Cortland

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will 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 up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the safety, tolerability, and immune response of a fifth dose of the 6-valent OspA-based Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older. This Phase 3, randomized, placebo-controlled, double-blinded study aims to understand the effects of an additional vaccine dose on protection against Lyme disease and to monitor for any adverse reactions or new medical conditions. Participants will be randomly assigned in a 5:1 ratio to receive either one dose of VLA15 or a saline placebo injection in the upper arm during the first clinic visit. The study involves about 1712 participants who have previously received four doses of VLA15 and had blood samples taken after the fourth dose. The total study duration is approximately 12 months, during which participants will attend four scheduled clinic visits. Throughout the study, participants will undergo health checks and provide small blood samples. Researchers will monitor for local and systemic reactions within 7 days after vaccination, adverse events up to one month post-vaccination, and any serious adverse events or newly diagnosed chronic medical conditions through the entire study period. Immune responses to the vaccine will be measured one month after the fifth dose. Safety will be overseen by an independent data monitoring committee.

Researchers are evaluating the drug dupilumab in people with asthma that is not well controlled despite current treatment. Asthma is a condition where the airways are narrow and swollen, making breathing difficult. This study aims to compare adding dupilumab to a medium dose inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) versus increasing the ICS/LABA dose to a higher level. Some patients may also continue using a long-acting muscarinic antagonist (LAMA) if they are already taking it. Participants will receive either dupilumab or a matching placebo by subcutaneous injection, alongside their inhaled asthma medications given in blinded doses. The study will monitor patients over a period of 52 weeks to compare the effectiveness of the treatment regimens. This is a phase 3b clinical trial conducted in Canada, and minors will not be enrolled in Denmark. Throughout the study, participants will be assessed for asthma symptoms and lung function, including measuring the rate of severe asthma flare-ups. Researchers will track side effects and monitor adherence to treatment. Participants will undergo lung function tests and complete questionnaires to evaluate asthma control. The goal is to understand how well dupilumab works in combination with standard inhaled therapies over one year.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.