Leesburg

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 safety and effectiveness of two doses of inhaled pirfenidone (called AP01) compared to a placebo in people with progressive pulmonary fibrosis (PPF). This Phase 2b study is randomized, double-blind, and placebo-controlled, involving up to 300 participants who will continue their standard care during the 52-week trial. The goal is to see how well AP01 works and how safe it is when added to usual treatments for PPF. Participants will be randomly assigned to one of three groups: high-dose AP01, low-dose AP01, or placebo. All treatments are given as an oral inhalation solution twice daily. The study will last for 52 weeks, during which researchers will monitor and compare the effects of these treatments on lung function and disease progression. During the study, participants will undergo various assessments including lung function tests and clinical evaluations to track their respiratory health. Researchers will check for changes in lung capacity and symptoms and monitor safety throughout the treatment period. The main outcome measured is the impact of AP01 doses compared to placebo after 52 weeks of treatment.

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 conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are evaluating the effectiveness and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma who are already using medium-dose inhaled corticosteroids combined with long-acting beta2-agonists (ICS-LABA). The study compares this approach to the usual care of increasing inhaled therapy to high-dose ICS-LABA. This is a global, phase 3b, randomized, double-blind, active-controlled trial involving participants with a history of eosinophilic asthma. Participants receive either benralizumab 30 mg by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks, alongside their medium-dose ICS-LABA treatment, or they receive a placebo injection with an increased high-dose ICS-LABA treatment. The study includes a run-in period to monitor compliance with usual asthma treatment and aims to assess adding benralizumab versus stepping up inhaled therapy. During the study, researchers monitor asthma control, lung function, and exacerbations over 48 weeks. Participants complete asthma diaries to track medication adherence and symptoms. The main outcome measured is the annual rate of asthma exacerbations. Safety and adverse events are also closely followed throughout the study period.

Researchers are evaluating the effects of Taplucainium Inhalation Powder (NOC-110) in adults aged 18 to 80 who have refractory or unexplained chronic cough lasting at least 12 months. This phase 2b study aims to assess the medicine's efficacy, safety, and tolerability compared to a placebo in a randomized, double-blind, controlled setting. The study will involve about 455 participants, with up to 1264 screened to identify eligible adults. Participants will receive either NOC-110 inhalation powder or a matching placebo once daily during the treatment period. The study includes a screening phase followed by approximately 13 weeks of participation, during which participants will use the assigned inhalation powder. The trial is designed to monitor how the treatments impact cough frequency and overall tolerability over this period. Throughout the study, participants will be closely monitored for changes in their 24-hour cough rates, measured from baseline to the end of treatment. Researchers will also assess safety and any side effects. Participants will provide informed consent and follow contraceptive guidance if applicable. The study includes detailed tracking of medical history, respiratory health, and other relevant factors to ensure participant safety and gather comprehensive data on treatment effects.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.