Allen Park

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

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 conducting a phase 3 randomized, modified double-blind study to evaluate three lots of the investigational 21-valent pneumococcal conjugate vaccine (PCV21) in healthy infants aged approximately 2 months. The study aims to compare the immune response, measured by antibody production, and safety of PCV21 to a licensed 20-valent pneumococcal vaccine (Prevnar 201). The goal is to confirm if the different lots of PCV21 produce a similar immune response and assess their safety in infants. Participants will receive four doses of either PCV21 or the licensed 20vPCV vaccine by intramuscular injection at around 2, 4, 6, and 12 months of age. The study includes two groups: Cohort A, which randomizes infants to three PCV21 groups or one 20vPCV comparator group, and Cohort B, which includes randomization to three PCV21 groups only. Routine pediatric vaccinations will also be given according to local recommendations. The study involves six visits over approximately 17 months, spaced between vaccination times and follow-up assessments. Researchers will collect blood samples to measure specific antibody levels 30 days after the third vaccine dose. Participant health will be monitored through medical evaluations and questionnaires. The study will assess vaccine safety and immune response consistency across the vaccine lots during this period.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.