Brookvale

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Researchers are evaluating ways to improve hepatitis C virus HCV care in drug treatment clinics and needle and syringe programs in New South Wales and across Australia. The ETHOS II Project aims to develop a framework to establish HCV screening and treatment programs in these settings nationally. This collaborative research involves several health organizations and focuses on people with a history of injecting drug use or those receiving opioid substitution therapy. The study includes an intervention called campaign days where participants receive hepatitis C screening, liver fibrosis assessments using fibroscans, and clinical assessments. Participants also complete surveys and may consent to link their data with population databases. A sub-study involves collecting blood samples from some participants to evaluate new diagnostic tests for chronic HCV infection. Additionally, interviews with policymakers, clinicians, and patients will explore barriers to HCV care, and an education program will be developed to improve workforce knowledge and care quality. Participants will be recruited from drug treatment clinics, general practitioners with high case loads, and needle and syringe programs. They will undergo hepatitis C testing, fibroscans, clinical assessments, and complete questionnaires during the campaign days. Researchers will track how many participants start anti-HCV treatment each year for up to three years. The study also includes follow-up through medical record reviews to monitor outcomes and improve treatment access and delivery.

Researchers are evaluating the effectiveness of zabalafin hydrogel in people aged 2 years and older who have mild to moderate atopic dermatitis, also known as eczema. This Phase 2b randomized, double-blind study includes two groups one with mild to moderate atopic dermatitis and another with the same condition plus a secondary skin infection. The study aims to compare zabalafin hydrogel to a placebo vehicle to understand its impact on eczema symptoms using a validated global assessment scale. Participants will be randomly assigned in a 21 ratio to receive either zabalafin 9.5% hydrogel or a placebo gel. The study treatment lasts 16 weeks following up to 2 weeks of screening. During treatment, participants will visit the clinic every 2 weeks for the first month and then monthly until the end of the study. The study evaluates not only the effectiveness but also the safety and tolerability of zabalafin compared to the placebo. Throughout the study, participants will undergo assessments including the validated Investigators Global Assessment, Eczema Area and Severity Index, pruritus itching rating, and patient-reported eczema measures. Safety monitoring and evaluation of antibacterial effects in those with skin infections are included. Participants must comply with study procedures, avoid using other topical products on the eczema lesions, and attend scheduled visits over the approximately 16-week treatment period.

Researchers are evaluating the safety and effectiveness of ABP-745 in people experiencing an acute gout flare. This Phase 2, randomized, double-blind, international, multicenter study compares ABP-745 to standard colchicine treatment and placebo. The goal is to see how well ABP-745 reduces pain and swelling during a gout flare, with the main measure being the pain score after treatment. Participants will be randomly assigned to one of four groups two different doses of ABP-745 with a colchicine placebo, standard colchicine treatment with an ABP-745 placebo, or a placebo for both drugs. All treatments are given as tablets by mouth. The study will monitor participants from the first dose through up to 14 days to assess pain changes and any side effects. During the study, participants will have their pain measured using a visual analog scale at various times, including 24 hours and up to 8 days after the first dose. Researchers will also track any treatment-related adverse events for up to two weeks. Participants must maintain stable lifestyle habits and medication doses during the study. The total study duration and follow-up include safety assessments to understand the effects and tolerability of the treatments.

Researchers are evaluating the drug Efsubaglutide Alfa in adults aged 18 to 75 who are overweight or obese. This phase 2, multicenter, double-blind, randomized, placebo-controlled study aims to assess the drugs effectiveness, safety, how the body processes it, and immune response in people with a body mass index BMI between 27 and 30 with at least one related health condition or a BMI of 30 or above with or without other health issues. The study includes a 2-week screening period, a 22-week treatment phase, and a 4-week follow-up after treatment ends. Participants will receive Efsubaglutide Alfa or a placebo through weekly injections. The drug dose starts at 1 mg and is increased every two weeks through a series of steps until reaching a target dose that varies by study group, ranging from 20 mg to 80 mg. Some groups receive the highest dose every one or two weeks, and the total treatment lasts for 22 weeks. The study compares multiple dosing schedules to evaluate effects across different doses and frequencies. During the trial, participants will attend scheduled visits for weight and body measurements, blood pressure, and blood tests including blood sugar and cholesterol levels. Body composition will be measured using DEXA scans. Safety will be monitored throughout by tracking side effects and mental health using questionnaires. Blood samples will also be collected to measure drug levels and immune response. Overall, the study helps understand how the drug affects body weight and other health markers in people with overweight or obesity over about 28 weeks from screening to follow-up.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.