Hannibal

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 evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout 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 focuses on people with progressive pulmonary fibrosis or idiopathic pulmonary fibrosis (IPF) who have already completed a previous Avalyn Pharma study involving an inhaled antifibrotic medication, such as AP01. The trial aims to evaluate the long-term safety and tolerability of Avalyn's inhaled antifibrotic drug over an average of 6 years. It is an open-label extension study where all participants continue receiving treatment after their initial study completion. Participants will receive 100 mg of pirfenidone inhalation solution (AP01) twice daily through the eFlow Nebulizer System. The study includes a Screening/Baseline Visit, an open-label Treatment Period where the study drug is administered, and a Follow-up/End of Study phone call about two weeks after the last dose. Participants will start this extension on the same day they complete their previous study's final dose. During the study, adherence will be tracked using a paper dosing diary and by collecting any unused medication. Assessments include safety and tolerability monitoring throughout the long-term treatment period. The total participation lasts through the end of the study, with follow-up calls to evaluate ongoing safety after treatment ends.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in adults hospitalized with severe community-acquired pneumonia (sCAP) who require invasive mechanical ventilation. This phase III, randomized, placebo-controlled, double-blind, multi-center trial aims to compare trimodulin plus standard care against placebo plus standard care. The study also includes substudies to understand the pharmacokinetics and pharmacodynamics of trimodulin. Participants will be randomly assigned to receive either trimodulin or placebo via intravenous infusion once daily for five consecutive days alongside standard care. After the treatment phase, patients will be followed for up to 23 days, with an end-of-follow-up visit or telephone call on day 29. For those still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a final visit or call on day 91. During the study, participants will undergo various assessments including monitoring of mortality rates up to day 29, clinical evaluations, and safety monitoring. Researchers will collect data on inflammation markers and other health parameters. Follow-up contacts and visits will ensure ongoing evaluation of patient status and adverse events throughout the study period, which may last up to 91 days or longer depending on hospital discharge timing.

Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.

Researchers are investigating the use of an ECG-based artificial intelligence (AI) device to predict the risk of undiagnosed pulmonary hypertension (PH) in people with interstitial lung disease (ILD). This multi-center, randomized study aims to see if using this device increases the number of new PH diagnoses over about 6 months compared to standard care. The study involves adult participants who have a known diagnosis of ILD and a specific lung function measurement (DLCO) below 30% predicted. Participants will be randomly divided into two groups: the Device group and the Control group. Both groups will have a 12-lead ECG test analyzed by the AI device, but only investigators in the Device group will receive the AI results. Those in the Device group identified as high risk for PH will undergo further tests including an echocardiogram (heart ultrasound) and right heart catheterization (RHC, a procedure measuring heart pressures). Participants not high risk and those in the Control group will receive usual care determined by their doctors. Throughout the study, participants will be monitored for new diagnoses of PH over approximately six months. Researchers will assess how many participants in each group receive a new PH diagnosis as the primary outcome. Safety and treatment decisions will continue under standard medical care. The study requires participants to complete all study procedures, including additional tests if indicated by the AI device results.

Researchers are evaluating the use of recombinant human plasma gelsolin (rhu-pGSN) combined with standard care in adults with moderate-to-severe acute respiratory distress syndrome (ARDS) caused by pneumonia or other infections. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of rhu-pGSN in patients who develop acute hypoxemic respiratory failure within a week of infection. Participants are screened within 24 hours of ARDS diagnosis, defined by a P/F ratio of 150 or less, and require mechanical ventilation, noninvasive ventilation, or high-flow oxygen support. Participants who qualify are randomly assigned to receive either rhu-pGSN or a placebo. The treatment group receives one loading dose of 24 mg/kg rhu-pGSN followed by five daily doses of 12 mg/kg, given intravenously based on actual body weight. Study drug administration begins within 48 hours after ARDS diagnosis. The placebo group receives an equal volume of sterile saline. Treatment is given through an IV push with specific equipment to ensure proper delivery. Throughout the study, participants undergo multiple assessments including medical history, infection site identification, pregnancy tests for women of childbearing potential, blood sampling for biomarkers and antibodies, chest X-rays or CT scans, cultures, and routine lab tests. Safety is monitored by an independent board that reviews data periodically to detect any risks. The main outcome measured is all-cause mortality at 28 days, with additional follow-ups on days 7, 14, and 60. The study includes continued monitoring and data collection during hospitalization and after discharge, lasting at least 28 days post-treatment.