Hannibal

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 evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Researchers are evaluating the efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

This research focuses on participants who previously took part in Avalyn Pharma-sponsored studies involving inhaled antifibrotic agents, such as AP01, for progressive pulmonary fibrosis or idiopathic pulmonary fibrosis. The study aims to evaluate the long-term safety and tolerability of these inhaled antifibrotic medications, continuing from where the prior study ended. It is an open-label extension study allowing participants to continue treatment with AP01. All participants will receive 100 mg of inhaled pirfenidone solution AP01 twice daily delivered through the eFlow Nebulizer System. The study involves a screening and baseline visit, followed by an open-label treatment period where participants continue receiving AP01. After completing treatment, participants will have a follow-up phone call approximately two weeks later to conclude their involvement. During the study, participants will use a paper dosing diary to track adherence, and any unused medication will be returned for monitoring. Researchers will assess safety and tolerability over an average of six years, along with lung function changes, disease stabilization, and quality of life measures. The total duration extends up to the studys end date in 2031, with ongoing safety evaluations.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in hospitalized adults with severe community-acquired pneumonia sCAP who require invasive mechanical ventilation IMV. This phase III, randomized, placebo-controlled, double-blind study aims to compare trimodulin plus standard care against placebo plus standard care. The study also investigates detailed pharmacokinetic and pharmacodynamic properties of trimodulin. Participants will be randomly assigned to receive either trimodulin a human immunoglobulin solution containing IgM, IgA, and IgG or a placebo human albumin 1% via intravenous infusion once daily for five consecutive days alongside standard care. After treatment, participants will enter a follow-up phase lasting up to 23 days, including an end-of-follow-up visit or phone call on day 29. If still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a closing visit or call around day 91. During the study, participants undergo various assessments including monitoring of mortality rates up to 28 and 90 days, changes in organ failure scores, clinical cure of pneumonia, ventilator and oxygen use, ICU and hospital stay durations, readmission rates, adverse events, lab tests, electrocardiograms, and vital signs. Safety evaluations and outcome measurements occur throughout treatment and follow-up, with total participation lasting up to approximately 90 days.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.

Researchers are evaluating an ECG-based artificial intelligence AI device designed to predict whether patients with interstitial lung disease ILD are at high risk for undiagnosed pulmonary hypertension PH. This multi-center, randomized study aims to determine if using this AI device can increase the rate of new PH diagnoses over a 6-month period compared to the current standard of care. Participants with ILD will undergo a 12-lead ECG, which the AI device will analyze to assess PH risk. Participants are randomly assigned to either the Device group, where investigators receive the AI device results, or the Control group, where results are not shared. Those in the Device group identified as high risk will receive additional tests including a transthoracic echocardiogram and right heart catheterization RHC. Participants not identified as high risk and all Control group participants will continue with standard care as determined by their physicians. Throughout the study, participants will be monitored over approximately 6 months to track new PH diagnoses. Assessments include ECGs, echocardiograms, RHC procedures if indicated, and ongoing clinical evaluations. Researchers will compare the proportion of new PH diagnoses between groups while ensuring participants receive appropriate care based on their risk and physician recommendations.

Researchers are evaluating recombinant human plasma gelsolin rhu-pGSN combined with standard care for adults with moderate-to-severe Acute Respiratory Distress Syndrome ARDS caused by pneumonia or other infections. This Phase 2 study aims to assess the safety and effectiveness of rhu-pGSN in patients who develop acute hypoxemic respiratory failure within seven days of infection and require mechanical or noninvasive ventilation or high-flow oxygen support. Potential participants are screened within 24 hours of ARDS diagnosis to confirm eligibility based on oxygenation levels and infection status. Participants are randomly assigned to receive either rhu-pGSN or a saline placebo alongside standard care. Treatment consists of a single loading dose of 24 mgkg rhu-pGSN followed by five daily doses of 12 mgkg, delivered intravenously through a filter. The study drug or placebo is administered within 48 hours of moderate-to-severe ARDS diagnosis. The study includes detailed assessments such as medical history, imaging, blood tests, cultures, and pregnancy tests when applicable. Safety is monitored by an independent board with periodic reviews. During the study, participants undergo regular evaluations including blood sampling for immune response and biomarker analysis, imaging tests, and cultures as needed. The primary outcome is all-cause mortality at 28 days, with additional assessments of survival, ventilator use, ICU and hospital stay lengths, and adverse events up to 60 days. Follow-up visits occur at 14 and 28 days after discharge, including telephone checks at 60 days. The total participation duration varies depending on individual progress and clinical status.

Idiopathic Pulmonary Fibrosis IPF is a rare, chronic lung disease that causes scarring of lung tissue, leading to shortness of breath, reduced lung function, and decreased quality of life. Researchers are evaluating different treatments for IPF using a platform study design, which allows multiple treatments to be tested under one protocol. This study specifically aims to assess the safety, tolerability, and effectiveness of the investigational drug ABBV-142 compared to placebo in adults with IPF. Participants will be randomly assigned to receive either ABBV-142 or a matching placebo for 52 weeks during a double-blind treatment phase, where neither participants nor doctors know who receives which treatment. After this, eligible participants may receive ABBV-142 for an additional 52 weeks in an open-label phase. The study includes regular visits to clinics or hospitals for treatment and monitoring. During the study, participants will undergo medical assessments, blood tests, and questionnaires to monitor the effects of the treatment and any side effects. Researchers will measure changes in lung function, specifically forced vital capacity FVC, and track adverse events over approximately 52 weeks. All participants will be followed for an additional 120 days after treatment to ensure safety and gather further data. The total participation duration may span over two years, depending on eligibility for the open-label phase.