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Researchers are studying a treatment called MK-2214 to see if it can slow certain brain changes in people with early Alzheimer's disease (AD). AD is a form of dementia that causes memory loss, difficulties with communication, and challenges in decision-making, which affect daily activities. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the safety and tolerability of MK-2214. Participants will receive either MK-2214 or a placebo through an intravenous (IV) infusion. The study is designed as a phase 2, randomized, placebo-controlled, double-blind trial with parallel groups. The treatment period lasts up to about 23 months, during which participants will receive infusions as scheduled. The placebo looks like the study treatment but contains no active drug, helping researchers understand the treatment's effects. Throughout the study, participants will be monitored for changes in tau protein levels in the brain using PET scans and for any adverse events or side effects. Researchers will track the number of participants experiencing adverse events and those who stop treatment because of them, with safety follow-up lasting up to approximately 26 months. Participants will also undergo brain imaging such as CT, PET, or MRI scans. The study involves regular assessments to measure the treatment's impact and ensure participant safety over the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This research aims to evaluate the effectiveness and safety of an oral drug called ozanimod (RPC1063) in treating children and teenagers aged 2 to 17 years who have moderate to severe active ulcerative colitis (UC). These young participants have not responded well to standard treatments, and the study focuses on helping them achieve and maintain clinical remission of their condition. Participants will receive specified doses of ozanimod by mouth according to a set schedule. The study is a Phase 2/3, randomized, double-blind trial conducted at multiple centers. The goal is to assess how well ozanimod works and how safe it is in this pediatric population with UC that extends beyond the rectum. During the study, researchers will monitor participants closely through medical assessments, including endoscopy to confirm disease extent and other evaluations to track disease remission. The main outcome measured is the proportion of participants who reach clinical remission by Week 52. Safety and drug behavior in the body will also be observed throughout the trial period.

Researchers are evaluating the safety and tolerability of a drug called LY4006895 in a study involving healthy adults and patients with early symptomatic Alzheimer's Disease (AD). This Phase 1 trial includes two parts: Part A focuses on healthy participants receiving single-ascending doses, and Part B involves participants with early AD receiving multiple-ascending doses. The study aims to understand how LY4006895 behaves in the body by measuring blood levels and elimination over time. Participants in Part A will receive single intravenous doses of LY4006895 or placebo, while those in Part B will receive multiple intravenous doses following a schedule. The study lasts about 29 weeks for Part A and up to 61 weeks for Part B, including screening periods. Both parts monitor participants closely for any adverse effects and drug-related safety concerns. During the trial, participants will undergo various assessments including blood tests to track drug levels, cognitive evaluations, and safety monitoring. Up to two reliable study partners will support participants with early AD by attending visits and providing information. Researchers will record any treatment-emergent adverse events, serious adverse events, or discontinuations related to the study drug from baseline through study completion to evaluate safety and tolerability.

Researchers are evaluating the safety and tolerability of the drug rozanolixizumab, given by subcutaneous injection, in children aged 2 to under 18 years who have moderate to severe generalized Myasthenia Gravis (gMG). This is an open-label, single-arm study designed to assess the drug's activity, safety, and how it is processed by the body in this pediatric population. Participants must have a confirmed diagnosis of gMG with specific antibodies and have experienced insufficient response or worsening symptoms on conventional treatments. Participants will receive rozanolixizumab as an injection under the skin. The study does not include a comparison group, and all enrolled children will be treated with this medication. Treatment will be monitored carefully throughout the study period, which can last up to 18 weeks. The study is conducted in phases 2 and 3, focusing on young patients with this condition. During the study, researchers will monitor participants for any serious side effects or treatment-emergent adverse events, including those that lead to stopping the medication or require special monitoring. Safety assessments will continue through the end of the study visit, which may last up to 18 weeks from baseline. The study involves close observation of participants' health status, antibody presence, and symptom changes to evaluate how well the medication is tolerated and its safety profile in children with generalized Myasthenia Gravis.

