Miyazaki

Researchers are evaluating the safety and performance of the AMJ-401 Everolimus Eluting Resorbable Scaffold System in treating patients with ischemic heart disease in Japan. This study focuses on individuals undergoing percutaneous coronary intervention PCI for one or two new native coronary artery lesions. The investigation aims to assess how well AMJ-401 works in this setting and its safety profile. Participants will receive treatment with the AMJ-401 device during PCI of one or two new native coronary artery lesions located in separate epicardial coronary vessels. The study does not include a comparison group and involves the use of this device as the experimental intervention. The treatment is delivered during the PCI procedure, and the study evaluates outcomes related to the devices performance over time. During the study, participants will be monitored through clinical evaluations, including imaging and assessments of the treated arteries. The primary outcomes measured at six months include the occurrence of acute strut fractures and the coverage of the scaffold struts. Safety and performance will be observed throughout the follow-up period, which extends up to the study completion date in October 2031.

Researchers are comparing INCA033989 with the best available therapy for adults who have essential thrombocythemia ET with a CALR mutation and have previously received cytoreductive treatment. The study aims to evaluate the effects of these treatments on this specific patient group. It is a Phase 3 clinical trial sponsored by Incyte Corporation to assess treatment responses and safety. Participants will be randomly assigned to receive either INCA033989 administered intravenously or the best available therapy chosen by their doctor. The treatments are given according to the study protocol. The study focuses on treatment outcomes over a period of weeks, including response durability and symptom changes, with assessments at specified timepoints. During the study, participants will have regular visits to monitor their clinical and hematologic responses, symptoms, and any side effects. Researchers will collect data on mutation levels, symptom questionnaires, and fatigue assessments up to 48 weeks. Safety monitoring will continue for 60 days following the last dose. The total duration of participation may extend up to several months as outlined by the trial schedule.

Researchers are evaluating the tolerability of OJP-001, a combined therapeutic system that includes photodynamic therapy with OMD-001 and extracorporeal circulation therapies OJE-001 and OJC-001, in patients with adult T-cell leukemialymphoma ATL. The study also aims to find the recommended dose and study the way OMD-001 moves through the body, along with assessing the safety and effectiveness of OJP-001. This is a Phase III clinical trial sponsored by Otsuka Medical Devices Co., Ltd. Japan. In the Phase I part, patients receive a single oral dose of 5-ALA followed by one administration of OJP-001. The 5-ALA dose is increased across four groups from 10 mgkg up to 60 mgkg. In the Phase II part, patients receive both 5-ALA and OJP-001 once a week for six months. The treatment involves the use of a photodynamic system combined with 5-ALA, administered according to the defined dosing schedules. Participants will undergo safety and response evaluations during the first two weeks for Phase I and over 24 weeks for Phase II. The main outcomes measured include dose-limiting toxicities in Phase I and best overall response in Phase II. The study involves monitoring blood levels, physical status, and other health markers to assess treatment effects and safety. Total participation may extend up to six months during the Phase II treatment period.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the effects of nipocalimab on children aged 2 to less than 18 years with generalized myasthenia gravis gMG, a condition causing muscle weakness. The study aims to assess the safety, tolerability, and how the body processes nipocalimab in pediatric participants who have not responded well to stable standard treatments. This open-label, multicenter trial is sponsored by Janssen Research & Development, LLC and focuses on both pharmacokinetics and pharmacodynamics over an extended period. Participants are divided into two age groups children aged 2 to less than 12 years and adolescents aged 12 to less than 18 years, with US sites only including those 8 to less than 18 years old. All will receive nipocalimab through an intravenous infusion every two weeks for 24 weeks. After this treatment period, participants may choose to join a long-term extension phase to continue monitoring. Throughout the study, participants will undergo regular evaluations including blood tests to measure total serum immunoglobulin G IgG levels and monitor for adverse events, laboratory abnormalities, vital signs, and physical examinations. Additional assessments include measuring drug concentration and immune response markers. The study also tracks changes in myasthenia gravis symptoms and quality of life over a period of up to three years, with ongoing safety and pharmacokinetic monitoring during this time.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating oral Nuvisertib TP-3654, a PIM inhibitor, in a Phase 12 open-label trial for patients with intermediate or high-risk primary or secondary myelofibrosis. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Nuvisertib. Participants include those who have been previously treated with JAK inhibitors, those currently on ruxolitinib with suboptimal response, and patients treated with other JAK inhibitors except momelotinib. The trial includes three treatment arms Nuvisertib alone, Nuvisertib combined with ruxolitinib, and Nuvisertib combined with momelotinib. Patients will receive oral doses with dose escalation to determine safe and effective levels. Each arm enrolls specific patient groups based on prior treatments and response. The study monitors drug effects and interactions when used alone or in combination with other JAK inhibitors. Participants will be closely monitored for dose-limiting toxicities, adverse events, spleen volume reduction, symptom improvement, and other pharmacokinetic measures. Regular assessments include symptom scoring, imaging scans for spleen size, laboratory tests, and cardiac monitoring. The study duration and follow-up extend to evaluate both safety and preliminary activity, with careful tracking of treatment effects over time.

Researchers are evaluating the drug orforglipron in people who have obesity or are overweight and also suffer from osteoarthritis OA of the knee with pain. This study aims to assess how well and safely orforglipron works for this group of participants. The trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study sponsored by Eli Lilly and Company. Participation in the study will last about 74 weeks. Participants will be randomly assigned to receive orforglipron or a placebo orally. The study includes two independent groups under a master protocol, each comparing orforglipron to placebo. Treatment is given once daily, and the study design is parallel-arm, meaning participants remain in their assigned group throughout the trial. During the study, participants will undergo various assessments including pain evaluation using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, physical function tests, body weight measurement, health surveys, walking tests, and blood tests for inflammation markers and cholesterol. Safety and drug levels will also be monitored. These evaluations occur from the beginning of the study through week 72, with participant involvement spanning about 74 weeks total.