South Yarra

Researchers are conducting a randomized, double-blind, placebo-controlled study to assess the safety and effectiveness of FB102 in adults with severe to very severe alopecia areata (AA). This condition involves significant hair loss, and the study focuses on patients with at least 50% scalp hair loss, including those with total scalp or complete body hair loss. The trial aims to better understand how FB102 may impact hair loss severity compared to placebo in this patient population. Up to about 32 participants will be randomly assigned in a 3:1 ratio to receive either FB102 or a placebo, both given through intravenous (IV) administration. Participants will receive the assigned treatment according to the study plan, with careful monitoring throughout the trial period. The study is designed to maintain blinding so neither participants nor researchers know who receives FB102 or placebo. Participants will be monitored for safety by tracking any treatment-related or serious adverse events up to 36 weeks after the first dose. The main effectiveness measure is the change from baseline in the Severity of Alopecia Tool (SALT) score at week 16, which assesses the extent of hair loss. The study includes screening, treatment, and follow-up assessments to evaluate these outcomes and ensure participant safety over the course of the trial.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the use of cemiplimab, an immune system-boosting drug, to treat early-stage cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Cemiplimab works by attaching to a protein called PD-1 on immune cells, helping them kill cancer cells. This Phase 3 study compares the effectiveness of cemiplimab injected directly into the skin lesion against standard surgical removal of the tumor. The research also examines the side effects that cemiplimab may cause. Participants will either receive cemiplimab injections into the tumor or undergo primary surgery, which involves removing the tumor with precise margin control methods like Mohs surgery. The study focuses on lesions sized between 1 cm and 2 cm located on the head, neck, hand, or pre-tibial area. Those undergoing surgery will have their tumors completely removed with margin assessment to ensure thorough treatment. During the study, investigators will monitor participants for event-free survival (EFS), meaning the length of time without cancer progression or other events, assessed up to one year and up to three years. Researchers will also track side effects and overall treatment response. Participants need to have good general health, adequate liver, kidney, and bone marrow function, and be physically able to undergo surgery if assigned to that group. The study aims to provide important information on how well cemiplimab works compared to surgery for early-stage CSCC.