Crohn's Disease (CD) is a gastrointestinal condition that can cause chronic diarrhea, abdominal pain, weight loss, and fever. This study is evaluating the pharmacokinetics, effectiveness, and safety of risankizumab in children aged 2 to less than 18 years with moderately to severely active CD who have not responded well or are intolerant to other treatments. Risankizumab is already approved for adults with certain inflammatory conditions and is being studied here for pediatric CD in a Phase 3 trial. The study includes three groups (cohorts) based on age ranges: 6 to less than 18 years, 2 to less than 6 years, and 2 to less than 18 years. Participants start with an open-label induction period where they receive intravenous risankizumab over 12 weeks. Next, in a double-blind maintenance period lasting 52 weeks, they receive subcutaneous risankizumab at one of two doses. Following this, there is an open-label extension phase of 208 weeks with ongoing subcutaneous risankizumab treatment. Participants will visit hospitals or clinics regularly for medical assessments including blood tests, monitoring for side effects, and questionnaires to evaluate treatment effects. The study will measure outcomes such as clinical remission rates and endoscopic response at 64 weeks. Safety and how the drug moves through the body will also be tracked for up to about 64 weeks, with a follow-up period of approximately 140 days. The total involvement may involve higher treatment burden compared to usual care.

This research aims to evaluate the long-term safety and tolerability of brivaracetam in children and adolescents with epilepsy. It includes pediatric participants who previously took part in neonatal or long-term follow-up studies, as well as new participants from Japan with partial-onset seizures. The study also includes evaluation of pharmacokinetics in Japanese participants. It is a Phase 3, open-label, single-arm, multicenter study focusing on pediatric epilepsy patients treated with brivaracetam as an additional therapy. Participants will receive brivaracetam orally twice daily, either as tablets available in 10 mg, 25 mg, or 50 mg strengths, or as an oral solution with a concentration of 10 mg/ml. The treatment is administered in two equal doses each day. The study includes those previously enrolled in related studies and new enrollees from Japan, with treatment and monitoring continuing over an extended period to assess long-term safety. During the study, researchers will monitor participants from the initial evaluation visit through safety visits that may last up to five years. They will track any adverse events related to treatment, including serious events and those causing discontinuation of the drug. Assessments include clinical evaluations, laboratory tests, and electroencephalogram readings, with ongoing safety monitoring to understand how well participants tolerate the medication over time.

Researchers are investigating the effects of starting finerenone treatment early during hospitalization for patients with acute heart failure who have a left ventricular ejection fraction of 40% or higher. This Phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether early use of finerenone can improve outcomes in this patient group. Participants are randomly assigned to receive either finerenone or a matching placebo tablet. The finerenone dosing depends on kidney function: patients with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m² or less start at 10 mg once daily, with a maximum dose of 20 mg once daily; those with eGFR above 60 mL/min/1.73 m² start at 20 mg once daily, with a maximum dose of 40 mg once daily. Treatment begins within 36 hours after hospital admission, with randomization occurring within 24 hours. During the study, participants will be monitored for up to 12 weeks to evaluate a combined outcome of death and worsening heart failure. Researchers will conduct assessments including physical exams, symptom evaluation, laboratory tests, and heart function measurements. Safety and adherence to treatment will be tracked throughout the study, ensuring comprehensive evaluation of the therapy's impact during the critical early phase of hospitalization.

Researchers are conducting a multicenter, single-arm, non-interventional survey to study the safety of Entresto Tablets or Entresto Granules in pediatric patients with chronic heart failure in Japan. The study focuses on observing these patients in real-world clinical settings and aims to collect information about safety concerns, such as hypotension, hyperkalemia, renal impairment, and dehydration. The observation period lasts for up to 52 weeks after starting treatment. The study involves pediatric patients aged 1 to under 18 years who are receiving Entresto for chronic heart failure for the first time. It monitors the administration of Entresto, including details about accidental use of the granules in capsule-shaped containers. This long-term observation helps researchers understand risk factors related to safety events and the overall status of Entresto use in this young population. Participants will be followed for one year, during which researchers will observe and record any events related to the safety of the medication. The main focus is on tracking occurrences of hypotension, high potassium levels, kidney problems, and dehydration. Safety monitoring includes collecting data on these events and understanding their relationship to Entresto use in children with chronic heart failure.

Researchers are evaluating the effects of KK8398 on growth in children and adolescents with achondroplasia, a genetic condition affecting bone growth. This Phase 3, open-label, single-arm study aims to measure how KK8398 influences annualized height velocity over 52 weeks of treatment. KK8398 will be given repeatedly to patients aged between 2.5 and 17.5 years who have a confirmed genetic diagnosis of achondroplasia and meet specific developmental criteria. The study involves a single treatment group receiving KK8398 with no placebo or comparator groups. Treatment effects will be assessed after one year of administration. Participants will be monitored for changes in height growth from the start of the study to Week 52. Researchers will track growth rates and collect safety information throughout the treatment period. The total study duration for each participant is 52 weeks, during which height velocity is the primary outcome measure.