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Набира участници Фаза 1

Study of HX15001 in Adult Healthy Volunteers.

Healthy Volunteers

This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants. The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9). The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.

Начало: 11.06.2025 Край: 30.09.2026 Възраст: 18–55 г. Лечение

Australia Helixon Biotechnology (Suzhou) Co., Ltd NCT06999720

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Bipolar-I Disorder With Mania or Mania With Mixed Features

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Начало: 11.06.2025 Край: 01.11.2026 Възраст: 18–65 г. Лечение

Argentina, Australia, Bulgaria +5 Bristol-Myers Squibb NCT06951698

Набира участници Фаза 1/2

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed

Gastrointestinal Neoplasms

This study will check how well a new medicine, GSK5764227, works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.

Начало: 11.06.2025 Край: 23.06.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +11 GlaxoSmithKline NCT06885034

Набира участници Фаза 1

Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension

Open Angle Glaucoma (OAG) Ocular Hypertension (OH)

The goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.

Начало: 10.06.2025 Край: 15.11.2026 Възраст: от 18 г. Лечение

Australia PolyActiva Pty Ltd NCT06964061

Набира участници Фаза 2

A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Autosomal Dominant Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 09.06.2025 Край: 01.08.2029 Възраст: 18–55 г. Лечение

Australia, Belgium, France +8 AbbVie NCT06902558

Набира участници Фаза 3

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

Bronchiectasis

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Начало: 09.06.2025 Край: 12.10.2028 Възраст: от 12 г. Лечение

Argentina, Australia, Belgium +40 Boehringer Ingelheim NCT06872892

Набира участници Фаза 3

A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE)

Friedreich Ataxia

In this study, researchers will learn more about the effects and safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedreich's Ataxia (FA) who are at least 16 years old. But, it is not yet available for children and teens with FA who are younger than 16 years old. The main objective of this study is to learn how BIIB141 works in the body and about its safety in children and teens who are 2 to 15 years old. The main questions researchers want to answer in this study are: * How does BIIB141 affect the participants' FA symptoms balance and stability? * How many participants have medical problems during the study? * Are there any changes in the participants' overall health during the study? * Are there any changes in the participants' heart health? * Are there any changes in how the participants move through puberty? Puberty is the time in someone's life when their body changes from a child to an adult. Researchers will also learn more about: \- How the body processes BIIB141 in children and teens This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * There are 2 parts in this study. During Part 1, participants will take either BIIB141 or a placebo once a day. * In Part 1, participants will take BIIB141 or the placebo in a study research center on Day 1, and then at in-person visits at Week 4, Week 12, Week 26, and Week 52. On all other days, they will take BIIB141 or the placebo at home. Part 1 lasts up to 52 weeks. * During Part 2, participants from Part 1 will either continue taking BIIB141 or start it if they were taking the placebo. Part 2 will last up to 104 weeks. * In Part 1, participants will have up to 10 visits to their study research center and a phone call at Week 2. In Part 2, participants will have visits at Weeks 4, 8,12, 26, and every 26 weeks after that until they leave the study, and a phone call at Week 2. There will be a final phone call to check on the participants' health 31 days after their last dose. * Each participant will be in the study for up to about 3 years

Начало: 09.06.2025 Край: 22.11.2029 Възраст: 2–15 г. Лечение

Australia, Brazil, Canada +11 Biogen NCT06953583

Набира участници

Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)

Breast Cancer Breast Cancer Female

The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery. The main question it aims to answer is: \* Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.

Начало: 06.06.2025 Край: 01.06.2039 Възраст: от 50 г. Друго

Australia, United States Breast Cancer Trials, Australia and New Zealand NCT06445738

Набира участници

Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX

AML - Acute Myeloid Leukemia

The goal of this observational study is to develop new ways to test new drug combinations to kill tumour cells, in patients with acute myeloid leukemia (AML). The main questions it aims to answer are: * Are there new ways to speed up discovery of better treatments for AML patients using AML cells from individual from patients in special mice that can accept human tissue? * Do these mice show treatment responses that are similar to the individual AML patient from whom cells were derived? Participants with AML who are taking standard of care treatment of venetoclax and azacitidine will be asked to donate blood and bone marrow samples for this study.

