Chia

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 different treatment strategies for patients hospitalized with Gram-negative bloodstream infections (GN BSIs) through the BALANCE+ trial. This adaptive platform trial uses an open-label, pragmatic design embedded in routine care to address important questions in managing GN BSIs, including antibiotic treatment duration, antibiotic de-escalation, oral antibiotic options, central line management, specific pathogen treatment, and follow-up blood cultures. The study builds on previous research and aims to improve patient outcomes and reduce antimicrobial resistance, a growing global health concern. The trial includes multiple treatment comparisons, such as de-escalation versus no de-escalation of antibiotics, oral beta-lactams versus non-beta-lactams, central vascular catheter retention versus replacement, cephalosporin versus carbapenem for low-risk AmpC organisms, and routine follow-up blood cultures versus no routine follow-up. Treatments are tailored based on blood culture results and clinical decisions, with specific protocols for antibiotic switching and catheter management. The trial uses Bayesian methods with interim analyses after every 1000 patients initially, then every 200 patients, and stops domains based on predefined criteria or sample sizes. Participants are patients admitted to hospitals with confirmed Gram-negative bacteremia who meet eligibility criteria for each domain. Assessments include monitoring for death, reinfection, readmission, and new antimicrobial resistance over 90 days, measured by the Desirability of Outcome Ranking (DOOR) scale. The trial incorporates detailed inclusion and exclusion criteria and collects data through routine clinical care, ensuring ongoing evaluation of treatment effectiveness and safety throughout the study period.

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 a new device called the laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) to measure laryngopharyngeal mechanosensitivity in patients suspected of having obstructive sleep apnea (OSA). This prospective, double-blinded, randomized crossover trial aims to validate the accuracy and reliability of this sensory test compared to standard baseline polysomnography results. The study also explores sensory threshold differences among patients with varying severity of OSA and investigates correlations between sensory thresholds and OSA severity. Participants will undergo a laryngopharyngeal sensory test using the LPEER device, which delivers controlled air-pulses to measure psychophysical sensory thresholds at the velopharynx, hypopharynx, and aryepiglottic folds. The testing involves sequences of 10 air-pulses at different intensities to assess sensory and reflex responses. The study includes a crossover design with randomized raters to evaluate both intra- and inter-rater reliability of the sensory measurements. During the study, participants will be assessed for sensory thresholds at three specific airway locations. The researchers will analyze reliability using statistical methods and diagnostic accuracy using ROC curves based on baseline polysomnography. Sensory threshold values will be compared among mild, moderate, and severe OSA groups. The study also involves monitoring participant cooperation and safety, with total involvement including baseline polysomnography and sensory testing typically performed on the same or next day.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.

Researchers are studying the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus who test positive for anti-nuclear antibodies. This extension study involves participants who previously completed treatment in one of two core SIRIUS-SLE studies. The aim is to monitor how well ianalumab is tolerated over an extended period compared to a placebo. The study compares monthly or quarterly subcutaneous injections of ianalumab to monthly placebo injections. Participants receive these treatments after completing the initial core studies (CVAY736F12301 or CVAY736F12302). This extension phase focuses on continued monitoring of these treatments over a long time frame. Participants will be observed for treatment-emergent adverse events and serious adverse events for up to approximately 91 months. Assessments include monitoring safety and tolerability throughout the study period. The total participation duration depends on individual study completion, with ongoing evaluation to ensure participant well-being during this extended follow-up.

Researchers are evaluating new treatments for acute hypoxemic respiratory failure (AHRF), a serious condition affecting millions worldwide and often requiring mechanical ventilation or extracorporeal life support. This adaptive platform trial includes multiple domains that assess different therapies across a range of patient severity and investigational phases, from early mechanistic studies to full clinical trials. The study uses advanced statistical methods to efficiently test interventions focusing on mechanical ventilation, extracorporeal support, drugs, and medical devices. Participants may receive various interventions depending on the domain, including ultra-protective ventilation using VV-ECMO, lung-protective ventilation, driving pressure-limited ventilation, lung- and diaphragm-protective ventilation with sedation, corticosteroid treatments, fludrocortisone, nebulized furosemide, or inspiratory muscle training. Some domains also study ventilation strategies during extracorporeal life support or collect observational data. Treatments are delivered according to randomized assignments, sometimes involving specialized devices or adjusted ventilator settings. During the study, participants undergo assessments including physiological and biological measurements, monitoring of ventilation targets, adherence to protocols, and survival outcomes up to 60 days. Recruitment feasibility and barriers are tracked over years at multiple sites. The trial collects data on ventilator-free days, mortality, advanced respiratory support-free days, and protocol adherence. Safety and effectiveness are regularly evaluated through Bayesian adaptive analyses, with total enrollment periods ranging from months to years depending on the domain.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

This research aims to assess the long-term safety of secukinumab in participants who have finished a previous Novartis secukinumab trial and are judged by their investigator to benefit from continued treatment but cannot access the marketed secukinumab form. The study focuses on individuals with autoimmune or inflammatory conditions and is conducted as a Phase 4 trial to monitor treatment safety over an extended period. Participants will receive secukinumab through subcutaneous injections using pre-filled syringes. The study is open-label and multi-center, designed for patients continuing secukinumab therapy after completing a parent study or in cases where the parent study ended prematurely for non-safety reasons. Treatment continuation depends on investigator judgment regarding benefit and risk balance. During the study, participants will be observed for up to two years to evaluate safety by tracking any adverse or serious adverse events. The study includes regular assessments to monitor participant health and treatment effects. Consent and communication with investigators are essential, and participants may sign informed consent or assent forms according to age and local laws. Overall participation duration and detailed safety monitoring are key components of the study.