces bleeding complications compared to rt-PA. Participants will receive either a low-dose rt-PA treatment (0.6 mg/kg alteplase) or a dual antiplatelet therapy consisting of aspirin 200 mg and clopidogrel 300 mg. Treatment is given during the hyperacute phase of stroke, within 4.5 hours of symptom onset. The study compares these two approaches to assess their effectiveness and safety. During the study, participants will be monitored for neurological status three months after their stroke. Assessments may be conducted in person, by phone, or by mail. The main outcome measured is the proportion of participants achieving an excellent outcome three months post-stroke. Safety and treatment effects will be closely observed throughout the trial.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.