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Набира участници Фаза 3

Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Neovascular Age-Related Macular Degeneration (nAMD)

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Начало: 22.07.2025 Край: 01.02.2029 Възраст: от 50 г. Лечение

Argentina, Australia, Bulgaria +11 4D Molecular Therapeutics NCT07064759

Набира участници Фаза 1

Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Solid Tumor Malignancies EGFR Positive Solid Tumors EGFR

This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR. The study will be conducted in the following 4 parts: * Part 1: VIR-5525 monotherapy dose escalation * Part 2: VIR-5525 monotherapy dose expansion * Part 3: VIR-5525 plus pembrolizumab dose escalation * Part 4: VIR-5525 plus pembrolizumab dose expansion

Начало: 22.07.2025 Край: 01.08.2029 Възраст: от 18 г. Лечение

Australia, United States Vir Biotechnology, Inc. NCT06960395

Набира участници Фаза 2/3

Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors

Pancreatic Neuroendocrine Tumor (pNET) Extra-Pancreatic Neuroendocrine Tumor (epNET)

The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.

Начало: 21.07.2025 Край: 01.06.2029 Възраст: от 18 г. Лечение

Australia, Canada, China +9 Exelixis NCT06943755

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Начало: 21.07.2025 Край: 23.02.2029 Възраст: 60–85 г. Лечение

Argentina, Australia, Brazil +13 Bristol-Myers Squibb NCT06976203

Набира участници Фаза 2

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

Solid Tumors

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Начало: 18.07.2025 Край: 30.06.2030 Възраст: от 18 г. Лечение

Australia, China, Taiwan +1 DualityBio Inc. NCT06953089

Набира участници Фаза 2

Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

Acute Myeloid Leukemia Leukemia

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Начало: 18.07.2025 Край: 14.07.2032 Възраст: от 18 г. Лечение

Australia, Brazil, China +2 Daiichi Sankyo NCT06824168

Набира участници Фаза 2

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

Chronic Kidney Disease

This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease. In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants are in the study for about 4.5 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine. The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.

Начало: 18.07.2025 Край: 20.08.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Boehringer Ingelheim NCT06926660

Набира участници

Analysis of the Efficacy of Pressure Pad vs Pressure Bandage Immobilisation for Snake Bite First Aid in Healthy Volunteers.

Snake Bites Snakebite Snake Envenomation Snake Bite +1

Snake bite affects thousands of Australians every year, but few die as a result due to high quality first aid and timely medical care. Good first aid should be simple, standardised, use minimal or readily available equipment, and be able to be utilised effectively with no or minimal training by the rescuer. Over time the first aid methods used to manage snake bite in Australia have been questioned due to issues with efficacy, and some emerging evidence of harm from their use. There is little experimental data in the literature to support current first aid practices, and what exists suggests further research is required. This study aims to examine and compare the effectiveness of two first aid methods by tracking the movement of a mock venom through the body when each first aid method is used. This will provide important information about the suitability of current techniques used in Australia and whether a proposed simpler alternative technique is as effective. Currently, initial treatment of snake bite involves early first aid with the application of a pressure bandage and immobilisation (PBI) of the limb. There is limited data to support the basis of this technique and emerging evidence of harm when applied incorrectly. This project sets out to evaluate PBI compared to another technique involving the application of a pressure pad (PP) at the bite site (which is easier to do, and used in many countries outside of Australia). The project aims to determine whether each technique is effective, and whether the PP technique is at least as effective as PBI. To do this 24 participants will be recruited to undergo study with mock venom injected into their hand or foot and having either PBI or PP applied. The mock venom will then be traced with a gamma camera to determine rate of flow through the lymphatic system, which is how venom travels in the body. It is expected that the project will demonstrate the efficacy of both techniques, and that the PP will be at least as effective as PBI. This will provide a basis for change in the current first aid recommendations for snake bite first aid in Australia, and improve the care provided.

Начало: 18.07.2025 Край: 01.02.2027 Възраст: от 18 г. Поддържаща грижа

Australia Townsville University Hospital NCT07261982

Набира участници Фаза 3

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Non-small Cell Lung Cancer Anaplastic Lymphoma Kinase-positive

Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Начало: 17.07.2025 Край: 01.12.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Nuvalent Inc. NCT06765109

Набира участници Фаза 2

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Early Alzheimer's Disease

Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it

Начало: 16.07.2025 Край: 30.04.2029 Възраст: 50–85 г. Лечение

Argentina, Australia, Belgium +6 Merck Sharp & Dohme LLC NCT07033494

Набира участници Фаза 2

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Systemic Lupus Erythematosus Active Refractory Rheumatoid Arthritis

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).

Начало: 16.07.2025 Край: 09.03.2029 Възраст: 18–75 г. Лечение

Australia, Belgium, France +6 Amgen NCT06570798

Набира участници Фаза 1

Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors

Advanced Solid Tumor Metastatic Solid Tumor Endometrial Cancer MSI-H Cancer +3

This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.

