Konan

Researchers are conducting a phase 3, open-label extension study to assess the long-term safety and tolerability of KarXT for treating mania or mania with mixed features in adults with Bipolar-I disorder. The study focuses on evaluating how participants respond to KarXT over an extended period, emphasizing safety measurements such as adverse events and symptom changes. Participants will receive KarXT at specified doses over a treatment period lasting up to 54 weeks. This study includes participants previously involved in related placebo-controlled studies as well as new participants diagnosed with Bipolar-I disorder with manic symptoms. The treatment may be given alongside standard therapeutic doses of lithium, valproate, or lamotrigine as applicable. Throughout the study, participants will undergo regular assessments including monitoring of treatment emergent adverse events, serious adverse events, and psychiatric symptom scales like the Columbia-Suicide Severity Rating Scale, Young Mania Rating Scale, and others. Safety and tolerability will be closely tracked, with evaluations occurring up to week 54. The entire participation may last until the study end date in June 2028, ensuring comprehensive long-term follow-up.

Researchers are evaluating KarXT for the treatment of manic episodes in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind, placebo-controlled study involves participants experiencing an acute episode of mania or mania with mixed features. The study aims to compare the effectiveness and safety of KarXT against a placebo during a 3-week inpatient treatment period. Participants will receive flexible dosing of either KarXT or placebo during the 3-week double-blind inpatient phase. Before treatment, psychotropic medications must be washed out within 14 days. The study includes screening, the treatment period, and a safety follow-up, totaling no more than seven weeks. During the study, participants will have their symptoms assessed using tools such as the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Researchers will monitor changes in mania symptoms and overall clinical impression at week 3. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the efficacy and safety of KarXT in adult Japanese participants who are acutely psychotic with schizophrenia. This Phase 3 study focuses on adults aged 18 to 65 years who meet specific criteria based on psychiatric evaluations and symptom severity scores. The trial aims to understand how KarXT affects schizophrenia symptoms compared to a placebo over a 5-week period, followed by a longer open-label extension. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind treatment phase. Following this, they may enter a 52-week open-label extension where all participants receive KarXT. The study includes regular dosing on specified days, with careful monitoring throughout both phases. During their participation, individuals undergo assessments of symptom changes using scales like the Positive and Negative Syndrome Scale PANSS and Clinical Global Impressions-Severity CGI-S. Safety is closely monitored through reports of adverse events, physical exams, laboratory tests, heart rate and blood pressure measurements, and other evaluations. The total study duration can last over a year, allowing for detailed observation of treatment effects and safety over time.

Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.