Suwa

Researchers are investigating the safety, tolerability, and effectiveness of two dosing regimens of itepekimab compared to placebo as an add-on to intranasal corticosteroids in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) that is not well controlled. This multinational Phase 3, randomized, double-blind, placebo-controlled trial involves male and female participants aged 18 years and older living with CRSwNP. Participants are randomly assigned to one of three groups receiving either itepekimab injections or placebo injections, both administered subcutaneously, alongside mometasone furoate nasal spray delivered intranasally. The study includes a 4-week screening period, followed by a 52-week treatment phase, and a 20-week safety follow-up, totaling up to 76 weeks. Participants transitioning to an extension study (LTS18420) will have a total duration of 56 weeks. Study visits include nine site visits and 20 phone or home visits. During the trial, participants will undergo assessments including endoscopic Nasal Polyp Scores (NPS) and Nasal Congestion Scores (NCS) measured from baseline to week 24 to evaluate changes. Researchers will monitor safety and tolerability throughout, with regular evaluations involving symptom severity, treatment adherence, and adverse events. The study aims to understand how well itepekimab works and is tolerated as an additional treatment for CRSwNP over the study duration.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

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.

Researchers are conducting a Phase 3, multicenter, placebo-controlled, randomized, double-blind study to evaluate treatments for patients with steroid-resistant pemphigus, a condition characterized by blistering of the skin and mucous membranes. The study focuses on patients who have shown resistance to steroid therapy and aims to assess the effectiveness of the investigational drug ONO-4059 compared to placebo. The main goal is to measure the proportion of patients achieving complete or partial response at 52 weeks and maintaining remission at 52 weeks from the initial remission. Participants will receive either ONO-4059, a Bruton's Tyrosine Kinase Inhibitor taken orally at a dose of 80 mg once daily after a meal, or a matching placebo administered with the same schedule. The treatment phase lasts for 52 weeks with close monitoring. The study is designed to compare the drug's impact against placebo in controlling pemphigus symptoms while tapering oral corticosteroids. During the trial, patients will be regularly assessed for disease activity using the pemphigus disease area index (PDAI) and monitored for response status, safety, and side effects. Researchers will track complete and partial responses as well as remission maintenance over the 52-week period. Safety evaluations include monitoring for infections, allergic reactions, and any malignancies. The total participation duration corresponds to the 52-week treatment and observation period.

This research aims to assess the long-term safety and tolerability of the drug cenobamate in Japanese patients who have partial onset seizures, a type of epilepsy. The study is a Phase 2, multicenter open-label extension trial focused on gathering safety data over an extended period to better understand how patients respond to this treatment. Participants receive cenobamate orally once daily throughout the study. There is no mention of comparator groups or additional treatments, as the focus is on monitoring the effects of cenobamate over time in this specific population. During the study, which lasts on average four years, researchers continuously monitor participants for adverse events and serious adverse events. Various tests are conducted regularly, including urinalysis for multiple parameters, liver function tests, hematology assessments, serum chemistry panels, heart rate, respiratory rate, blood pressure measurements, electrocardiograms (ECG), and evaluations using the Columbia-Suicide Severity Rating Scale (C-SSRS). These assessments help ensure participant safety and gather detailed health data throughout the study period.

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.

Researchers are evaluating the use of the Zephyr Endobronchial Valve in adult patients with severe emphysema causing lung hyperinflation. This multicenter, prospective, observational surveillance study will enroll 140 patients across 20 centers in Japan who are candidates for bronchoscopic lung volume reduction (BLVR) with little to no collateral ventilation confirmed by Chartis assessment. The study aims to understand safety and effectiveness over a 12-month follow-up period, including lung function, exercise capacity, symptoms, and quality of life. Participants will undergo a bronchoscopy with Chartis measurement to confirm collateral ventilation status before placement of the Zephyr Valve in the most damaged lung lobe. After valve placement, patients are hospitalized for at least three nights for observation. They will complete a pulmonary rehabilitation program between Day 45 and Month 3. Follow-up assessments include HRCT scans at Day 45 and Month 12, and lung function tests at Month 3, 6, and 12. During the 12 months, researchers will monitor participants for pneumothorax incidence at 45 days post-procedure as the primary safety outcome. Effectiveness will be assessed by measuring lung volume reduction, lung function (FEV1, residual volume), exercise capacity (6-minute walking distance), and symptom scores. Safety will be further evaluated by recording treatment-emergent adverse events throughout the study period.