Neyagawa

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 trial investigates the efficacy and safety of SEP-363856 (Ulotaront) in adults aged 18 to 65 experiencing acute psychotic episodes related to schizophrenia. It is a Phase 3, randomized, double-blind, placebo-controlled, and multicenter study designed to evaluate treatment effects in participants undergoing symptom relapse or exacerbation within two months before screening. The study focuses on individuals requiring hospitalization for these symptoms and assesses changes in psychosis severity. Participants are randomly assigned to receive either SEP-363856 tablets or placebo tablets during the treatment period. The study design includes parallel groups to compare outcomes between the investigational drug and placebo. Treatment duration and dosing details are consistent with the study protocol but are not specified in this summary. Throughout the study, researchers monitor participants using the Positive And Negative Syndrome Scale (PANSS) to measure changes in symptom severity from baseline to Week 6. Additional assessments include Clinical Global Impression-Severity (CGI-S) scores and safety evaluations. The total study period includes screening, treatment, and follow-up to ensure comprehensive monitoring of efficacy and safety in acutely psychotic individuals with schizophrenia.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.