Kagoshima

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.

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 evaluating the tolerability and safety of OJP-001, a combined therapeutic system using photodynamic therapy (PDT) with OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study aims to determine the recommended dose and pharmacokinetics of OMD-001, as well as assess the efficacy and safety of OJP-001 in this patient population. This is a Phase I/II trial focusing on patients with recurrent or relapsed ATL with peripheral blood tumor involvement. In the Phase I part, patients receive a single oral dose of 5-ALA at increasing doses (10, 20, 40, or 60 mg/kg) followed by one administration of the photodynamic system (OJP-001). In the Phase II part, patients are treated with 5-ALA and the photodynamic system once weekly for six months. This study evaluates different dosing levels during Phase I and then continues with weekly treatments in Phase II to monitor longer-term effects. Participants will undergo assessments including response evaluation over 24 weeks in Phase II and monitoring for dose-limiting toxicities over 2 weeks in Phase I. Researchers will monitor safety, pharmacokinetics, and treatment response. The study includes laboratory tests, clinical evaluations, and safety observations throughout the treatment periods to evaluate the best overall response and tolerability of the therapy in patients with ATL.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout 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.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

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 the effectiveness and safety of zanidatamab combined with a physician's choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer. This study focuses on participants whose cancer has progressed or who cannot tolerate previous treatment with trastuzumab deruxtecan (T-DXd). The study is a phase 3 randomized trial aiming to assess progression-free survival and other important outcomes such as patient-reported tolerability and physical functioning. Participants receive either zanidatamab or trastuzumab through intravenous infusion, alongside chemotherapy drugs chosen by their physician from eribulin, gemcitabine, vinorelbine (all intravenous), or oral capecitabine. The study includes detailed monitoring of drug safety and how the body processes zanidatamab. The treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including scans to measure cancer progression according to RECIST guidelines. Researchers also monitor safety through laboratory tests and heart function assessments. Participants are followed for up to approximately 44 months to measure progression-free survival and overall treatment outcomes. Long-term follow-up and patient-reported outcomes help provide a complete understanding of the treatments' effects.