Launceston

Researchers are evaluating LTI-03, an experimental inhaled medication, for the treatment of Idiopathic Pulmonary Fibrosis IPF, a progressive and fatal lung disease characterized by lung cell death and scarring that worsens breathing over time. This Phase 2 study aims to assess LTI-03s safety, side effects, impact on lung scarring, and symptom improvement compared to placebo in patients diagnosed within the last five years. Participants may be on stable doses of other approved IPF treatments like nintedanib, pirfenidone, or nerandomilast. Participants will be randomly assigned to receive either LTI-03 or a placebo, both delivered via inhaler capsules. The study includes a 28-day screening period, followed by a 24-week treatment phase, and a 4-week follow-up. About 120 participants will self-administer the study drug twice daily. Assessments include lung function tests, lung scans, blood samples for biomarkers, and symptom questionnaires. Participants will visit the clinic up to nine times during the study for safety checks including physical exams, vital signs, heart monitoring, and blood tests. Lung function will be tested regularly, and specialized lung scans will be done at baseline and end of treatment to measure fibrosis changes. Researchers will monitor adverse events and study drug use throughout. The main outcome is safety and tolerability measured by treatment-related side effects during the 24 weeks of treatment.

Researchers are evaluating an investigational eye drop called CA201A, which contains 5% ascorbic acid, to see if it can protect the cornea and reduce the loss of corneal endothelial cells following cataract surgery. This study involves about 200 adults in Australia who are scheduled for cataract surgery and aims to assess the safety and effectiveness of the eye drops in preserving corneal clarity and eye health. Participants will be randomly assigned to receive either the CA201A eye drops or a placebo eye drop without the active ingredient. They will apply one drop to the study eye four times daily starting 7 days before surgery, continuing on the day of surgery, and for 4 weeks after surgery. All participants will undergo standard cataract surgery with usual care, and the study eye drops are given in addition to this routine treatment. During the study, participants will have regular eye examinations including measurements of corneal endothelial cell density and other assessments to monitor the treatments effects and safety. Follow-up will continue for up to 12 weeks after surgery, with total participation lasting about 16 weeks including screening. Researchers will evaluate changes in corneal cells and visual acuity, as well as monitor for any side effects throughout the study.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating TO-O-1007, a biodegradable sustained-release intravitreal implant, for the treatment of Geographic Atrophy GA caused by Age-related Macular Degeneration AMD. The study is designed to assess the safety, tolerability, pharmacokinetics, and early effectiveness of this implant. TO-O-1007 aims to provide a long-lasting treatment option that may slow the progression of GA lesions and reduce the need for frequent eye injections. Participants will receive one of several treatments a low-dose or high-dose TO-O-1007 implant injected into the eye, or a sham injection to maintain masking. The implant gradually degrades, releasing medication over approximately six months. This study includes two phases Phase I and Phase IIa with different dosing groups to evaluate the implants effects and safety compared to a sham treatment. During the study, participants will undergo eye exams to monitor lesion growth and visual function at multiple time points, including baseline, 12 weeks, and 24 weeks. Safety will be closely watched through treatment-emergent adverse event recording up to six months. Pharmacokinetic sampling will be done at several intervals to measure drug exposure. The total study duration extends up to 28 weeks with regular visits for assessments and monitoring of the implants effects on vision and eye health.

Researchers are conducting a three-part Phase 3 clinical trial to evaluate a potential new medicine called Sofetabart Mipitecan Sofe-M in people with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancers. The study focuses on patients with platinum-resistant cancer in Part A, meaning their disease worsened during or within six months of platinum-based chemotherapy, and platinum-sensitive cancer in Parts B and C, where disease remained controlled for more than six months after platinum treatment. The goal is to assess whether Sofe-M works better than current standard treatments and to understand its safety. Participants receive treatments administered intravenously. Part A compares Sofe-M to investigators choice of chemotherapy or Mirvetuximab Soravtansine MIRV. Parts B and C compare Sofe-M plus bevacizumab to platinum-based doublet chemotherapy plus bevacizumab. The study includes multiple chemotherapy options such as paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Each participants involvement duration depends on their response to treatment. During the trial, participants undergo regular assessments including imaging to measure progression-free survival and overall survival. Researchers also track tumor marker responses, side effects, quality of life scores, and pharmacokinetics of Sofe-M. The study uses a randomized design without masking. Follow-up can last up to about 70 months, allowing for long-term safety and effectiveness monitoring.

