Horseheads

Researchers are studying the safety and effectiveness of lebrikizumab in adults with perennial allergic rhinitis, a condition involving year-round nasal allergy symptoms. This phase 3 clinical trial aims to assess how well lebrikizumab works when given alongside standard intranasal corticosteroid therapy. The study is sponsored by Eli Lilly and Company and lasts up to 29.5 months for each participant. Participants will receive lebrikizumab or a matching placebo through subcutaneous injections on different schedules, either every 2 weeks, every 4 weeks, or every 8 weeks, combined with ongoing intranasal corticosteroid use. The trial includes multiple treatment groups with random assignment and double-blind masking to compare the effects of lebrikizumab against placebo while all participants continue their background nasal spray therapy. During the study, participants will have their nasal symptoms evaluated at baseline and at various points, including week 16 and week 56, using symptom scores and quality of life questionnaires. Researchers will monitor changes in nasal symptoms, quality of life, and postnasal drip. Safety and any adverse effects will also be tracked throughout the study duration, with follow-up visits and assessments as scheduled.

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease (COPD) to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

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). This Phase 3 study includes participants who have had at least two moderate or one severe COPD exacerbations in the past year despite inhaled maintenance therapy. The goal is to better understand if tezepelumab can reduce the rate of COPD exacerbations and improve lung function and quality of life. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo for a treatment period lasting between 52 and 76 weeks. After the treatment phase, there is a 12-week off-treatment safety follow-up. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives the active medication or placebo. During the study, participants will have regular assessments including lung function tests, questionnaires about respiratory health and symptoms, and blood samples to measure drug levels and immune response. Researchers will track COPD exacerbation frequency, lung function changes, and symptom improvements. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods, with total participation lasting up to approximately 88 weeks.

Researchers are studying the safety and immune response of a fifth dose of the Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older who have already received four doses of this vaccine. This Phase 3 trial compares the effects of the vaccine against a placebo (saline) to better understand its protection against Lyme disease. The study is randomized, placebo-controlled, and double-blinded, aiming to assess tolerability and immune response. Participants receive one injection, either VLA15 or saline, into the muscle of the upper arm at their first visit. They are randomized in a 5:1 ratio to either vaccine or placebo. The timing of the fifth dose varies, occurring either one or two years after the fourth dose from a previous study. The trial includes about 1712 participants and uses an independent data monitoring committee to oversee safety. During approximately 12 months of participation, individuals will attend four clinic visits. These visits include health checks, blood draws to measure immune response, and receiving the study injection during the first visit. Researchers will monitor local and systemic reactions within seven days post-injection, adverse events up to one month, and longer-term safety for up to a year. The main outcomes focus on immune responses to different parts of the vaccine and recording any side effects or new medical conditions.