Miyazaki

Researchers are evaluating the safety and performance of the AMJ-401 Everolimus Eluting Resorbable Scaffold System for treating patients with ischemic heart disease who have one or two new coronary artery lesions. This clinical investigation focuses on patients undergoing percutaneous coronary intervention (PCI) in separate epicardial coronary vessels. The study aims to gather evidence on this device's use in native coronary artery lesions. Patients will receive the AMJ-401 device during PCI to treat their coronary artery blockages. This device is designed to be a resorbable scaffold that elutes everolimus. The study includes patients who require treatment for one or two de novo lesions in separate vessels. There is no mention of comparator groups or additional interventions. The trial is conducted in Japan and assesses outcomes at 6 months. Participants will be monitored for outcomes including acute strut fracture and strut coverage at 6 months after the procedure. The study involves follow-up evaluations and assessments to measure these outcomes. Participants must consent to the study and meet eligibility criteria before enrollment. The study monitors safety and device performance during and after the intervention.

Researchers are investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

Researchers are evaluating the tolerability and safety of OJP-001, a combined therapeutic system using photodynamic therapy (PDT) with OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study aims to determine the recommended dose and pharmacokinetics of OMD-001, as well as assess the efficacy and safety of OJP-001 in this patient population. This is a Phase I/II trial focusing on patients with recurrent or relapsed ATL with peripheral blood tumor involvement. In the Phase I part, patients receive a single oral dose of 5-ALA at increasing doses (10, 20, 40, or 60 mg/kg) followed by one administration of the photodynamic system (OJP-001). In the Phase II part, patients are treated with 5-ALA and the photodynamic system once weekly for six months. This study evaluates different dosing levels during Phase I and then continues with weekly treatments in Phase II to monitor longer-term effects. Participants will undergo assessments including response evaluation over 24 weeks in Phase II and monitoring for dose-limiting toxicities over 2 weeks in Phase I. Researchers will monitor safety, pharmacokinetics, and treatment response. The study includes laboratory tests, clinical evaluations, and safety observations throughout the treatment periods to evaluate the best overall response and tolerability of the therapy in patients with ATL.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the effects of nipocalimab on children and adolescents aged 2 to less than 18 years with generalized myasthenia gravis (gMG), a condition causing muscle weakness. The study aims to understand how nipocalimab impacts total serum immunoglobulin G (IgG) levels, its safety, tolerability, and how the drug behaves in the body (pharmacokinetics) in participants who have not responded well enough to their current standard treatments. This research includes participants globally aged 2 to under 18 years, with a focus in the United States on ages 8 to under 18 years. Nipocalimab will be given as an intravenous (IV) infusion to participants. The study is open-label and uncontrolled, meaning all participants receive the drug and know they are receiving it. The study will monitor participants for up to three years to assess the drug’s pharmacokinetics, pharmacodynamics, safety, and activity. During this time, researchers will carefully observe changes in IgG levels, measure the concentration of nipocalimab in the blood over time, and track any adverse events or safety concerns. Participants will be closely followed with blood tests to measure IgG levels and drug concentrations, physical examinations, vital sign checks, and laboratory tests over the three-year period. Researchers will record any infectious or serious adverse events and monitor for any abnormalities in laboratory tests or physical exams. The study’s long duration allows a thorough evaluation of how the drug works and its safety profile in children and adolescents living with generalized myasthenia gravis.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral Nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary myelofibrosis. This Phase 1/2 open-label, multicenter, dose-escalation trial includes patients who have previously been treated with JAK inhibitors or are ineligible for them. The study aims to assess how the drug behaves in the body and its safety profile in this patient group. The study consists of three arms: one enrolling patients treated with JAK inhibitors who are intolerant or resistant; a second arm including patients on a stable dose of ruxolitinib but with suboptimal or lost response; and a third arm with patients previously treated with a JAK inhibitor other than momelotinib. Participants receive oral Nuvisertib alone or in combination with ruxolitinib or momelotinib. Treatment dosing and schedules follow a dose-escalation and expansion design specific to each arm. Participants undergo assessments to monitor dose-limiting toxicities within 28 days and treatment-emergent adverse events throughout the study. Researchers also evaluate preliminary activity by measuring spleen volume reduction. Regular laboratory tests, imaging scans, and symptom questionnaires are used to track safety and effectiveness. The total study duration includes screening, treatment, and follow-up periods to ensure comprehensive monitoring of patient outcomes.

Researchers are evaluating the safety and effectiveness of orforglipron, taken once daily, in people who are overweight or have obesity and also suffer from knee osteoarthritis with pain. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how well orforglipron works over about 74 weeks. The study is part of a larger master protocol supporting two independent studies focused on this condition and population. Participants will receive either orforglipron or a placebo, both administered orally. The study compares these two groups in a parallel-arm design to assess treatment effects. The trial includes a long treatment and observation period lasting about 74 weeks to monitor changes and safety outcomes. Throughout the study, participants will be assessed for changes in their knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, measured at the start and at week 72. Researchers will also monitor the participants' safety and overall health during the trial. The participation duration is approximately 74 weeks, including screening, treatment, and follow-up visits.