Puncak Alam

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. The study aims to show that V181 is safe, well tolerated, and reduces the frequency of dengue infections caused by any of the four dengue virus types, regardless of whether the child had previous exposure to dengue before vaccination. This is a phase 3, randomized, double-blind, placebo-controlled trial involving healthy participants within this age range. Participants will be randomly assigned to receive either a single 0.5 mL subcutaneous dose of the V181 vaccine or a placebo on Day 1. A subset of about 3,600 participants will be closely followed for immune response and safety for 28 days after vaccination. From this group, around 620 participants will be randomly selected to have their long-term immune response evaluated at selected times for up to 5 years after vaccination. Throughout the study, children will undergo medical history reviews and physical exams to confirm health status. Safety will be monitored by recording adverse events, including those requiring medical attention up to 6 months post-vaccination and serious events up to 5 years. The study also tracks injection site reactions and systemic side effects shortly after vaccination, and measures vaccine effectiveness by monitoring dengue infection rates up to 3 years after vaccination. Immune response tests will be done at planned intervals to assess how well the vaccine works over time.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the effectiveness of saruparib (AZD5305) combined with camizestrant compared to physician's choice of CDK4/6 inhibitor plus endocrine therapy or plus camizestrant in patients with advanced breast cancer. Participants must have hormone receptor-positive, HER2-negative breast cancer with specific genetic mutations in BRCA1, BRCA2, or PALB2. This is a phase III randomized, open-label study focused on first-line treatment for this patient group. Participants will be randomly assigned in a 2:2:1 ratio to one of three treatment groups: saruparib plus camizestrant; physician's choice of CDK4/6 inhibitor plus physician's choice of endocrine therapy; or physician's choice of CDK4/6 inhibitor plus camizestrant. Treatment continues until disease progression confirmed by blinded independent central review, unacceptable side effects occur, or the participant decides to stop. During the study, about 500 participants will be monitored for progression-free survival for up to approximately 59 months. Researchers will collect tissue samples and assess organ function, performance status, and treatment safety. Participants will be evaluated regularly for disease progression, treatment tolerability, and overall health throughout the study duration.