Loxahatchee Groves

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effects of SAR445399 compared to a placebo in adults aged 18 to 80 years who have non-cystic fibrosis bronchiectasis (NCFB). This Phase 2a study is designed as a randomized, double-blind, placebo-controlled trial to measure how the treatment affects mucus plug scores after 24 weeks. The goal is to assess the activity, safety, and tolerability of SAR445399 in this population. Participants receive either SAR445399 or a placebo, both given as injections in a solution form. The study lasts for 24 weeks during which the mucus plug score is monitored using chest high-resolution computerized tomography (HRCT). This imaging helps evaluate the changes in mucus plugs in the lungs from the beginning of the study through Week 24. Throughout the study, participants will undergo chest HRCT scans to measure mucus plug scores and have clinical assessments related to their respiratory health. Researchers will track safety, tolerability, and the treatment's effects on lung function and symptoms. The total participation time includes the 24-week treatment period with ongoing monitoring and evaluation.

Researchers are evaluating treatments for children and young adults with newly diagnosed acute myeloid leukemia (AML), with or without FLT3 gene mutations. This phase III trial compares standard chemotherapy using daunorubicin, cytarabine, and gemtuzumab ozogamicin to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or the FLT3 inhibitor gilteritinib. The study aims to find out which treatment improves event-free survival, overall survival, and minimal residual disease rates, while also monitoring heart function and other effects during and after therapy. Participants are assigned to different treatment arms based on their AML risk group and FLT3 mutation status. Treatments include combinations of intravenous and intrathecal chemotherapy drugs such as cytarabine, daunorubicin, gemtuzumab ozogamicin, dexrazoxane, etoposide, mitoxantrone, asparaginase, and methotrexate. Gilteritinib is given orally to patients with FLT3 mutations alongside chemotherapy. Treatment phases include multiple induction cycles, intensification cycles, and for some, allogeneic stem cell transplantation followed by maintenance therapy with gilteritinib. Throughout the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans like MRI and CT, cardiac function monitoring, and neuropsychological testing. Researchers track event-free survival up to 3 years, changes in heart function, leukemia response, and neurocognitive effects. Optional cognitive tests are offered at several time points. The study also collects blood samples for pharmacokinetic and biomarker analyses to better understand treatment effects and safety.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the effects and safety of the study medicine PF-07275315 for treating moderate to severe chronic obstructive pulmonary disease (COPD), a condition that makes breathing difficult and lowers quality of life. This clinical trial includes adults aged 35 to 80 years who have had COPD for at least 12 months and a history of at least two moderate or severe COPD flare-ups in the past year. The study has two phases: Phase 2 and Phase 3, each designed to assess different outcomes related to lung function and lung flare-ups over time. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections (shots under the skin) at the clinic. The Phase 2 part lasts 24 weeks with 11 clinic visits and focuses on the change in lung function measured by forced expiratory volume in 1 second (FEV1). The Phase 3 part lasts 52 weeks with 18 clinic visits and evaluates the annual rate of moderate or severe COPD flare-ups. Both study phases compare the effects of PF-07275315 to the placebo to assess safety and effectiveness. During the study, participants will visit the clinic regularly for assessments including lung function tests and health evaluations. They will continue their usual COPD maintenance treatments throughout the trial. Researchers will monitor lung function changes and the frequency of COPD exacerbations as primary outcome measures. Participants remain in the study for about 40 weeks in Phase 2 or about 68 weeks in Phase 3, including follow-up visits to ensure safety and collect health information.

Researchers are evaluating whether eptinezumab can reduce the number of migraine days in young people aged 12 to 17 who have chronic migraine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to compare eptinezumab with a placebo in preventing chronic migraine in adolescents. Participants must have a history of chronic migraine for at least six months as defined by recognized headache disorder guidelines. Participants will receive a single intravenous infusion of either eptinezumab at doses of 100 mg or 300 mg, adjusted by body weight to match adult exposure, or a placebo solution. The study includes a 4-week screening period, followed by a 12-week double-blind treatment period, and then an 8-week safety follow-up. Participants are randomly assigned in a 1:1:1 ratio to one of the three groups. Throughout the study, participants will complete headache diaries to record migraine frequency and characteristics. Researchers will measure the change from baseline in monthly migraine days averaged over the first 12 weeks of treatment to assess efficacy. Safety monitoring continues through the follow-up period, with the total participation lasting approximately 24 weeks from screening through follow-up.

Researchers are assessing the long-term safety of eptinezumab in children and adolescents aged 6 to 17 who have chronic or episodic migraine. This Phase 3 extension study invites participants who completed prior migraine studies (19356A or 19357A) to continue treatment and monitoring. The study focuses on understanding how safe eptinezumab is when used over an extended period in this young population. Participants who completed the initial 12-week lead-in studies will join this open-label extension study. Those who previously received 100 mg or 300 mg doses of eptinezumab will continue with the same weight-adjusted dose. Participants who had placebo will be randomly assigned to receive either 100 mg or 300 mg of eptinezumab, also adjusted for weight. The medication is given as a concentrate for solution for infusion. During the study, researchers will monitor participants from baseline through week 44 to track any treatment-emergent adverse events. Safety assessments will guide ongoing participation, with particular attention to any serious reactions or liver-related test abnormalities encountered in the preceding studies. This extended observation aims to provide comprehensive safety data on eptinezumab use in young patients with migraine.

Researchers are evaluating depemokimab as a potential add-on treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in improving health outcomes for people whose COPD is not well controlled despite standard inhaler therapy. Participants must have a history of elevated blood eosinophil levels and confirmed lung function measurements consistent with COPD. Participants will be randomly assigned to receive either depemokimab, given as a sterile liquid, or a placebo solution containing sodium chloride. Both treatments will be administered as part of a double-blind, placebo-controlled trial across multiple centers. The study includes patients who have been on optimized inhaler treatments including inhaled corticosteroids combined with long-acting bronchodilators for at least six months before the study begins. During the study, participants will be monitored over a period extending up to 104 weeks to measure the annualized rate of moderate to severe COPD exacerbations. Researchers will conduct regular assessments including lung function tests, symptom questionnaires, and safety evaluations. The study will also track participants' adherence to treatment and record any side effects or health changes to better understand the long-term impact of depemokimab.