George

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.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effectiveness and safety of QMF149, a combination of indacaterol acetate and mometasone furoate, compared to budesonide in children aged 6 to less than 12 years with asthma. This Phase 3, double-blind, randomized, active-controlled, two-period, two-treatment cross-over study focuses on children with asthma who have lung function (FEV1) at or above 50% of the predicted normal value. The study aims to show whether QMF149 is superior to budesonide in improving asthma control. The study lasts up to 37 weeks and includes several phases: a screening period of up to 3 weeks, a 3-week run-in period where all participants receive fluticasone propionate, a first 12-week treatment period with either QMF149 or budesonide delivered once daily via Breezhaler, a 3-week washout period with fluticasone propionate, a second 12-week treatment period where participants switch treatments, and a 4-week safety follow-up where patients return to standard care as appropriate. The treatments are given once daily through an inhaler device. Participants attend scheduled visits every 3 weeks during screening and run-in, every 6 weeks during treatment periods, and a follow-up visit after safety monitoring. Assessments include lung function tests (FEV1), inhaler technique checks, symptom questionnaires, and monitoring of side effects. Researchers evaluate changes from baseline in trough FEV1 after each 12-week treatment to measure lung function. Safety information and survival status are collected at the end of the follow-up period.

Researchers are evaluating the safety, immune response, and effectiveness of a new tuberculosis vaccine called MTBVAC in healthy adolescents and adults aged 14 to 45 years who live in areas where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, involving participants with different immune responses to TB exposure as determined by IGRA testing. The study aims to protect against TB disease confirmed by multiple tests and focuses on those who are HIV-negative. Participants will be randomly assigned to receive either a single intradermal dose of the MTBVAC vaccine or a placebo. The vaccine dose contains approximately 5x10^5 colony-forming units, and the placebo is saline solution, both given as 0.1 mL injections. The study includes two groups based on IGRA status: one with prior immune response to TB and one without, with different randomization ratios. Some participants will be part of safety and immune response sub-cohorts for more detailed monitoring. Throughout the 36-month follow-up, participants will attend regular visits or be contacted to check for signs of TB. They will be trained to recognize TB symptoms and report them for further evaluation, including sputum testing using advanced molecular and culture methods. HIV testing will occur yearly and at times of suspected TB. Safety monitoring includes tracking adverse events and laboratory tests in selected subgroups. Participants diagnosed with TB will be referred for treatment according to local guidelines.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the safety and bactericidal activity of TBD09 combined with other drugs in adults with drug-sensitive pulmonary tuberculosis. This Phase 2, open-label, randomized trial aims to assess whether TBD09, when used with bedaquiline, pretomanid, and linezolid, shows potential as a safe and effective treatment option for this condition. Participants are divided into five groups, each receiving different doses or combinations of TBD09 alongside bedaquiline and pretomanid or linezolid for 28 days. Group 1 receives TBD09 100 mg three times weekly, Groups 2 to 4 receive TBD09 daily at increasing doses (100 mg, 300 mg, 500 mg), and Group 5 receives linezolid 600 mg daily instead of TBD09. All treatments are administered daily or three times weekly depending on the group. Throughout the study, participants are monitored for bactericidal activity from randomization through Day 28 and safety from screening through Day 35. Researchers evaluate serious adverse events, treatment-emergent adverse events, adverse events of special interest, and events leading to treatment discontinuation. These assessments help determine the safety and effectiveness of the study treatments over the course of participation.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the bronchodilator effect, systemic exposure, safety, and tolerability of two doses of inhaled glycopyrronium compared to placebo in children aged 6 to less than 12 years with moderate to severe asthma. This Phase II study aims to determine the appropriate dose of inhaled glycopyrronium for developing a fixed dose combination treatment including indacaterol, mometasone, and glycopyrronium for this pediatric population. Participants must have asthma with a forced expiratory volume in one second (FEV1) between 60% and 90% of the predicted normal. The study is a double-blind, placebo-controlled, randomized, three-treatment, three-period, six-sequence crossover trial. It includes four phases: Screening, Run-in, Treatment, and Follow-up. During the Run-in and Treatment phases, participants continue their background asthma controller therapy containing salmeterol xinafoate and fluticasone propionate. The Treatment phase lasts 10 weeks, consisting of three two-week treatment periods with either 12.5 µg glycopyrronium bromide, 25 µg glycopyrronium bromide, or placebo inhaled via Breezhaler capsules. Two-week washout periods separate each treatment period. Participants who stop treatment early will have an Early Termination Visit, and all participants will have a safety follow-up call 30 days after their last treatment. Throughout the study, participants attend clinic visits for assessments including spirometry to measure trough FEV1 at the start and end of each treatment period. Researchers monitor efficacy, pharmacokinetics, pharmacodynamics, safety, and tolerability. Parents or legal guardians complete electronic diaries and attend all visits with the child. Total participation time from screening to follow-up is about 20 weeks, including safety monitoring after treatment ends.