Matsumoto

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This Phase 3, open-label study aims to monitor the safety of this treatment over an extended period in a pediatric population. Participants will receive guselkumab through subcutaneous injections. The study includes those who have completed the initial pediatric guselkumab dosing and have benefited from continued therapy as judged by their doctor. The study focuses on long-term treatment, with safety assessed by tracking adverse events for up to 6 years and 9 months. During the study, children will be regularly monitored for treatment-emergent adverse events. Parents or guardians will provide consent, and children able to understand will give assent. Researchers will collect data to assess safety throughout the treatment period, ensuring careful observation of participants' health and responses to guselkumab.

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Researchers are evaluating the safety and effectiveness of talquetamab, a humanized bispecific antibody, in adults with relapsed or refractory multiple myeloma. This study focuses on participants who have measurable disease and seeks to determine the recommended Phase 2 dose(s) of talquetamab. It is an open-label, dose escalation trial designed to treat hematological malignancies, specifically multiple myeloma. Participants will receive talquetamab administered subcutaneously (under the skin) and continue treatment until their disease progresses. The study includes multiple cohorts based on disease measurability assessed by either central or local laboratory testing. The investigational drug is given repeatedly under careful monitoring as part of this Phase 2 study. Throughout the study, participants will undergo regular assessments to monitor response to treatment, with the primary outcome being the overall response rate measured for up to nearly three years. Other evaluations include performance status checks, pregnancy testing for women of childbearing potential, and close observation for any side effects. Safety and treatment effectiveness will be followed until disease progression or other study endpoints.

Researchers are evaluating TRK-950, a biological treatment, in an open-label Phase I/II study involving patients with advanced solid tumors and unresectable or metastatic melanoma. The study is divided into three parts: Part 1 focuses on safety and tolerability of TRK-950 alone in patients with advanced solid tumors resistant or intolerant to standard therapies. Part 2 assesses safety and tolerability of TRK-950 combined with nivolumab in patients eligible for nivolumab therapy. Part 3 evaluates the efficacy of TRK-950 in patients with advanced unresectable melanoma who previously received chemotherapy with dacarbazine and have no standard therapy options. In Part 1, participants receive TRK-950 at two dose levels (5 or 10 mg/kg) administered intravenously over 60 minutes weekly. In Part 2, patients receive TRK-950 at two dose levels combined with nivolumab 240 mg intravenously over 30 minutes every two weeks. Part 3 participants receive TRK-950 at 10 mg/kg intravenously over 60 minutes weekly. The study monitors pharmacokinetics and immune responses against TRK-950 across these treatment regimens. Participants will be closely monitored for safety, including dose-limiting toxicities during the first 28 days and adverse events throughout approximately one year. The study measures objective response rate in Part 3 up to 12 months. Patient evaluations include assessments of side effects, immune reactions, and how well the treatments are tolerated. Overall participation duration varies by study part, with follow-up extending through study completion for safety evaluation.

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.

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Researchers are conducting a Phase 3, randomized, double-blind, multiregional study to compare two treatments for metastatic non-small cell lung cancer (NSCLC). The study includes two separate groups based on NSCLC histology: squamous and non-squamous types. The main goals are to evaluate overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab combined with platinum-doublet chemotherapy or pembrolizumab combined with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. Each histology group will be analyzed separately, with about 600 patients in the squamous group and 1000 in the non-squamous group. During the study, participants will be monitored for survival outcomes over approximately 3 to 4 years. Researchers will assess tumor response and safety through regular evaluations. Eligibility requires confirmed metastatic NSCLC, with specific tumor measurements and no prior systemic treatment for metastatic disease. This study aims to provide important information on these first-line treatment options for metastatic NSCLC.

Researchers are evaluating the effects of the drug tofogliflozin compared to metformin on kidney health in adults with type 2 diabetes who also have chronic kidney disease. This Phase 2, multicenter, randomized, open-label study focuses on changes in the urine albumin-to-creatinine ratio (UACR), a marker of kidney function, over 52 weeks of treatment. The study aims to understand how these treatments impact kidney function and other health markers in this patient group. Participants will be randomly assigned to receive either tofogliflozin or metformin. Tofogliflozin is given as a 20 mg tablet once daily, taken before or after breakfast, for up to 104 weeks. Metformin treatment starts at 500 mg daily, divided into 2 to 3 doses taken before or after meals, with a usual maintenance dose between 750 and 1,500 mg daily and a maximum dose of 2,250 mg daily, also for up to 104 weeks. Randomization considers factors like baseline UACR, kidney function (eGFR), and age. During the study, participants will undergo regular assessments including urine and blood tests to monitor UACR, kidney function, blood sugar control (HbA1c), body weight, blood pressure, cholesterol, and other related health indicators. Researchers will track the changes from baseline over the 52-week treatment period and continue monitoring safety and effectiveness during the full 104 weeks. The study requires patients to be 20 years or older and to have certain kidney function and diabetes control levels before joining.

Researchers are evaluating the effectiveness and safety of different drug treatments in Japanese patients with osteoporosis who have completed 2 years of denosumab therapy. This Phase 2 study compares three groups: those receiving selective estrogen receptor modulators (SERM) plus eldecalcitol (ELD), those receiving bisphosphonates plus ELD, and those receiving ELD alone, all over a 24-month period. The goal is to assess how these treatments impact bone mineral density and observe any adverse effects. Participants will be assigned to one of three treatment groups. One group will take SERM "ViviantTablet 20mg" combined with ELD "EdirolTablet 0.75ug" daily. Another group will receive bisphosphonates plus the same dose of ELD. The third group will take only ELD at the same dosage. Treatments will continue for 24 months following the initial denosumab therapy. During the study, participants' bone mineral density will be measured at the start and after 2 years to evaluate changes. Researchers will monitor safety and any adverse events throughout the treatment period. The total participation time for each patient is 2 years under these post-denosumab therapies to better understand long-term effects and bone health outcomes.

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.