Bungoono

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

Researchers are evaluating the safety and effectiveness of trontinemab in people with early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimer's. This Phase III study is designed to better understand how trontinemab affects cognitive decline in this population. Participants have confirmed Alzheimer's disease pathology and meet specific clinical criteria related to memory and cognitive function. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. Treatment will be given over a defined period, and participants will be monitored closely throughout. During the study, participants will undergo various assessments including MRI scans, clinical genotyping, and PET imaging or cerebrospinal fluid tests to confirm disease status. Cognitive tests such as the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating are used to track changes. Researchers will measure the change in Clinical Dementia Rating Sum of Boxes from baseline to week 72 to evaluate treatment effects. Safety and tolerability will also be monitored throughout the study duration.

Researchers are investigating the effects of CSL787, an inhaled immunoglobulin G solution, in adults with Non-cystic Fibrosis Bronchiectasis (NCFB). This phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to explore the efficacy, safety, and tolerability of two different doses of CSL787 compared with placebo over 6 to 12 months. The main goal is to assess how CSL787 may delay the time to first pulmonary exacerbation in these patients. Participants will receive either a high or low dose of CSL787 or a matching placebo once daily via a nebulizer device for 6 to 12 months. The nebulizer used is a CE-marked device. The study includes two active treatment regimens to evaluate the dose response and overall impact of the inhaled treatment on disease exacerbations. During the study, participants will be monitored for exacerbations, lung function, and safety outcomes. The primary measure is the time to first exacerbation within 12 months. Participants will undergo lung function tests according to standardized guidelines and may have chest CT scans if needed to confirm diagnosis. Researchers will track symptoms and treatment tolerability throughout the study period.

Colorectal cancer (CRC) is a major health concern worldwide, ranking third in diagnosis and second in mortality. This research aims to develop a new blood test that can detect early signs of colorectal adenomas and cancer with high sensitivity and specificity, using advanced biological analyses and machine learning. Current screening methods like fecal immunochemical testing detect cancers but not precursor adenomas well, while endoscopy is invasive and costly. A non-invasive blood test could improve early detection and patient participation. The study will develop a liquid biopsy test called DENEB that measures circulating microRNA from both cell-free and exosome-derived sources in blood samples. It will proceed in four phases: profiling microRNA to select biomarker candidates, using machine learning to develop detection algorithms for adenomas and cancer separately, combining these algorithms into a single test, and validating the test in diverse patient groups. This blood test aims to detect advanced adenomas and colorectal cancer from a single blood draw, optimizing sensitivity, specificity, and cost-effectiveness. Participants will have had a colonoscopy and standard diagnostic procedures before any treatment, with at least one blood sample taken before treatment. Researchers will measure the test's sensitivity over about one year of study completion. The study will compare the new blood assay to standard care and validate its performance in multiple cohorts. Success could lead to improved early detection and prevention of colorectal cancer through a simple, non-invasive blood test.

Early-onset colorectal cancer (EOCRC), which is colorectal cancer diagnosed before age 50, has been increasing in young adults and now accounts for 10-15% of new cases. It is a leading cause of cancer-related death among young men and women. Screening challenges include low compliance and the invasive nature of standard tests, so this study aims to develop a non-invasive, blood-based test to improve early detection and participation. Researchers are evaluating a liquid biopsy test called ENCODE that measures microRNAs from blood plasma, including both cell-free and exosomal microRNAs. Using advanced machine learning and bioinformatics, the study will develop and validate panels combining these microRNAs to create a highly sensitive and specific diagnostic biomarker for EOCRC. The study will proceed in three phases: RNA sequencing, panel development and training, and validation in an independent group. Participants will provide plasma samples before any treatment. The study will assess sensitivity over about one year. Researchers will analyze microRNA expression, apply machine learning models, and compare results between EOCRC patients and cancer-free controls proven by colonoscopy. This approach aims to offer a cost-effective, patient-friendly screening method to improve early detection and reduce mortality from EOCRC.

