Komatsu

This research aims to evaluate the effectiveness and safety of an oral drug called ozanimod (RPC1063) in treating children and teenagers aged 2 to 17 years who have moderate to severe active ulcerative colitis (UC). These young participants have not responded well to standard treatments, and the study focuses on helping them achieve and maintain clinical remission of their condition. Participants will receive specified doses of ozanimod by mouth according to a set schedule. The study is a Phase 2/3, randomized, double-blind trial conducted at multiple centers. The goal is to assess how well ozanimod works and how safe it is in this pediatric population with UC that extends beyond the rectum. During the study, researchers will monitor participants closely through medical assessments, including endoscopy to confirm disease extent and other evaluations to track disease remission. The main outcome measured is the proportion of participants who reach clinical remission by Week 52. Safety and drug behavior in the body will also be observed throughout the trial period.

This research aims to assess the safety and effectiveness of Fabhalta capsules in patients diagnosed with C3 glomerulopathy, including those who have experienced recurrence after a kidney transplant. The study focuses on real-world clinical practice to better understand how Fabhalta performs in managing this condition. The study involves patients who have already been treated with Fabhalta for C3 glomerulopathy. There are no additional interventions or comparator groups described, as the study is observational and monitors the outcomes of those using Fabhalta. Participants will be followed for up to 360 days, during which researchers will track the number of patients who develop infections. This monitoring helps evaluate the safety profile of Fabhalta over time. No other specific assessments or procedures are detailed in the study information provided.