Начало: 16.07.2025 Край: 01.05.2028 Възраст: от 18 г. Лечение

Australia, United States MOMA Therapeutics NCT06974110

Набира участници Фаза 2

A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)

Chronic Hepatitis B Infection

This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.

Начало: 15.07.2025 Край: 01.08.2028 Възраст: 18–65 г. Лечение

Bulgaria, Canada, China +11 Aligos Therapeutics NCT06963710

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Alzheimer's Disease

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Начало: 14.07.2025 Край: 23.02.2029 Възраст: 60–85 г. Лечение

Argentina, Australia, Brazil +14 Bristol-Myers Squibb NCT06976216

Набира участници Фаза 3

Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Androgenetic Alopecia Male Pattern Baldness

This is a phase 3, multicentre, randomised, double-blinded, placebo-controlled study examining the safety and efficacy of 2.5 mg sublingual (SL) minoxidil tablets taken twice daily in the treatment of androgenetic alopecia (AGA) in men. The duration of study participation is 32 weeks including screening and safety follow up. The primary efficacy objective is to determine whether treatment with 2.5 mg SL tablets twice daily increases the number of hairs in men with AGA over 24 weeks. The primary safety objective is to evaluate the safety and tolerability of 2.5 mg SL tablets administered twice daily over 24 weeks.

Начало: 14.07.2025 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia Samson Clinical Operations Pty Ltd NCT06924632

Набира участници Ранна Фаза 1

Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

Cutaneous Lupus Erythematosus

The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2. Part 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.

Начало: 14.07.2025 Край: 01.03.2026 Възраст: 18–64 г. Лечение

Australia Noxopharm Limited NCT07072611

Набира участници

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

Heart Defects, Congenital Anxiety in Pregnancy Depression, Postpartum Trauma, Psychological +1

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

Начало: 14.07.2025 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, United States Children's Hospital Medical Center, Cincinnati NCT06175104

Набира участници Фаза 1

Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults

Healthy

Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of lobeglitazone administered as M107 Orally Disintegrating Tablet and Duvie tablet in healthy adult participants under fasted and fed conditions.

Начало: 11.07.2025 Край: 02.09.2025 Възраст: 18–55 г. Лечение

Australia Aclipse Two Inc. NCT07056517

Набира участници Фаза 2

ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas

Diffuse Intrinsic Pontine Gliomas (DIPG) Progressive DIPG Refractory DIPG Recurrent DIPG +1

This is a Phase II open-label study to investigate the safety and efficacy of ACT001 in patients with DIPG and H3K27-altered HGG.

Начало: 10.07.2025 Край: 01.07.2035 Възраст: 12–39 г. Лечение

Australia, Canada, Germany +2 Nationwide Children's Hospital NCT06838676

Набира участници

Steps Against the Burden of Parkinson's Disease

Parkinson Disease (PD)

Parkinson's Disease Treadmill Training RCT Summary Parkinson's disease (PD) affects over 10 million people globally. Despite optimal pharmacological treatment, approximately 70% of individuals experience unstable gait and falls, leading to loss of confidence, social isolation, fractures, and frequent hospitalisations. Treadmill training-especially when augmented by mechanical or virtual-reality perturbations-has shown promise in improving gait and reducing fall risk. However, the mechanisms underlying these benefits remain poorly understood, limiting the ability to personalise interventions effectively. This randomised controlled trial (RCT) forms part of the broader Steps Against the Burden of Parkinson's Disease project (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004), comprising three harmonised but independently conducted RCTs. All sites follow a shared core protocol, allowing for pooled data analysis while preserving site-specific perturbation adaptations. Findings from this trial will be reported both independently and as part of the combined dataset. In this trial, participants with PD will undergo 12 sessions of treadmill training, with or without virtual reality and perturbation-based adaptations. Assessments will be conducted at baseline, post-training, and follow-up. The intervention aims to enhance gait through improved sensorimotor integration and balance control. During the follow-up period, a smartphoneapp "Walking Tall" will be used to encourage continued exercises and long-term retention of training effects. Biomechanical analyses will focus on changes in foot placement control. Neurophysiological outcomes will be examined using EEG and EMG, targeting reductions in beta-band EEG power and enhanced EEG-EMG coherence as markers of improved gait stability. Recognising that laboratory-based improvements may not always translate to daily life, this study will also investigate gait self-efficacy as a potential moderator of transfer. Remote monitoring tools will capture real-world mobility outcomes over a week. Machine learning techniques will be employed to identify factors differentiating those who improve in both settings from those who do not. These insights will inform the development of personalised interventions capable of translating training effects into meaningful real-life outcomes.

Начало: 09.07.2025 Край: 30.11.2026 Възраст: от 18 г. Фундаментална наука

Australia The University of New South Wales NCT07057219

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