Layton

Researchers are evaluating how tirzepatide affects body weight and cardiovascular risk factors in adolescents with obesity who also have multiple weight-related health issues. This Phase 3 study aims to assess the safety and effectiveness of tirzepatide combined with healthy nutrition and physical activity. The study includes adolescents aged 12 to 17 years with obesity defined by a high body mass index (BMI) and at least two weight-related comorbidities such as hypertension, prediabetes, or high triglycerides. Participants will receive either tirzepatide or a placebo, both administered by subcutaneous injection once weekly during the primary 72-week study period. Alongside medication, all participants will follow lifestyle interventions focusing on nutrition and physical activity. After completing the initial 72 weeks and a 4-week safety follow-up, eligible participants who have not been off treatment for more than 12 weeks can continue tirzepatide treatment for an additional 156 weeks with ongoing lifestyle support. Throughout the study, up to 23 visits will monitor participants' BMI changes and improvements in weight-related health conditions. Researchers will measure the percentage change in BMI and assess whether participants show significant improvement or normalization in at least two comorbidities without new or worsening conditions over 72 weeks. Safety and efficacy will be closely tracked during the treatment periods and follow-up visits to understand tirzepatide's impact on adolescent obesity and related health risks.

Researchers are evaluating the immune response consistency of three different lots of GSK's investigational varicella vaccine (VNS Vaccine) in healthy children aged 12 to 15 months who have neither had chickenpox nor received varicella vaccination. The study also compares the safety and immune response of the VNS vaccine with an approved varicella vaccine called Varivax. This is a Phase 3a, observer-blind, randomized controlled trial focused on chickenpox prevention in this young population. Participants will receive one of the three lots of the investigational varicella vaccine or one of two lots of the marketed Varivax vaccine, all given by subcutaneous injection. Alongside these vaccinations, some children may also receive other vaccines such as MMR, hepatitis A, or pneumococcal conjugate vaccines (PCV 13, PCV 20, or Vaxneuvance) depending on national immunization schedules and availability. These vaccines are given either subcutaneously or intramuscularly. The study monitors immune responses following vaccination to assess consistency between lots and compares the investigational vaccine to the approved one. During the study, children will be closely monitored with evaluations of their immune response to the varicella virus, specifically measuring seroresponse and antibody concentrations at Day 43 after vaccination. Safety is also carefully assessed throughout the trial. Parents or guardians will provide consent and support adherence to study requirements, including completion of diaries and attending follow-up visits. The total observation period includes vaccination and follow-up to ensure thorough assessment of immune response and safety in this age group.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in people with moderate-to-severe plaque psoriasis who are also overweight or obese with at least one related health condition. This study is a phase 4, open-label, single-arm trial focused on real-world clinical practice. The goal is to see how well this combination works over a 12-month period. Participants will continue treatment with ixekizumab and start tirzepatide, which is given by injection under the skin. To join, participants must have started ixekizumab about three months before adding tirzepatide. The study monitors treatment beginning at baseline and follows participants for up to one year to assess outcomes. During the study, researchers will measure how many participants improve their skin-related quality of life using the Dermatology Life Quality Index and how many achieve at least a 10% weight reduction after 12 months. Participants will be regularly evaluated to track these outcomes and monitor safety throughout the study period.

Researchers are gathering information on patients with eosinophilic esophagitis (EoE) who have recently started treatment with DUPIXENT4 (dupilumab). This study aims to understand how DUPIXENT is used in everyday medical care for EoE patients. The research also seeks to improve knowledge about EoE to support future studies and treatment decisions for this condition. Participants will receive dupilumab as it is normally prescribed by their healthcare providers, with no additional study drugs provided by the sponsor. The study is observational, meaning the treatment is given as part of standard care without experimental changes. There are no separate treatment groups or interventions beyond regular clinical use. Participants will complete questionnaires that assess how EoE affects their feelings, symptoms like swallowing difficulty, quality of life, and daily activities. Researchers will also collect information on demographics, disease history, medication use, and medical procedures over a period up to three years after starting dupilumab. This helps monitor treatment patterns and disease changes over time.

Researchers are evaluating a clinical decision support (CDS) tool called ePNa, originally designed for emergency departments, to improve pneumonia diagnosis and treatment in urgent care clinics in Utah. This study focuses on adapting ePNa for use in urgent care centers (UCCs), where pneumonia patients are frequently seen, and combining it with Stanford's CheXED artificial intelligence model to enhance chest image analysis. The goal is to implement and test this adapted tool to support clinicians in making accurate and timely pneumonia care decisions, especially as diagnostic and treatment methods evolve during the COVID-19 pandemic. The study involves adapting ePNa to fit the data limitations and workflow of urgent care clinics, incorporating AI-based chest image classification that provides results in less than one second. The adapted tool will be piloted with selected "super user" clinicians and then deployed to one of two randomly chosen UCC clusters, while the other cluster continues usual care. The implementation process will follow the CFIR framework for best practices in integrating new clinical tools, including identifying barriers and facilitators through focus groups, interviews, and workflow observation. Participants include pneumonia patients aged 12 years and older with specific diagnostic codes, and clinicians working in the selected urgent care clinics. The study will collect data on pneumonia diagnosis accuracy, patient transfers to emergency departments, and safety outcomes like unplanned hospital visits and mortality within 30 days. Physician surveys will assess user experience with ePNa. The study is planned to last up to three years, with ongoing monitoring of how ePNa impacts urgent care clinical environments.

Researchers are evaluating the safety and effectiveness of brivekimig in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. This Phase 2b, global, multi-center study is designed as a randomized, double-blind, placebo-controlled trial that tests different doses of brivekimig. The study aims to understand how well brivekimig works compared to a placebo in improving HS symptoms and to find the best dose. Participants will receive either brivekimig or a placebo as a subcutaneous injection. The study includes a dose-ranging phase followed by a maintenance period. The total duration of treatment in the randomized phase can last up to approximately 48 weeks. For those not entering the long-term extension, the study duration will be about 60 weeks, and for those transitioning to the long-term extension, it will be about 52 weeks. During the study, participants will be monitored regularly to assess their response to treatment, including the percentage achieving a clinical response called HiSCR75 by Week 16. Researchers will evaluate safety and efficacy through clinical assessments and follow participants throughout the study period. The total involvement per participant lasts up to around 60 weeks depending on extension study participation.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo in treating bacterial conjunctivitis in both adults and children. This Phase 3 study aims to show that fusidic acid 1% is superior to placebo for this eye infection, while also establishing its safety when applied directly to the eye. Participants will receive either fusidic acid 1% or a placebo ophthalmic solution as part of a randomized, masked treatment. The study is conducted across multiple centers and includes careful monitoring of treatment effects. The main measure of success is clinical cure assessed on Day 4 after starting treatment. During the study, participants will be closely observed for signs of improvement and safety. They must avoid other ocular treatments, cosmetics, and contact lenses during participation. Researchers will confirm bacterial conjunctivitis through clinical signs and tests to exclude viral causes. The total duration and follow-up procedures are designed to thoroughly evaluate treatment outcomes and safety.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).