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Набира участници Фаза 3

Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes

Acute Coronary Syndrome

The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.

Начало: 03.10.2025 Край: 15.02.2027 Възраст: от 18 г. Лечение

Australia, Canada, China +10 Novartis Pharmaceuticals NCT07102628

Набира участници

Closed Loop and Education for Hypoglycemia Awareness Restoration

Diabetes Mellitus, Type 1

The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.

Начало: 03.10.2025 Край: 31.07.2029 Възраст: 18–75 г. Лечение

Australia, United Kingdom, United States Milton S. Hershey Medical Center NCT06325202

Набира участници Фаза 2/3

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Crohn Disease

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Начало: 03.10.2025 Край: 06.10.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Janssen Research & Development, LLC NCT07196722

Набира участници Фаза 3

CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

Начало: 02.10.2025 Край: 29.06.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +16 Novo Nordisk A/S NCT07207811

Набира участници Фаза 1

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

Начало: 01.10.2025 Край: 14.12.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Germany +2 Incyte Corporation NCT07008118

Набира участници Фаза 2

Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

Adjustment Disorder Adjustment Disorder With Anxious Mood Cancer Cancer Cachexia +7

This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day). At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

Начало: 01.10.2025 Край: 30.07.2027 Възраст: 18–80 г. Лечение

Australia Psyence Australia Pty Ltd NCT07072728

Набира участници Фаза 1

Serum Collection Study for Assay Development

Pneumococcal Disease, Invasive Pneumococcal Disease

The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation

Начало: 01.10.2025 Край: 01.06.2026 Възраст: 18–69 г. Диагностика

Australia GPN Vaccines NCT07205289

Набира участници Фаза 2

A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)

Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension, Interstitial Lung Disease

This study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval/authorization.

Начало: 01.10.2025 Край: 01.03.2029 Възраст: от 18 г. Лечение

Australia, Canada, France +4 AllRock Bio, Inc. NCT07175038

Набира участници Фаза 3

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Начало: 01.10.2025 Край: 13.01.2032 Възраст: от 12 г. Лечение

Argentina, Australia, Belgium +23 Janssen Research & Development, LLC NCT07196748

Набира участници Фаза 1

A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma

Metastatic Melanoma

This is Phase I, open label, multi-center clinical trial evaluating an investigational treatment, Adze1.C. Adze1.C is a type of oncolytic virus therapy for adults with advanced Melanoma that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight tumors. The purpose of this study is to determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.

Начало: 01.10.2025 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia Adze Biotechnology Australia Pty Ltd NCT07086105

Набира участници Фаза 1/2

Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors

Advanced Tumors

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.

Начало: 01.10.2025 Край: 30.06.2031 Възраст: от 18 г. Лечение

Australia, Israel ModeX Therapeutics, An OPKO Health Company NCT07110584

Набира участници Фаза 1

A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

Locoregionally Recurrent Hormone-receptor Positive Breast Cancer Metastatic Hormone Receptor Positive Breast Cancer

A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.

Начало: 01.10.2025 Край: 01.06.2033 Възраст: от 18 г. Лечение

Australia, United States Radionetics Oncology NCT07121244

Набира участници

Prostate Adaptive Radiation Therapy

Prostatic Neoplasms

Prostate ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for prostate cancer patients. Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced. Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2. Part 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for prostate cancer patients.

Начало: 01.10.2025 Край: 31.10.2031 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT06547398

Набира участници Фаза 2/3

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

Urothelial Cancer

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Начало: 30.09.2025 Край: 18.11.2033 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +17 Bristol-Myers Squibb NCT07106762

Набира участници Фаза 1/2

Safety of Single and Repeat Dose of PYC-001 Eye Injections in People With Autosomal Dominant Optic Atrophy (Myrtle)

OPA1 Gene Mutation Autosomal Dominant Optic Atrophy Hereditary Optic Atrophies Kjer Optic Atrophy

This study aims to gather safety data and determine the optimal dosing regimen for PYC-001 in participants with confirmed OPA1 mutation-associated ADOA. Approximately 18 participants from Australia, New Zealand, and other APAC countries are expected to be enrolled, depending on safety review committee (SRC) throughout the course of the study. Participants may be assigned to any of the following: 1. A single 60ug dose of PYC-001 2. Three doses of 10ug PYC-001 at an interval of 8 weeks 3. Three doses of 10ug PYC-001 at an interval of 12 weeks 4. Three doses of 30ug PYC-001 at an interval of 8 weeks 5. Three doses of 30ug PYC-001 at an interval of 12 weeks Following completion of the 4 week safety review of the single 60ug of PYC-001 cohort, and if the 60 μg dose level is deemed safe by the SRC, the following cohorts will also be available: 6. Three doses of 60ug PYC-001 at an interval of 12 weeks

Начало: 30.09.2025 Край: 01.01.2028 Възраст: от 18 г. Лечение

Australia, New Zealand PYC Therapeutics NCT06970106

Набира участници Фаза 1/2

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

Hypophosphatasia (HPP)

This is a phase 1/2a randomised, placebo controlled, double-blind study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALE1 on healthy adult subjects and adult patients with Hypophosphatasia (HPP).

Начало: 30.09.2025 Край: 01.01.2027 Възраст: 18–50 г. Лечение

New Zealand, United Kingdom Alesta Therapeutics NCT07179640

Набира участници Фаза 3

This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

Metastatic Castration Sensitive Prostate Cancer (mCSPC) Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.

Начало: 28.09.2025 Край: 08.12.2034 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Pfizer NCT07028853

Набира участници

Akyva First In Human

Underactive Bladder

The goal of this study is to check if the study device, the Akyva System, is safe to use and to find out if it has any possible side effects. Researchers will see if the study device can help you urinate without the need for catheterization, which involves passing a catheter (small tube) into the bladder, and if there is improvement in the leftover urine amount in your bladder after urinating or trying to urinate.

Начало: 24.09.2025 Край: 01.09.2028 Възраст: 22–70 г. Лечение

Australia Iota Biosciences, Inc NCT06956209

Набира участници Фаза 1/2

A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

B-cell Non-Hodgkin Lymphoma

This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).

Начало: 24.09.2025 Край: 01.03.2028 Възраст: от 18 г. Лечение

Australia, China, Italy +5 AstraZeneca NCT07123454

Набира участници Фаза 1

A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

Advanced/Metastatic Solid Tumors

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Начало: 23.09.2025 Край: 01.06.2028 Възраст: от 18 г. Лечение

Australia, United States DualityBio Inc. NCT07141706

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