Minamiawaji

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

This research aims to evaluate the safety and effectiveness of belimumab in adults with interstitial lung disease (ILD) related to connective tissue diseases (CTDs) such as rheumatoid arthritis, lupus, and others. ILD causes lung inflammation and stiffness, reducing lung volume and leading to symptoms like shortness of breath, cough, and fatigue, significantly affecting quality of life and being a leading cause of death in these patients. The study focuses on whether adding belimumab to standard therapy can stabilize or improve lung function and relieve ILD symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both administered as a subcutaneous injection alongside their standard treatment. The study is a phase 3, double-blind, placebo-controlled trial designed to compare these two groups over time. Belimumab treatment is given under careful monitoring to assess its impact on lung disease progression. Throughout the study, participants will undergo assessments including lung function tests, specifically measuring forced vital capacity (FVC) at the start and after 52 weeks. Researchers will monitor changes in lung capacity to determine treatment effects. Participants will be evaluated for safety and symptom changes, with ongoing review of their ability to manage their condition. The total duration includes regular follow-ups and assessments to understand the long-term impact of the treatment.

Researchers are evaluating the safety and effectiveness of daily vosoritide injections compared to a placebo in infants and young children diagnosed with hypochondroplasia (HCH) aged from birth up to just under 36 months. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study focuses on participants with genetically confirmed HCH to better understand how vosoritide may impact their growth and health over a one-year period. Participants will be randomly assigned to receive either vosoritide or a placebo through daily subcutaneous injections for 52 weeks. The dosage of vosoritide will be adjusted based on the participant's weight following a specific weight-band regimen approved for a related condition, achondroplasia. After the treatment period, there will be a two-week safety follow-up to monitor any effects. Throughout the study, participants will undergo regular assessments including monitoring for treatment-emergent adverse events and serious side effects, changes in laboratory values like blood tests and urinalysis, and vital signs such as heart rate, respiratory rate, temperature, and blood pressure at multiple time points. Growth changes will also be measured by evaluating height Z-scores at the end of the 52-week treatment. These evaluations will help determine vosoritide’s safety and potential impact over the year-long study.

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 Glumetinib, a selective MET inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) who have specific MET alterations such as METex14 skipping mutations, MET amplification, or MET over-expression. The study includes patients with locally advanced or metastatic stages IIIb, IIIc, or IV NSCLC, including pulmonary sarcomatoid carcinoma, who have previously received treatments or are not eligible for chemotherapy. This trial is conducted in two phases: Phase Ib in China and Phase II globally, including a safety run-in in the US. Participants receive Glumetinib orally at a dose of 300 mg once daily while fasting. Phase Ib enrolls approximately 90 patients with various MET alterations. Phase II includes about 78 evaluable patients with METex14 skipping mutations who are either not eligible for or have declined chemotherapy or failed prior systemic therapies. A minimum of 6 patients will be included in the US safety run-in portion. Tumor tissue samples are collected for central laboratory testing to confirm MET status as part of the study procedures. Throughout the study, participants undergo assessments including tumor response evaluations based on RECIST 1.1 criteria, laboratory tests, and monitoring of safety and side effects. The primary outcome measured is the objective response rate over an average period of one year. Patients are monitored for treatment adherence and safety, with eligibility requiring adequate organ function and performance status. The total participant age range is 18 to 80 years, and both males and females can enroll.

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.

Researchers are evaluating the safety and effectiveness of peficitinib in patients with rheumatoid arthritis (RA) receiving treatment in routine clinical practice. This mandatory Post-Marketing Surveillance (PMS) study is conducted as part of the Japan Risk Management Plan (J-RMP) and requested by the Pharmaceuticals and Medical Devices Agency (PMDA). The aim is to collect real-world data on patients treated with peficitinib for RA. The study involves treatment with oral peficitinib, given as part of routine clinical care. There are no comparator groups; all participants will be patients receiving peficitinib for the first time. The study focuses on monitoring safety and effectiveness in an actual clinical setting without altering the standard treatment schedule. Participants will be followed for up to 156 weeks to assess safety outcomes such as the frequency of adverse events, serious infections, malignancies, and events leading to death. Effectiveness will be measured up to 52 weeks using disease activity scores including DAS28 (using C-reactive protein and erythrocyte sedimentation rate), Simplified Disease Activity Index, Clinical Disease Activity Index, tender and swollen joint counts, and global assessments by patients and physicians. Researchers will also evaluate EULAR response criteria and remission rates. This long-term follow-up provides comprehensive safety and effectiveness data in real-world RA treatment.

This survey investigates the safety of Ondexxya Intravenous Injection 200 mg in patients who received it to neutralize the anticoagulant effect of factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. The study aims to understand the occurrence of safety events known as "safety specifications," including thrombotic events, infusion reactions, and re-bleeding, as well as to detect any unknown adverse drug reactions and evaluate factors affecting safety and effectiveness under real-world use conditions. The survey collects safety and effectiveness information from all patients treated with Ondexxya for these bleeding emergencies. It does not involve comparison groups or additional interventions but focuses on monitoring the outcomes and adverse reactions associated with the drug's use in everyday clinical practice. Participants' data will be observed to measure the incidence of adverse drug reactions and safety events within 30 days after treatment. The study gathers information on patient background factors that might influence safety outcomes. There is no specified follow-up treatment or additional procedures; the total observation period for outcomes is 30 days post-treatment.