Dasmarinas

Researchers are evaluating the immunogenicity, safety, and consistency of a new fully liquid hexavalent vaccine called LBVD in healthy infants. This vaccine targets diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b. The study compares LBVD with the co-administration of licensed pentavalent and inactivated poliovirus vaccines given as separate injections. The trial includes two stages: Phase 2 to compare immunogenicity and safety, and Phase 3 to confirm non-inferior immunogenicity and lot-to-lot consistency of LBVD. Infants receive three doses of vaccine at 6, 10, and 14 weeks of age through intramuscular injections into the anterolateral thigh. One group receives the LBVD vaccine, while the other receives separate injections of the pentavalent vaccine and inactivated poliovirus vaccine. The study assesses immune responses and safety four weeks after the completion of the three-dose primary vaccination series. Consistency across three separate lots of LBVD vaccine is also evaluated during Phase 3. During the study, infants undergo evaluations of immune response by measuring seroprotection and seroconversion rates, as well as geometric mean concentrations for pertussis at four weeks after completing the three-dose series. Safety monitoring includes observing for adverse events. The total participation period covers vaccination at 6, 10, and 14 weeks and follow-up assessments four weeks after the final dose. Parental consent and monitoring of infants' health and reactions are integral throughout the trial.

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 the safety and immune response of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in children aged 1 to under 12 years. This phase 3, global, randomized, double-blind, placebo-controlled study aims to compare the vaccine with a placebo to understand its effects in this young population. The study focuses on measuring the vaccine's ability to produce antibodies and monitoring safety events over an extended follow-up period. Participants will receive either the CHIKV VLP vaccine, which contains virus-like particles adsorbed on aluminum hydroxide adjuvant, or a placebo consisting of formulation buffer. The vaccination occurs on Day 1, followed by monitoring for adverse events up to Day 29 and immune response assessment on Day 22. The study is planned to continue safety monitoring through Day 732 for those who complete the trial. During the study, children will undergo medical history reviews, physical examinations, and regular safety assessments including recording of any adverse events. Researchers will collect blood samples to measure antibody responses on Day 22 and monitor for any serious or medically significant events throughout the trial. Participants are expected to attend all scheduled visits and comply with study procedures over the course of the study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating new, faster, simpler, and less expensive tests to diagnose tuberculosis (TB) at the point of care. The study focuses on adolescents and adults suspected of having TB based on symptoms or risk factors, aiming to reduce the large number of undiagnosed TB cases and deaths worldwide. The study includes clinical evaluations in outpatient health centers in high TB burden countries and assesses how well these new tests work compared to standard sputum tests recommended by the World Health Organization (WHO). The study will examine molecular tests using samples collected by tongue swabs that can be done near or at the point of care. These tests will be compared against established reference tests like sputum Xpert MTB/RIF Ultra and sputum cultures to measure their ability to correctly identify TB cases. Additionally, the study will explore how usable and acceptable these new tests are by observing and surveying healthcare workers who perform routine TB testing. Participants will be interviewed and examined for TB symptoms and risk factors, and undergo diagnostic testing using both standard and novel methods. The study will monitor the proportion of correct positive and negative test results over two years. Healthcare workers involved in TB testing will also be included to provide feedback on the novel tests. The overall goal is to improve rapid TB diagnosis and treatment by validating these new diagnostic tools and understanding their practical use in healthcare settings.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are studying the safety, tolerability, how the body processes the drug, and anti-mycobacterial effects of bedaquiline (TMC207) in children and adolescents from birth up to less than 18 years old who have confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB). The study combines bedaquiline with a background regimen of MDR-TB medications following standard treatment guidelines. This is a Phase 2, open-label, multicenter, single-arm study. Participants receive bedaquiline in different dosages depending on their age group (four cohorts). For example, cohort 1 gets an adult tablet of 400 mg once daily for 2 weeks followed by 200 mg three times a week for 22 weeks. Younger cohorts receive age-appropriate doses, with administration schedules ensuring at least 48 hours between doses. The background MDR-TB medication regimen is given according to World Health Organization and local guidelines throughout the study. Participants are closely monitored through blood tests measuring drug levels at multiple times up to 120 weeks for some cohorts and up to 88 weeks for others. Researchers will also track adverse events and serious adverse events during the study. Other measures include maximum and minimum plasma concentration, time to peak concentration, drug clearance, and half-life. The total study duration varies by cohort, with ongoing safety and pharmacokinetic assessments to understand the drug's behavior and effects in children and adolescents with MDR-TB.