Начало: 06.06.2025 Край: 01.03.2030 Възраст: от 18 г.

Australia Clinical Hub for Interventional Research (CHOIR) NCT06782971

Набира участници Фаза 2

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

Multiple Sclerosis Spasticity

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

Начало: 05.06.2025 Край: 09.06.2027 Възраст: 18–70 г. Лечение

Australia, Canada, Czechia +4 Celgene NCT06782490

Набира участници Фаза 3

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

Cardiovascular Disease

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.

Начало: 04.06.2025 Край: 26.10.2029 Възраст: от 18 г. Лечение

Argentina, Brazil, Bulgaria +32 AstraZeneca NCT07000357

Набира участници Фаза 3

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Leukemia, Myeloid, Acute

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Начало: 04.06.2025 Край: 15.08.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +18 Janssen Research & Development, LLC NCT06852222

Набира участници Фаза 2

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Crohn's Disease

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.

Начало: 03.06.2025 Край: 17.10.2029 Възраст: 18–75 г. Лечение

Australia, Belgium, China +9 Sanofi NCT06958536

Набира участници

Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System

Persistent Atrial Fibrillation

The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.

Начало: 03.06.2025 Край: 01.01.2028 Възраст: от 18 г. Лечение

Australia, Taiwan, United States Boston Scientific Corporation NCT06735534

Набира участници Фаза 1

Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne

Acne

This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.

Начало: 03.06.2025 Край: 01.06.2026 Възраст: 18–55 г. Лечение

Australia, United States Sagimet Biosciences Inc. NCT06989840

Набира участници Фаза 1

A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants

Healthy

The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.

Начало: 03.06.2025 Край: 01.04.2026 Възраст: 18–55 г. Друго

New Zealand Shanghai Huaota Biopharmaceutical Co., Ltd. NCT06999083

Набира участници Фаза 2

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC) UC - Ulcerative Colitis

The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.

Начало: 02.06.2025 Край: 01.11.2026 Възраст: 18–75 г. Лечение

Australia, Canada, Czechia +6 Odyssey Therapeutics NCT06850727

Набира участници

Digitally Delivered Treatments to Reduce Chronic Low Back Pain

Low Back Pain Chronic Pain (Back / Neck) General Practice (GP), Primary Care Settings Digital Health +2

This study aims to evaluate the effectiveness of pain education and clinical hypnosis delivered via a mobile app compared to a guideline-informed factsheet for reducing pain and disability in people experiencing chronic low back pain attending general practice.

Начало: 02.06.2025 Край: 26.05.2028 Възраст: от 18 г. Лечение

Australia Neuroscience Research Australia NCT06984354

Набира участници Фаза 1/2

A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia

Friedreich Ataxia

The purpose of this study is to evaluate the safety and tolerability, and pharmacokinetics of DT-216P2 administered multiple ascending doses in patients with FA.

Начало: 01.06.2025 Край: 01.03.2027 Възраст: 18–65 г. Лечение

Australia Design Therapeutics, Inc. NCT06874010

Набира участници Фаза 1/2

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Uveal Melanoma Metastatic Uveal Melanoma Metastatic Uveal Melanoma in the Liver

A recent clinical trial found that after 36 months, patients taking tebentafusp had a median survival of 21.6 months, compared to 16.9 months for those in the control group. Since recruitment for tebentafusp in metastatic uveal melanoma (mUM) has ended, a new trial is starting to test whether adding IL-2 can help overcome resistance to tebentafusp and improve its effectiveness. This study aims to answer: 1. Can combining tebentafusp with IL-2 improve tumor response and overall survival? 2. What are the benefits and side effects of this combination therapy? All participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. The dosing schedule is as follows: Cycle1: Day1-3 IL-2 Day4 Tebentafusp Day 10 IL-2 Day 11 Tebentafusp Day 17 IL-2 Day 18 Tebentafusp Day 24 IL-2 Day 25 Tebentafusp Cycle 2 \& thereafter Day 1 IL-2 Day 2 Tebentafusp Day 8 IL-2 Day 9 Tebentafusp Day 15 IL-2 Day 16 Tebentafusp Day 22 IL-2 Day 23 Tebentafusp

Начало: 01.06.2025 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia St Vincent's Hospital, Sydney NCT07063875

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