This research aims to confirm the safety and effectiveness of Fasenra40 mg / 10 mg Syringe when used by pediatric patients with bronchial asthma in real-world post-marketing settings. The study focuses on identifying any unexpected drug-related adverse events, understanding the occurrence of related adverse events, and evaluating lung function and asthma control in children who have intractable bronchial asthma that is not controlled by existing treatments. Participants will be children aged 6 to under 15 years who are treated with Fasenra for the first time. The investigation observes the use of the subcutaneous injection of Fasenra as it is prescribed in typical clinical practice without additional interventions or comparator groups. Since this is a post-marketing study, treatments follow usual care and monitoring procedures. During the study, researchers will monitor participants for adverse drug reactions from the start of treatment through one year. They will assess lung function and asthma control to evaluate treatment effectiveness. The study involves collecting safety and effectiveness data under actual use conditions, supporting regulatory review and ensuring ongoing product safety for pediatric users.

Researchers are evaluating the safety and clinical effects of Awiqli (Insulin Icodec) in people with diabetes mellitus in Japan during routine clinical care. This study aims to understand how Awiqli works and how safe it is when used in real-world medical settings. Both men and women of any age with a diabetes diagnosis can participate, and the study will last about one year. Participants will receive Awiqli as prescribed by their treating doctor according to usual medical practice. The treatment involves using commercially available Awiqli once weekly. This is a single-group, open-label, non-interventional study, meaning there is no placebo or comparison group and the treatment is given as part of normal care. Throughout the 52-week study, researchers will collect data on any adverse reactions from the start until the end of the study. Participants will be monitored for safety and clinical outcomes as they use Awiqli. The study includes regular follow-up to assess treatment effects and collect safety information over the full year.

Researchers are evaluating a treatment protocol using blinatumomab for infants under 1 year old diagnosed with acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia who have a specific genetic change called KMT2A-rearrangement. This study aims to improve outcomes for these very young patients with this challenging disease. The trial is a Phase 3 international collaboration focusing on this rare population. All enrolled infants will receive one cycle of blinatumomab after their initial induction therapy, alongside standard treatment. Medium risk patients who respond well to the first cycle may receive a second cycle replacing one chemotherapy course after consolidation therapy. Those who do not respond well will follow the current standard treatment. High risk patients who become minimal residual disease (MRD) negative after the first blinatumomab cycle may be eligible for allogeneic stem cell transplantation. MRD levels guide treatment decisions throughout the protocol. Participants will be closely monitored with assessments including MRD testing to measure response to treatment. The main outcome measured is event-free survival over 5 years. Parents or legal guardians will provide informed consent prior to enrollment. The study involves continuous intravenous infusion of blinatumomab over four weeks per cycle and follows infants through treatment and follow-up to evaluate long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of peficitinib in patients with rheumatoid arthritis (RA) receiving treatment in routine clinical practice. This mandatory Post-Marketing Surveillance (PMS) study is conducted as part of the Japan Risk Management Plan (J-RMP) and requested by the Pharmaceuticals and Medical Devices Agency (PMDA). The aim is to collect real-world data on patients treated with peficitinib for RA. The study involves treatment with oral peficitinib, given as part of routine clinical care. There are no comparator groups; all participants will be patients receiving peficitinib for the first time. The study focuses on monitoring safety and effectiveness in an actual clinical setting without altering the standard treatment schedule. Participants will be followed for up to 156 weeks to assess safety outcomes such as the frequency of adverse events, serious infections, malignancies, and events leading to death. Effectiveness will be measured up to 52 weeks using disease activity scores including DAS28 (using C-reactive protein and erythrocyte sedimentation rate), Simplified Disease Activity Index, Clinical Disease Activity Index, tender and swollen joint counts, and global assessments by patients and physicians. Researchers will also evaluate EULAR response criteria and remission rates. This long-term follow-up provides comprehensive safety and effectiveness data in real-world RA treatment.