Okinawa

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating the effectiveness and safety of KarXT in Japanese adults aged 18 to 65 who are experiencing acute psychotic episodes due to schizophrenia. The study focuses on adults diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) and confirmed by a psychiatric interview. Participants must have a specific range of symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scale. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind phase where neither the participants nor the researchers know which treatment is given. After this, there is a 52-week open-label extension where all participants receive KarXT. The doses are specified and administered on set days throughout the study. Throughout the study, researchers monitor changes in schizophrenia symptoms using the PANSS score at week 5 and track any treatment-emergent adverse events up to week 52 during the open-label extension. The study involves regular assessments to ensure safety and effectiveness over both the short and long term, with total participation lasting up to 57 weeks.

Researchers are evaluating the effectiveness, safety, and behavior of a new treatment called sefaxersen (RO7434656), an Antisense Oligonucleotide (ASO) therapy, for people with primary IgA nephropathy (IgAN). The study focuses on participants who have a high risk of their kidney disease worsening despite receiving the best available supportive care. This is a Phase III, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants will receive either sefaxersen or a matching placebo through subcutaneous injections according to a specified schedule. The study compares these two groups to see how the treatment affects kidney function over time. The intervention is designed to inhibit Complement Factor B, which is involved in the disease process. The study includes vaccination requirements and contraceptive use for women of childbearing potential to ensure safety. During the study, participants will be monitored for changes in their urine protein-to-creatinine ratio (UPCR) at baseline and at week 37, which is the primary measure of kidney function improvement. Other assessments include kidney biopsy results, kidney function tests estimating glomerular filtration rate (eGFR), and ongoing safety evaluations. The trial tracks participants' health closely to assess the treatment's effect and any side effects throughout the study period.

This research aims to evaluate the safety and explore the effectiveness of JR-446, a drug being developed to treat patients with Mucopolysaccharidosis Type IIIB (MPS IIIB), a rare genetic condition. The study is an open-label Phase I/II trial that includes children under 18 years old with a confirmed diagnosis of MPS IIIB. Participants will receive JR-446 through intravenous infusion. The study focuses on monitoring how well patients tolerate the drug and its effects over time, with multiple visits planned for up to four years. This long-term approach helps understand the drug's safety and how it impacts the disease. During the study, participants will have regular assessments to track safety and pharmacodynamic effects, such as laboratory tests and clinical evaluations. Researchers will carefully monitor for any side effects or adverse reactions and measure how the drug works in the body. The total duration of participation may extend up to four years, involving multiple visits for thorough observation and follow-up.

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 clinical effects of Awiqli (Insulin Icodec) in people with diabetes mellitus in Japan during routine clinical care. This study aims to understand how Awiqli works and how safe it is when used in real-world medical settings. Both men and women of any age with a diabetes diagnosis can participate, and the study will last about one year. Participants will receive Awiqli as prescribed by their treating doctor according to usual medical practice. The treatment involves using commercially available Awiqli once weekly. This is a single-group, open-label, non-interventional study, meaning there is no placebo or comparison group and the treatment is given as part of normal care. Throughout the 52-week study, researchers will collect data on any adverse reactions from the start until the end of the study. Participants will be monitored for safety and clinical outcomes as they use Awiqli. The study includes regular follow-up to assess treatment effects and collect safety information over the full year.