Yamaguchi

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 the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

Crohn's disease is a chronic inflammatory condition affecting the digestive tract that currently has no cure. This research aims to evaluate the safety and effectiveness of upadacitinib in treating moderate to severe active Crohn's disease in a real-world setting in Japan. The study will monitor any adverse events and changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their doctors following local approved guidelines. Around 240 participants will be enrolled, and treatment will be according to each participant's usual clinical care. The study is observational and non-interventional, meaning no additional treatments or procedures beyond standard care will be required. Participants will be followed for up to 64 weeks, with study visits conducted either in person or virtually according to standard care practices. Researchers will assess safety by tracking serious infections related to the drug and monitor disease activity throughout the study period. There is expected to be no extra burden on participants beyond their routine care and assessments.

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 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.

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Researchers are evaluating the safety and effectiveness of a drug called JX10 compared to a placebo in adults who have suffered an Acute Ischemic Stroke (AIS) and arrive for treatment between 4.5 and 24 hours after symptom onset. The study aims to determine if JX10 improves functional recovery, measured by the modified Rankin Scale, and to assess the risk of symptomatic intracranial hemorrhage associated with the drug. The study has two parts: during Part 1, participants are randomly assigned to receive either JX10 at doses of 1 mg/kg or 3 mg/kg, or a placebo. In Part 2, participants receive the optimal JX10 dose identified in Part 1 or placebo. JX10 is a thrombolytic agent given to help dissolve blood clots causing the stroke. Participants will be monitored for outcomes including the proportion who have no or minimal symptoms 90 days after treatment and the occurrence of symptomatic bleeding within 36 hours after randomization. The study includes clinical assessments, imaging to confirm stroke and salvageable brain tissue, and safety monitoring to evaluate bleeding risks. The trial enrolls adults aged 18 to 90 years with specific stroke characteristics and follows them closely through treatment and recovery.

Researchers are evaluating the overall survival of women with stage I epithelial ovarian cancer following comprehensive staging surgery. This phase III trial compares the effects of adjuvant chemotherapy versus observation without chemotherapy in this patient group. Patients are randomly assigned based on histologic type, enrollment facility, and clinical staging according to the FIGO system. Participants are divided into two groups. Group A receives adjuvant chemotherapy, which includes either Paclitaxel plus Carboplatin or Docetaxel plus Carboplatin, administered every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. Group B undergoes observation only, with no chemotherapy given. The study treatment starts within eight weeks after comprehensive staging surgery. During the study, participants undergo regular assessments to monitor survival status up to 60 months from randomization. Researchers collect data including clinical evaluations, imaging, and laboratory tests as needed. Safety is closely monitored, and participants provide informed consent before enrollment. The trial aims to determine whether adjuvant chemotherapy improves survival compared to observation alone in this patient population.