Las Pinas

Researchers are studying the safety and immune response of the CHIKV VLP vaccine in children aged 1 to under 12 years. This Phase 3 randomized, double-blind, placebo-controlled trial aims to evaluate how well the vaccine works and its safety profile in young children against Chikungunya virus infection. Participants will be randomly assigned to one of four groups two active vaccine groups and two placebo groups. The CHIKV VLP vaccine contains chikungunya virus-like particles combined with an aluminum hydroxide adjuvant. The study includes multiple visits for vaccination and follow-up, with immune responses measured at several time points including Days 15, 22, 183, 366, and 732 after vaccination. Safety is monitored throughout via reports of adverse events and serious events. Children in the study will attend scheduled visits to receive the vaccine or placebo and undergo assessments including blood tests to measure immune response. Researchers will track any side effects from vaccination up to two years after the first dose. The main outcomes focus on immune response by Day 22 and safety events throughout the study. Participants health and adherence to study visits will be closely monitored during the entire trial period, which lasts up to approximately two years.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

Researchers are studying how different partially hydrolyzed, whey-based infant formulas affect growth and digestive comfort in healthy full-term infants. This is a randomized, controlled trial comparing two experimental formulas made with hydrolyzed protein to a control formula containing intact protein. The study aims to understand how these formulas influence infant growth over the first four months and their gastrointestinal tolerance. Participants will receive one of three infant formulas a control formula with intact protein, Experimental Formula 1 with hydrolyzed protein, or Experimental Formula 2 also with hydrolyzed protein but produced using a different milk protein base. These formulas differ slightly in protein content and processing. The study follows infants from enrollment until they reach 4 months of age to assess growth differences and equivalence, while also monitoring for tolerance. During the study, researchers will monitor participants growth through measurements like weight, length, and head circumference at various ages up to 6 months. They will also assess gastrointestinal tolerance, stool patterns, allergy symptoms, and dietary intake through scheduled visits. The primary outcomes focus on growth during the first 4 months. This trial includes regular assessments to track infants health, development, and any allergic or digestive symptoms during their first year.

Researchers are evaluating the safety and efficacy of JNJ-90301900 NBTXR3 activated by radiotherapy, with or without cetuximab, compared to radiotherapy with or without cetuximab alone. This Phase 3 study focuses on elderly participants aged 60 years and older who have locally advanced head and neck squamous cell carcinoma LA-HNSCC and are ineligible for platinum chemotherapy. The study is randomized and open-label, aiming to provide insights for this specific patient group. Participants will be assigned to one of two groups. One group receives an intratumoral or intranodal injection of JNJ-90301900 NBTXR3 at a dose of 33% of the gross tumor volume, followed by radiotherapy alone or combined with cetuximab, based on the investigators choice. The other group receives radiotherapy alone or combined with cetuximab. Radiotherapy is intensity-modulated, delivering 70 Gray over 35 fractions across 7 weeks. During the study, participants will be monitored for up to 48 months following the first randomized participant. Researchers will assess progression-free survival as the primary outcome, measured at 30 months, along with secondary outcomes such as overall survival, local-regional control, distant control, quality of life, safety, response rates, and head and neck cancer-specific survival. Regular assessments include clinical evaluations and quality of life questionnaires to track treatment effects and safety over time.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.