Researchers are evaluating linvoseltamab, an experimental drug also called REGN5458, in adults with multiple myeloma that has returned or needs treatment again after one to four prior therapies. The study compares linvoseltamab to a combination of three cancer drugs elotuzumab, pomalidomide, and dexamethasone EPd. This phase 3 study aims to assess the safety and effectiveness of linvoseltamab versus EPd in participants who have standard treatment options available and have previously received certain therapies including lenalidomide and a proteasome inhibitor. Participants are randomly assigned to one of two groups one receiving linvoseltamab by intravenous infusion, and the other receiving the EPd combination, with elotuzumab given by infusion and pomalidomide and dexamethasone given by mouth or infusion. The study focuses on how long participants benefit from the treatments, the degree of tumor response, side effects, survival, and pain improvement. During the study, participants will undergo regular assessments including disease response evaluations based on established criteria, safety monitoring, and patient-reported outcomes like pain and quality of life questionnaires. The primary measure is progression-free survival over up to about five years. Researchers will also track overall survival, adverse events, antibody responses, and other health status measures. Participation involves treatment, follow-up visits, and ongoing monitoring to understand the treatments impact.

The trial studies adults preparing for lung or major abdominal cancer surgery to evaluate the impact of an online education program delivered via telehealth. It compares this program with usual care to see if it reduces respiratory complications after surgery. The study also looks at secondary outcomes like hospital stay length, recovery, physical function, symptoms, quality of life, and survival. Participants receive either a one-time online group education session called Surgery School, featuring video presentations and a live clinician facilitator. Those awaiting lung cancer surgery in the intervention group may be randomly assigned to also receive an individualized inspiratory muscle training and walking program delivered by a physiotherapist via telehealth before surgery. The control group continues with usual care, which may include advice on smoking cessation, nutrition, and medical optimization. Throughout the study, participants are monitored for postoperative pulmonary complications daily up to 7 days or discharge. Various assessments include symptom questionnaires, physical activity measures, self-efficacy, behavior change, and quality of life surveys at baseline, preoperative, and postoperative timepoints. The study tracks attendance, video access, and participant satisfaction. Follow-up visits assess health service use and outcomes up to 12 months after surgery, with some data collected for up to 3 years.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are investigating the best treatment approaches for infections in artificial hip and knee joints. This study compares different surgical methods, antibiotic choices, and durations of antibiotic treatment to determine which combinations lead to the best outcomes and cure rates at 12 months. The trial focuses on adults with infected artificial joints and aims to address the significant health and economic impacts of prosthetic joint infections. Participants may receive one of several surgical strategies cleaning the infected joint without removing the implant DAIR, or revision surgery where the infected implant is replaced either in a single operation or two stages. Antibiotic treatments are also compared, with some participants receiving standard antibiotics alone and others receiving additional rifampicin. The study further explores different lengths of antibiotic courses after revision surgery, including shorter and longer durations and extended prophylaxis after two-stage revisions. During the study, participants consent to have their medical and treatment information collected in a central database and registry. Researchers will assess health status, infection cure, joint function, quality of life, and antibiotic use at 100 days and 12 months after starting the study. Outcomes like reinfection, survival, and revision surgeries will be monitored up to two years. This study does not require extra tests or treatments beyond routine care and follows participants closely to evaluate treatment success and safety.

The trial investigates treatments for bloodstream infection caused by Staphylococcus aureus SAB, which can be life-threatening with a 15-30% death rate within three months. This international, multi-center randomized adaptive platform trial aims to find the best treatment options to reduce mortality within 90 days of infection. The trial adapts over time by assigning more patients to treatments that show better outcomes and removing less effective options. Participants receive various antibiotic treatments depending on their group. These include intravenous vancomycin or daptomycin, flucloxacillin or cloxacillin, cefazolin, or benzylpenicillin, with dosages adjusted for kidney function or illness severity. Some receive adjunctive drugs like clindamycin, and others may switch from intravenous to oral antibiotics if eligible after 7 or 14 days. Additionally, some participants undergo PETCT scans as part of the study. During the study, participants are monitored closely with blood cultures, temperature checks, and clinical assessments to track infection clearance and complications. Researchers measure all-cause mortality at 90 days as the primary outcome, along with other outcomes such as survival at earlier time points, hospital stay length, microbiological treatment failure, serious reactions, and antibiotic use. Safety and health economic data are also collected to evaluate treatments comprehensively throughout the trial.