Sakaide

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.

This research aims to evaluate the long-term safety and effectiveness of lunsekimig in adults with asthma who have previously completed related parent studies. It is a phase 2, open-label extension study offering eligible participants continued treatment to assess ongoing outcomes. The study focuses on adults who have stable asthma managed with moderate or high-dose inhaled corticosteroids and other controller medications. Participants will receive lunsekimig as a subcutaneous injection in solution form. The study duration extends up to 100 weeks, with treatment lasting up to 96 weeks. This extension study follows participants from previous trials, allowing them to continue lunsekimig treatment while being closely monitored. During the study, participants will undergo regular visits and procedures to track safety and efficacy. Researchers will monitor the number of participants experiencing any treatment-emergent adverse events, including serious or special interest events, from the start to week 100. Participants must comply with contraception requirements and attend scheduled assessments 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.