Ichikawa

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

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 the safety and effectiveness of KT-621, an oral drug, in adults and adolescents aged 12 to 75 years with moderate-to-severe atopic dermatitis (AD), a common form of eczema. This phase 2b study aims to assess how well KT-621 reduces the severity and extent of AD, its safety and tolerability, how the drug behaves in the body, and the body's response to the drug. The study includes a 16-week double-blind, placebo-controlled period followed by a 52-week open-label phase. Participants will receive either KT-621 or a matching oral placebo during the initial 16-week double-blind period. Following this, all participants have the option to enter a 52-week open-label period where they receive KT-621. During these phases, participants will continue their regular use of moisturizers twice daily and adhere to the treatment plan. The study is conducted across multiple centers and includes dose-ranging to evaluate different doses of KT-621. Throughout the study, participants will have scheduled visits for assessments including clinical evaluations of eczema severity using the Eczema Area and Severity Index (EASI) score, which measures changes from baseline through week 16. Other evaluations include questionnaires, laboratory tests, and adherence monitoring via an electronic diary. Safety and tolerability are closely monitored, and participants are expected to comply with all study procedures over the entire duration of the trial, including both the double-blind and open-label periods.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

Researchers are investigating the safety and effectiveness of KarXT in treating manic episodes in adults with Bipolar-I Disorder. This Phase 3 study focuses on individuals experiencing acute mania or mania with mixed features who require hospitalization. The study aims to compare KarXT with a placebo to see how well it reduces manic symptoms during a three-week inpatient period. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses during the inpatient treatment phase. The study is double-blind, so neither the participants nor the researchers know who receives which treatment. The total study duration, including screening, treatment, and safety follow-up, will not exceed seven weeks. During the study, participants will be closely monitored through psychiatric evaluations and rating scales, including the Young Mania Rating Scale (YMRS) to measure changes in mania symptoms by week 3. Other assessments include the Clinical Global Impressions-Bipolar scale and safety evaluations. Researchers will track adherence, symptoms, and any side effects throughout the study period.

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.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the safety and effectiveness of a 14-day intravenous infusion of teplizumab in Japanese participants aged 8 to 34 years who have Stage 2 Type 1 Diabetes. This Phase 2, two-arm study aims to assess teplizumab's ability to delay progression to Stage 3 Type 1 Diabetes. The study also examines the drug's pharmacokinetics, pharmacodynamics, and immunogenicity based on previous clinical data from Western countries. Participants will receive teplizumab through intravenous infusion following a dosing regimen consistent with the FDA-approved schedule for delaying Stage 3 Type 1 Diabetes onset. The study includes a treatment period of 14 days and lasts approximately 756 days in total to monitor long-term safety and effectiveness outcomes. Throughout the study, participants will undergo multiple assessments including monitoring for adverse events, vital signs, ECGs, and laboratory tests. Researchers will measure changes in C-peptide levels and endogenous insulin from baseline up to week 104 to evaluate beta-cell function. The total study duration involves continuous safety monitoring and collection of data to determine the number of participants progressing to Stage 3 Type 1 Diabetes.

Researchers are investigating treatments for bloodstream infections caused by the bacterium Staphylococcus aureus, which can be deadly within three months of infection. This international, multi-center Phase 4 adaptive platform trial evaluates multiple treatment options simultaneously to identify those that reduce death rates within 90 days of infection. The trial adapts over time by assigning more patients to better-performing treatments, removing less effective ones, and adding new options, aiming to find the best combination of therapies for patients with this serious infection. Participants receive various antibiotic treatments such as Cefazolin, Penicillin, Clindamycin, Vancomycin or Daptomycin, as well as strategies like early switching to oral antibiotics. The trial also includes whole body FDG PET/CT imaging using standardized protocols to support diagnosis and treatment decisions. Patients are randomly assigned to different concurrent treatment options currently used in routine care, with ongoing adjustments based on accumulating results. During the study, participants undergo regular evaluations including blood culture monitoring to confirm infection clearance, clinical assessments, and imaging when applicable. Researchers track all-cause mortality up to 90 days after enrollment as the primary outcome. The trial infrastructure supports additional sub-studies, with patient safety and treatment effectiveness closely monitored throughout the trial period.