Brookvale

Researchers are investigating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults with knee osteoarthritis (OA) pain. This Phase 3, randomized, double-blind, placebo-controlled study aims to evaluate changes in knee pain and function. The study will enroll approximately 466 participants who meet specific clinical and radiographic criteria for knee OA and have experienced pain despite prior treatments. Participants will be randomly assigned to receive either PPS at a dose of 2 mg/kg or placebo via subcutaneous injections twice weekly for 6 weeks. The study includes a 7-week screening period, followed by the 6-week treatment phase, and a 52-week follow-up period, totaling up to 64 weeks of participation. An interim analysis will be conducted after about half of the participants complete Day 112, with final analysis after all complete Day 404. Throughout the study, participants will attend visits twice weekly during treatment and every 4 to 6 weeks during follow-up. Researchers will assess knee pain using a daily pain rating scale and monitor changes from baseline up to Day 112. Safety and treatment effects will be evaluated through clinical exams, laboratory tests, and imaging as needed. Participants must adhere to stable non-pharmacologic treatments and limit use of certain medications during the trial.

Researchers are working on the ETHOS II Project to improve care for people with hepatitis C virus (HCV) in drug treatment clinics and needle and syringe programs (NSPs) across New South Wales and Australia. The project aims to create a framework for better HCV screening and treatment services in these settings nationally. It is a collaborative effort involving multiple health and research organizations, focusing on individuals with a history of injecting drug use or those receiving opioid substitution therapy. The study involves an intervention that includes on-site HCV RNA testing, liver fibrosis assessment, and helping participants connect to care to increase the use of direct-acting antiviral therapy for HCV. Participants will undergo procedures such as Hepatitis C testing, fibroscan, questionnaires, and clinical assessments during "campaign days." A sub-study will invite 550 participants to provide blood samples to evaluate new diagnostic tests for chronic HCV infection. The project also includes interviews with policy makers, clinicians, and patients to understand challenges in HCV care, and the development of an education and training program to improve workforce skills and HCV care quality. Participants will be recruited from drug treatment clinics, general practices, and NSP programs. They will complete surveys and may consent to link their data with health databases for ongoing study. The main outcome measured is the number of participants starting anti-HCV treatment each year for up to three years. Researchers will monitor participant health records and follow up through medical record reviews, ensuring thorough tracking of treatment initiation and care engagement throughout the study duration.

Researchers are evaluating the safety and effectiveness of a topical gel called zabalafin for treating people with mild to moderate atopic dermatitis, also known as eczema. This Phase 2b study includes two groups: one with mild to moderate atopic dermatitis and another group with mild to moderate atopic dermatitis plus a secondary skin infection. The goal is to compare zabalafin hydrogel against a placebo (vehicle) over a 16-week treatment period. Participants will be randomly assigned to receive either zabalafin hydrogel or a placebo in a 2:1 ratio. The study includes up to 72 participants across 10 sites in Australia. After up to 2 weeks of screening, participants will apply the assigned gel and visit the study site every 2 weeks for the first month, then monthly until the 16-week treatment ends. This double-blind study means neither participants nor researchers know who receives which treatment. During the study, participants will undergo regular evaluations including a clinical assessment using the validated Investigator's Global Assessment scale (vIGA) to measure treatment effects. Researchers will monitor the severity of eczema, skin lesion size, itching intensity, and any side effects. Participants must follow study procedures, including avoiding other topical products on affected skin areas and attending scheduled visits for up to 113 days.

Researchers are conducting a Phase 2, randomized, double-blind, international multicenter study to assess the safety and effectiveness of ABP-745 in adults experiencing acute gout flares. The study compares ABP-745 with standard colchicine treatment and placebo to evaluate their impact on reducing pain and swelling. The main focus is to measure pain relief after treatment using a visual analog scale. Participants are assigned to one of four groups receiving either two different doses of ABP-745 with colchicine placebo, colchicine with ABP-745 placebo, or double placebo tablets. Treatments are given orally. The study monitors pain changes 24 hours after the first dose. The trial includes adults aged 18 to 70 with a history of gout flares and evaluates responses shortly after flare onset. During the study, participants will undergo assessments including pain scoring to track changes in joint pain. Researchers will monitor safety and treatment effects throughout the treatment period. The total participation timeline includes screening and treatment phases, with attention to medication stability and lifestyle consistency. Pain score changes 24 hours post-treatment serve as the primary outcome measure for evaluating treatment efficacy.

Researchers are conducting a Phase 1/2 randomized, observer-blinded, dose-escalation trial to evaluate the safety, tolerability, and immune response of an investigational herpes zoster vaccine called Z-1018 compared to the approved Shingrix vaccine. The study involves healthy adults aged 50 years and older, aiming to better understand how these vaccines perform in preventing shingles and related complications. In Part 1 of the trial, about 440 participants aged 50 to 69 years will be randomly assigned to one of ten groups receiving different doses of Z-1018 or to the Shingrix group. Part 2 will enroll approximately 324 participants aged 70 years or older to receive either the selected Z-1018 dose from Part 1 or Shingrix in a 1:1 ratio. Participants receive two vaccine doses, and Part 2 includes extended follow-up for four years after the initial 12-month post-vaccination period to assess long-term immune protection and incidence of shingles and postherpetic neuralgia. Participants will be monitored for local and systemic reactions up to seven days after each dose and adverse events for 28 days post-injection. Serious and medically attended adverse events will be tracked for up to 12 months after the last dose. Immune responses will be measured four weeks after the second dose by vaccine response and antibody levels. Study visits include medical evaluations, laboratory tests, and adherence assessments throughout the trial duration.

Researchers are evaluating the effects of Efsubaglutide Alfa, an investigational drug, in adults who are overweight or obese. This phase II trial aims to assess its safety, effectiveness, how the body processes the drug, and immune responses. Participants include those with a body mass index (BMI) between 27 and 30 kg/m2 with at least one related health condition, or those with a BMI of 30 kg/m2 or higher regardless of other conditions. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial to provide reliable results. Participants will receive different doses and schedules of Efsubaglutide Alfa or a placebo during a 22-week treatment period. The doses include 20 mg weekly, 40 mg weekly or every two weeks, and 80 mg weekly or every four weeks. The study starts with a 2-week screening period to determine eligibility, followed by the 22-week double-blind treatment phase where neither participants nor researchers know who receives the drug or placebo. After treatment, there is a 4-week follow-up period without medication to monitor participants. Throughout the study, participants will have regular visits and assessments to monitor changes in body weight from the start of treatment. Researchers will also evaluate safety and drug effects through physical exams, laboratory tests, and tracking of any side effects. The total study time for participants is approximately 28 weeks, including screening, treatment, and follow-up. The main goal is to measure the percentage change in body weight after 22 weeks of treatment with Efsubaglutide Alfa.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.