Canberra

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone (called AP01) compared to a placebo in people with progressive pulmonary fibrosis (PPF). This Phase 2b study is randomized, double-blind, and placebo-controlled, involving up to 300 participants who will continue their standard care during the 52-week trial. The goal is to see how well AP01 works and how safe it is when added to usual treatments for PPF. Participants will be randomly assigned to one of three groups: high-dose AP01, low-dose AP01, or placebo. All treatments are given as an oral inhalation solution twice daily. The study will last for 52 weeks, during which researchers will monitor and compare the effects of these treatments on lung function and disease progression. During the study, participants will undergo various assessments including lung function tests and clinical evaluations to track their respiratory health. Researchers will check for changes in lung capacity and symptoms and monitor safety throughout the treatment period. The main outcome measured is the impact of AP01 doses compared to placebo after 52 weeks of treatment.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the effectiveness and safety of standard chemotherapy alone or combined with INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma (PDAC) with a KRAS G12D mutation. This phase 3, randomized, double-blind study focuses on individuals who have not received prior treatment for metastatic PDAC. The goal is to understand if adding INCB161734 to chemotherapy improves outcomes in this group of patients. Participants will receive either oral INCB161734 tablets or a placebo, along with a chemotherapy regimen selected by the investigator following specific protocol requirements. The chemotherapy options are defined by the study protocol. Treatments will be administered as planned during the study period, with careful monitoring to assess their effects. Throughout the study, participants will be monitored for overall survival up to approximately three years, progression-free survival, and objective tumor response assessed up to about two years. Researchers will conduct regular evaluations including clinical assessments and imaging reviewed by blinded independent central review (BICR). Safety and efficacy data will be collected to understand the impact of the treatments over time.

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Researchers are evaluating an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplantation. The study focuses on comparing the effects and safety of linvoseltamab against the standard treatment in this group of patients. This is a Phase 3 randomized, open-label study involving transplant-ineligible multiple myeloma patients. Participants will receive either linvoseltamab according to the study protocol or a combination of daratumumab, lenalidomide, and dexamethasone as the standard treatment. The trial includes an induction phase with daratumumab, lenalidomide, and dexamethasone followed by treatment with linvoseltamab or continuation of the standard therapy. All drugs are administered as directed by the study protocol. During the study, participants will be closely monitored for disease response and safety over a period of up to 11 years. Researchers will measure outcomes such as minimal residual disease status, progression-free survival based on specific criteria, and treatment response assessed by blinded independent review. Safety and long-term effects will also be evaluated throughout the study duration.

Researchers are evaluating treatments for BK polyomavirus (BKPyV) infection, a serious condition affecting kidney and simultaneous pancreas-kidney transplant recipients. This Phase 3 adaptive randomized controlled trial explores the impact of reducing or modifying immunosuppression therapy, with or without the addition of intravenous immunoglobulin (IVIG), on infection outcomes, allograft health, rejection episodes, immunosuppression burden, and patient survival. Balancing immune suppression to prevent rejection while avoiding infection complications is critical for these patients, and this trial builds on previous observational data suggesting potential benefits of IVIG as an adjunct therapy. Participants will be assigned to one of two groups: one receiving immunosuppression reduction or modification alone, and the other receiving immunosuppression adjustment combined with intravenous immunoglobulin. The immunosuppression changes may include dose reductions of calcineurin inhibitors and antiproliferative agents or switching to less potent drugs like cyclosporine or azathioprine. IVIG, containing natural antibodies, is given to help fight the virus and modulate the immune response. Treatments are administered during the main study period, with the goal of assessing their effects on viral clearance and graft function. During the trial, participants will be closely monitored for a composite outcome including death from any cause, loss of the transplanted organ, decline in kidney function (eGFR), episodes of acute rejection, viral load above a certain threshold, and overall immunosuppression levels over 11 to 13 weeks. Assessments include laboratory tests for viral DNA, kidney function measures, and clinical evaluations to track safety and efficacy. This monitoring helps researchers understand how well the interventions control the infection and protect the transplanted organs while minimizing risks.

Researchers are studying Clonal Haematopoiesis (CH), a condition where a group of blood stem cells grow abnormally without blood cancers. CH is common in older adults and increases the risk of blood cancers, heart disease, and stroke. Most people with CH have no symptoms, but identifying CH early may help create personalized plans to watch for complications. This study aims to establish a dedicated CH clinic and a detailed patient registry in Australia to better understand outcomes and patient experiences. Participants aged 55 and older who have confirmed CH or possible CH based on certain blood count criteria will be invited to join. Those who consent will undergo molecular testing and regular monitoring in the first multidisciplinary CH clinic in Australia. The study includes long-term tracking of health outcomes and supports participants with assessments of risks for heart and blood diseases. Blood samples and health information will be collected for research and CH monitoring. During the study, participants will provide blood samples and health details, which will be recorded in a central database over up to five years. Researchers will assess participants' understanding of CH and emotional responses after diagnosis. The study focuses on monitoring CH progression, cardiovascular risk, and related complications while providing personalized support. This long-term follow-up aims to guide future care and research for people with CH in Australia.

Researchers are evaluating the safety and effectiveness of a drug called HB-1 compared to placebo and two other medications in adults aged 18 to 65 years diagnosed with Panic Disorder. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to include approximately 240 to 600 participants, including those with or without certain co-existing conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to receive HB-1, telmisartan, verapamil, or a matched placebo, all provided as tablets. The treatment period lasts 12 weeks, after which a safety follow-up visit will occur one week after the last dose. Throughout the study, patients and researchers will not know which treatment the participants receive to ensure unbiased results. During the trial, participants will be monitored regularly for the number of unexpected panic attacks and any side effects that may arise, with assessments occurring weekly during treatment and at follow-up. Safety evaluations, including laboratory tests and questionnaires, will be conducted at specific intervals to track participants' health and treatment effects throughout the study duration.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

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.