Loxahatchee Groves

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly 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 KT-621, an oral drug, for its safety and effectiveness in treating adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b randomized, double-blind, placebo-controlled trial aims to understand how KT-621 affects lung function and asthma control compared to a placebo. The study is sponsored by Kymera Therapeutics, Inc. and seeks to provide detailed information on KT-621s behavior in the body and its tolerability. Participants will be randomly assigned to one of four groups receiving different doses of KT-621 or a matching placebo. The treatment period lasts 12 weeks, during which participants take the study drug orally. The trial includes regular assessments to monitor lung function, asthma symptoms, and quality of life, with additional follow-up extending to 16 weeks to evaluate safety and drug levels in the blood. Throughout the study, participants will attend scheduled visits for lung function tests, questionnaires about asthma control and quality of life, and blood sampling to measure drug concentration and monitor safety. Researchers will track changes in lung function from the start through Week 12 and observe any adverse events up to Week 16. Participants are expected to comply with all study visits, treatments, and procedures, including keeping an electronic diary to record relevant health information.

Researchers are evaluating a new treatment approach for children and young adults newly diagnosed with acute myeloid leukemia AML, including those with and without FLT3 gene mutations. The trial compares standard chemotherapy using daunorubicin, cytarabine, and gemtuzumab ozogamicin to therapy with CPX-351, a liposome-encapsulated form of daunorubicin and cytarabine, andor the drug gilteritinib which may block abnormal FLT3 gene function. The study aims to understand which treatment works better and to monitor heart function changes during and after therapy. Participants are assigned to different treatment groups based on their risk and FLT3 mutation status. Treatments include various chemotherapy regimens delivered intravenously and intrathecally, with some groups receiving CPX-351 and others receiving standard drugs. Patients with FLT3 mutations receive additional oral gilteritinib for extended periods, including maintenance therapy up to one year. Hematopoietic stem cell transplantation is also part of the treatment for some high-risk patients following chemotherapy courses. During the study, participants will undergo multiple assessments including blood tests, bone marrow biopsies, imaging scans, and neuropsychological testing to monitor leukemia status and treatment effects. Cardiac function is closely followed using echocardiography and biomarkers. Patient outcomes such as event-free survival, overall survival, minimal residual disease, relapse rates, and treatment safety are tracked for up to three years. The total study participation may extend over several years with ongoing evaluations.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are studying the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

Researchers are evaluating whether eptinezumab can reduce the number of migraine days compared to a placebo in adolescents aged 12 to 17 with chronic migraine. This Phase 3, randomized, double-blind study aims to assess the preventive treatment effects of intravenous eptinezumab in this young population who experience frequent migraines. Participants will be randomly assigned to receive a single intravenous infusion of either eptinezumab 300 mg, eptinezumab 100 mg both doses adjusted by body weight, or a placebo. The study includes a 4-week screening period, followed by a 12-week double-blind treatment phase and an 8-week safety follow-up period. The doses are designed to target adult exposure levels based on weight. During the study, participants will complete a headache electronic diary to track migraine and headache days. Researchers will monitor changes in monthly migraine days over 12 weeks as the primary outcome. Additional assessments include migraine reduction percentages, medication usage, headache severity, disability scores, and blood tests for drug levels and antibodies. Safety and tolerability will be evaluated through the follow-up period, totaling about 24 weeks of participation.

Researchers are evaluating the long-term safety of eptinezumab in children and adolescents aged 6 to 17 years who have chronic or episodic migraine. This phase 3 extension study includes participants who completed prior lead-in studies focused on migraine treatment in this age group. The study aims to monitor how well eptinezumab is tolerated over an extended period in young migraine patients. Participants receive eptinezumab intravenously in one of two dose groups, either 100 mg or 300 mg adjusted by weight. Those who were previously assigned to these doses in the lead-in studies will continue the same dose, while those previously on placebo will be randomly assigned to one of the two doses. Each participant receives three infusions at Weeks 0, 12, and 24 during the open-label extension period. During the study, participants undergo regular assessments including safety evaluations, blood tests for drug levels and antibodies at multiple time points up to Week 44, and migraine disability questionnaires at Weeks 12, 24, and 36. The main outcome is the number of participants experiencing treatment-emergent adverse events. This study runs through April 2028, with ongoing monitoring to ensure participant safety and collect detailed data on treatment effects in this population.

Researchers are evaluating depemokimab as an additional treatment for adults with moderate to severe chronic obstructive pulmonary disease COPD who have uncontrolled symptoms and type 2 inflammation. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in reducing COPD flare-ups compared to a placebo, with the goal of improving patient outcomes. Participants will be randomly assigned to receive either depemokimab or a placebo alongside their standard COPD care. Depemokimab is given as a sterile liquid formulation, while the placebo is a sterile sodium chloride solution. The study is double-blind, meaning neither participants nor researchers know which treatment is given. Treatment and observation will continue for up to 104 weeks, allowing thorough assessment over two years. During the study, participants will undergo regular evaluations including lung function tests, symptom questionnaires like the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring of exacerbations requiring medical attention. Researchers will track the annual rate of moderate to severe COPD exacerbations as the primary outcome. Safety will be closely monitored throughout the trial, and participants health status will be reviewed periodically until study completion, which may last until August 2029.