Ibaraki

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, leading to a lower number of platelets and increased risk of bruising or bleeding. This Phase 3 study evaluates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP. The study also investigates how the body processes mezagitamab over an extended period. Participants who completed previous mezagitamab studies TAK-079-3002 or TAK-079-1004 will be invited to join this continuation trial. Eligible participants may receive mezagitamab injections on demand, with treatment courses repeated as needed based on specific criteria and the investigators clinical judgment. The treatment is administered subcutaneously. During the study, participants will visit the clinic several times for assessments. Researchers will monitor safety by tracking treatment-emergent adverse events, and evaluate effectiveness through platelet response and remission rates. Measurements of drug levels and antibodies will also be taken. The study may last up to approximately 108 weeks, allowing detailed long-term follow-up.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating ziftomenib in Japanese patients with relapsed or refractory acute myeloid leukemia AML that has an NPM1 mutation. This Phase 2 study aims to assess the drugs effectiveness, safety, and how it behaves in the body. It is the first trial to administer ziftomenib to this patient group in Japan, with the goal of understanding its potential benefits for patients who have limited treatment options. Participants will take ziftomenib orally once daily. The study will monitor responses every 28 days, continuing treatment until the disease progresses or the patient withdraws. Several secondary measures will assess deeper remission rates, transfusion needs, and duration of response. The study also includes detailed monitoring of adverse events, drug levels in the blood, and patient health indicators during treatment and after discontinuation. During the trial, participants will have regular assessments including disease response evaluations every 28 days and safety checks. Follow-up will continue for up to one year after treatment ends to track overall survival and late effects. Participants will be monitored for side effects, changes in laboratory values, heart function, and overall physical status. The study duration varies but includes ongoing treatment and post-treatment observation to gather comprehensive data on ziftomenibs impact.

Researchers are evaluating the effects of Pemafibrate, given at doses of 0.2 mgday or 0.4 mgday, in patients with hypercholesterolemia who do not respond adequately to statin therapy. This post-marketing Phase 4 clinical trial compares these doses to a placebo to assess efficacy and safety over 12 weeks. The study aims to understand how Pemafibrate impacts cholesterol levels, particularly LDL-C, in this patient group. Participants will be randomly assigned to receive either Pemafibrate at one of the two doses or a placebo, all administered orally once daily for 12 weeks. The trial uses a double-blind, parallel group design, meaning neither participants nor researchers know who receives which treatment. The treatment period is structured to monitor changes in cholesterol levels at multiple time points during the 12 weeks. During the trial, participants will have their LDL-C levels measured at baseline and at 4, 8, and 12 weeks after starting the medication. Additional lipid markers will also be assessed at these times. Safety and response to treatment will be closely monitored, including achievement of lipid management goals. The total participation time covers the 12-week treatment phase with scheduled visits and assessments throughout.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating a potential new medicine called CDR132L to understand its effects on the structure and function of the heart in people living with heart failure. The study focuses on participants with heart failure who have reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This research is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aiming to assess safety and efficacy in this population. Participants will receive an intravenous infusion of either CDR132L or a placebo once every four weeks for 48 weeks. Alongside this, all participants will continue their individually tailored guideline-directed standard of care therapy for heart failure. The studys main phase covers these 48 weeks of treatment, followed by monitoring adverse events up to week 60. During the approximately 60-week study, participants undergo evaluations including echocardiography and blood tests measuring biomarkers like microRNA-132-3p and NT-proBNP. Researchers will track changes in heart structure and function, adverse events, and safety throughout the study. The primary outcome focuses on changes in normalized microRNA-132-3p levels from baseline to week 24, while secondary outcomes include measures of heart volume and biomarkers, plus adverse event counts.

This research aims to evaluate how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study compares different doses of CDR132L to a placebo, with treatment assignment determined randomly. It is a phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Novo Nordisk AS, lasting about 60 weeks. Participants will receive intravenous infusions of one of three doses of CDR132L or placebo once every 4 weeks for 48 weeks. Alongside the study drug or placebo, participants will continue their individually adapted guideline-directed standard of care therapy for heart failure. This treatment period is followed by an extension phase to monitor safety and efficacy. During the study, participants will undergo assessments including measuring the change in normalized microRNA-132-3p levels from baseline to week 24, as well as cardiac magnetic resonance imaging to evaluate heart structure changes and blood tests like NT-proBNP levels. Safety is monitored by recording adverse events up to week 60. The total participation duration is approximately 60 weeks, involving regular infusions and follow-up visits.

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.

Researchers are studying the effects and safety of different doses of a new medicine called NNC0662-0419 in people with type 2 diabetes. This study compares NNC0662-0419 with semaglutide, an approved diabetes medication, and a placebo to find out if NNC0662-0419 is an effective and safe treatment option. Participants will be randomly assigned to receive one of these treatments. Participants will receive their assigned treatment by weekly injections under the skin. The study includes groups receiving NNC0662-0419 with increasing doses, semaglutide, or placebo matched to the investigational medicines. Treatments will be given once a week during the study period. During the study, participants will have their blood sugar control monitored by measuring glycated hemoglobin HbA1c at various time points up to 40 weeks. Researchers will also track changes in body weight, blood sugar levels, cholesterol, kidney function, and the number of adverse events. The study lasts until about 48 weeks, allowing for safety and effectiveness assessments throughout this time.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.