Chia

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating various treatment strategies for Gram-negative bloodstream infections GN BSIs in a large, ongoing platform trial called BALANCE. This trial aims to improve treatment methods, patient outcomes, and reduce antimicrobial resistance. It builds on previous research and uses an adaptive design to answer critical questions about managing these serious infections in hospitalized patients. The trial studies different treatment approaches including antibiotic de-escalation, oral beta-lactam versus non-beta-lactam antibiotics, whether to replace or retain central vascular catheters, selecting cephalosporins or carbapenems for specific bacteria, and the use of routine follow-up blood cultures. Participants are randomly assigned to one of these treatment strategies within each domain, with ongoing adjustments based on interim analyses. The initial pilot study has completed, and all patients from that phase are included in the main trial. Participants will be monitored over 90 days for outcomes including death, reinfection, hospital readmission, and development of new antimicrobial resistance. Evaluations include laboratory tests, clinical assessments, and tracking of antibiotic use and patient health status. The trial uses a ranking scale combining these outcomes to determine the desirability of each treatment strategy. This adaptive platform design allows continuous learning and refinement of treatments to improve care for people with GN BSIs.

Researchers are studying the accuracy of a new device called the laryngopharyngeal endoscopic esthesiometer and rangefinder LPEER to measure throat sensitivity in patients suspected of having obstructive sleep apnea OSA. This prospective, double-blinded, randomized crossover trial aims to validate this devices measurements by comparing them to standard sleep study results. The study focuses on understanding sensory differences in patients with mild, moderate, and severe OSA and improving knowledge about OSAs underlying mechanisms. The study involves patients referred for a baseline sleep test who will undergo a sensory test using the LPEER, which delivers air pulses of varying intensity to specific throat areas the velopharynx, hypopharynx, and aryepiglottic folds. Experienced and less experienced pulmonologists or otolaryngologists will perform these tests to assess measurement reliability. The study design includes randomized crossover assignment of raters to evaluate intra- and inter-rater agreement and diagnostic accuracy through detailed statistical analyses. Participants will attend the sleep laboratory where they will receive the sensory test alongside their routine sleep study. Researchers will measure sensory thresholds at three throat sites and collect data related to sleep apnea severity, oxygen levels, and any adverse events. The study will last up to 15 days for each participant, during which safety and test accuracy will be closely monitored. Results will help determine the usefulness of LPEER for future clinical evaluation and monitoring of OSA patients.

Researchers are evaluating the safety and effectiveness of IMVT-1402 in adults with moderate to severe primary Sjogrens disease, a condition characterized by systemic symptoms. This Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study aims to compare IMVT-1402 to a placebo by measuring changes in disease activity at 24 weeks. Participants will receive weekly subcutaneous injections of either IMVT-1402 at one of two doses or a placebo. The study includes a treatment phase with dosing and monitoring, followed by ongoing participation lasting up to 105 weeks total for each individual. Throughout the study, participants will undergo regular assessments including clinical disease activity scoring using the Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index clinESSDAI. Additional evaluations include physician assessments of disease activity and antibody testing. Safety and tolerability will be closely monitored during the entire study duration.

Researchers are evaluating the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus SLE who have previously completed treatment in one of two core SIRIUS-SLE studies. This Phase 3 extension study compares monthly or quarterly subcutaneous ianalumab to monthly placebo in participants who are positive for anti-nuclear antibodies ANA. The study aims to understand how ianalumab performs over an extended period in this patient group. Participants receive ianalumab either monthly or quarterly via subcutaneous injection, or a monthly placebo injection, throughout the extension study. Only those who completed the initial 60-week treatment period of the core studies without discontinuation are eligible. The study involves random assignment to one of the three groups and follows a quadruple-blind design to ensure unbiased results. During the trial, participants are monitored for treatment-emergent adverse events and serious adverse events up to approximately 91 months. Researchers also assess lupus disease activity, damage progression, corticosteroid use, and flare rates. Safety and tolerability are closely observed through regular evaluations, with the study lasting until April 2032, allowing for comprehensive long-term data collection.

Researchers are evaluating new treatments for acute hypoxemic respiratory failure AHRF, a serious condition that affects millions worldwide each year and carries high risks of death and long-term health problems. This platform trial, called PRACTICAL, uses adaptive methods to test various interventions at different stages, including mechanical ventilation approaches, extracorporeal life support, drugs, and medical devices. The study aims to find better strategies to protect lungs and diaphragm function during ventilation and improve patient outcomes. The trial includes multiple domains studying different treatments or strategies. These include ultra-protective ventilation using extracorporeal carbon dioxide removal, various invasive mechanical ventilation strategies, corticosteroid use in early and extended phases, nebulized furosemide, positive end-expiratory pressure settings during extracorporeal support, fludrocortisone for airspace disease, and inspiratory muscle training. Some domains are observational, collecting data and biomarkers in immunocompromised patients or examining patient-ventilator interactions. Participants will be randomized to different treatment arms or observed, depending on the domain. Participants will undergo assessments including physiological and biological measurements, mechanical ventilation monitoring, and evaluation of clinical outcomes such as mortality, ventilator-free days, organ failure, and long-term cognitive and physical function. Data will be collected daily or at specified time points up to 180 days. The study uses Bayesian adaptive analysis to efficiently evaluate efficacy and safety of interventions. The total participation time varies by domain but includes active treatment periods, follow-up, and feasibility assessments over months to years.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

This trial focuses on participants with autoimmune or inflammatory conditions who have previously taken part in a Novartis secukinumab study. It aims to evaluate the long-term safety of continuing secukinumab treatment in those who the investigator judges will benefit and who cannot obtain the marketed secukinumab formulation. The study is an open-label extension phase 4 trial sponsored by Novartis Pharmaceuticals. Participants will receive secukinumab injections under the skin at doses of 75 mg, 150 mg, or 300 mg every four weeks, depending on their dose in the prior trial. For those who had intravenous secukinumab, the starting dose will be 300 mg subcutaneously. Dosing may be adjusted based on clinical need and investigator judgment. Pediatric dosing will not exceed the maximum dose evaluated for their weight group in the previous trial. During the study, participants will be monitored for up to two years to assess safety, focusing on adverse events and serious adverse events. They will have regular assessments including communication with investigators and follow study requirements. The total study duration extends up to April 2030, with ongoing evaluation to ensure participants continue to benefit from treatment while monitoring for any risks.