Obihiro

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the safety and effectiveness of ONO-2020 in adults aged 55 to 90 years with agitation linked to Alzheimers Disease dementia. This phase 2a, randomized, placebo-controlled study is conducted across multiple centers in Japan and aims to better understand how ONO-2020 affects agitation symptoms in this population. Participants will be randomly assigned to receive either two ONO-2020 tablets or two placebo tablets once daily. The treatment period lasts up to 12 weeks, during which patients are hospitalized from 21 days before treatment starts through the treatment phase. The study is designed as a double-blind, parallel-group trial to compare ONO-2020 against placebo. Throughout the study, researchers will monitor changes in agitation using the Cohen-Mansfield Agitation Inventory CMAI and assess safety through vital signs, ECG measurements, laboratory tests, and the Columbia-Suicide Severity Rating Scale. Additional assessments include cognitive function tests and daily living activity scores. The study will continue safety monitoring up to 16 weeks, with the primary evaluation of agitation changes by week 12.

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 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 effectiveness and safety of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin CPUO, a condition causing severe itch without a known cause. This Phase 3 study involves two parallel double-blind trials, Study A and Study B, designed to assess dupilumabs impact on severe itch compared to placebo while participants also use non-sedative antihistamines and moisturizers. The study includes a screening period, a run-in period, and treatment followed by a follow-up. Participants will first undergo up to 4 weeks of screening, then a 4-week run-in period during which they receive non-sedative antihistamines and emollients. Those with severe itch scores will be randomly assigned to receive either dupilumab or placebo injections every two weeks for 24 weeks, alongside their antihistamine and moisturizer regimen. After treatment, participants will be followed up for 12 weeks to monitor ongoing effects and safety. During the study, participants will have regular assessments of their itch severity using a worst-itch numerical rating scale, quality of life questionnaires, and mental health evaluations. Researchers will monitor adverse events and immune responses to the drug. The total participation lasts up to 44 weeks, including screening, treatment, and follow-up, to evaluate changes in itch severity, sleep disturbance, and overall well-being.

Pancreatic cancer is often diagnosed at an advanced stage, and there is no established effective population-based screening method. This study evaluates the Enzeavour Pancreatic Cancer assay, a blood test that measures three specific enzymes at a single-molecule level and combines four biomarkers into a composite Enzeavour Score. The trial is a nationwide, multicenter, prospective, single-arm feasibility study conducted in Japan, enrolling about 10,000 asymptomatic adults. Participants undergo the Enzeavour assay during routine health checkups or organized cancer screening visits. Those with an Enzeavour Score above 0.369 are referred for further diagnostic imaging, which may include MRCP, EUS, or contrast-enhanced CT based on clinical indications. This study uses a partial verification design with 12-month follow-up for specific subgroups to estimate pancreatic cancer detection rates and positive predictive value. Throughout the study, participants provide peripheral blood samples for the assay and may undergo diagnostic imaging if their test is positive. Researchers monitor pancreatic cancer detection within 12 months after the blood draw as the primary outcome and measure the positive predictive value of the assay as a secondary outcome. The study duration extends up to the end of 2028, with safety and diagnostic results followed during this period.

Spinal muscular atrophy SMA is a genetic disorder caused by changes in the SMN1 gene, leading to low SMN protein levels and problems with motor neurons. It is an inherited disease that mainly affects children and is a leading cause of infant death due to genetic conditions. This research aims to observe patients with SMA over time to understand long-term outcomes with new treatments and to evaluate the long-term safety and effects of the investigational therapy OAV-101. This is a prospective, multinational, non-interventional observational study where patients receive their usual clinical care without changes directed by the study. Treatments such as Zolgensma may be given according to normal clinical practice, but this is not controlled by the study protocol. Patients will be followed for up to 15 years or until death, with no extra visits or tests beyond what is normally done for SMA care. Participants will be evaluated through regular clinical assessments based on their normal care schedule, with data collected at baseline and at intervals of every 6 months for the first 2 years, then yearly for up to 15 years. Researchers will measure survival rates, motor function scores like CHOP-INTEND and HFMSE, hospitalizations, quality of life, use of ventilator, nutritional, and mobility supports, as well as any treatment-related side effects during this long-term follow-up.