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Набира участници Фаза 1

Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This is a Phase 1, First-in-Human study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of PYC-003 in healthy adult participants and adult participants with confirmed PKD1 mutation-associated Autosomal Dominant Polycystic Kidney Disease (ADPKD) There are 3 parts in this study, i.e. Part A, Part B and Part C

Начало: 07.04.2025 Край: 01.03.2027 Възраст: 18–65 г. Лечение

Australia, New Zealand PYC Therapeutics NCT06714006

Набира участници Фаза 2

Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

Hyperkalemia

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.

Начало: 06.04.2025 Край: 01.12.2030 Възраст: до 11 г. Лечение

Australia, Belgium, Finland +11 Vifor Pharma, Inc. NCT05766839

Набира участници Фаза 3

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).

Начало: 04.04.2025 Край: 01.10.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Gilead Sciences NCT06801834

Набира участници Фаза 1/2

Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Advanced HR+/HER2- Breast Cancer Advanced CCNE1-amplified Solid Tumors

Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

Начало: 03.04.2025 Край: 25.09.2028 Възраст: 18–100 г. Лечение

Australia, Canada, China +12 Novartis Pharmaceuticals NCT06726148

Набира участници Фаза 1

A Phase 1 Study of S-4321

Healthy Volunteer

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Начало: 03.04.2025 Край: 01.04.2026 Възраст: 18–65 г. Лечение

Australia Seismic Therapeutic AU Pty Ltd NCT06877611

Набира участници Фаза 1

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

Solid Tumours Advanced Solid Tumours

This is a multi-centre, two-part, open-label, phase 1, first in human study of multiple ascending doses of RC220 bisantrene formulation alone and in combination with fixed dose doxorubicin to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) in adult patients with advanced solid tumours where an anthracycline may be considered as a treatment option / or is indicated. The study will consist of Part 1 - dose-escalation, to determine the maximum tolerated combination dose of RC220 with doxorubicin to be evaluated in Part 2 - dose-expansion cohort, in patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated. The objective of Part 2 will be to confirm the safety and tolerability and evaluate the preliminary cardioprotective and anti-tumour efficacy of the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin.

Начало: 02.04.2025 Край: 31.01.2029 Възраст: от 18 г. Лечение

Australia, Hong Kong Race Oncology Ltd NCT06815575

Набира участници

The Dragon PLC Trial (DRAGON-PLC)

Primary Liver Cancer Hepatocellular Carcinoma (HCC) Cholangiocarcinoma

The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma. The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy. Participants will: * Undergo either standard PVE or combined PVE and HVE. * Have regular imaging to assess liver resectability. * Be monitored for survival outcomes up to 5 years after intervention.

Начало: 01.04.2025 Край: 15.11.2032 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +7 Maastricht University NCT06914648

Набира участници

Maintenance rTMS for Depression (Maitr-De)

Major Depressive Disorder Treatment Resistant Depression

Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising intervention for treatment-resistant depression (TRD), yet substantial uncertainties persist regarding its efficacy as a maintenance treatment. This prospective study seeks to investigate the efficacy of maintenance rTMS in individuals with TRD who have previously responded to an acute course of rTMS. In the R61 phase of the study, we will recruit 75 participants across three study sites, the University of California San Diego, Weill Cornell Medicine, and Australian National University, into a double-blind, three-arm maintenance treatment trial. In this trial, participants will be randomized to receive either standard maintenance rTMS, clustered maintenance rTMS, or sham maintenance rTMS for a duration of 6 months. Our primary aim is to examine the efficacy of maintenance rTMS on sustaining connectivity between the dorsolateral prefrontal cortex (DLPFC) and subgenual cingulate cortex (SGC) measured through concurrent TMS and electroencephalography (TMS-EEG) at baseline and every six weeks throughout the 6-month treatment period. We will also assess changes in depressive symptom severity using clinical scales, including the Montgomery-Asberg Depression Rating Scale (MADRS) as a secondary outcome measure. It is hypothesized that stimulation with clustered maintenance rTMS will demonstrate superiority in sustaining DLPFC-SGC connectivity compared with standard maintenance rTMS and sham maintenance rTMS

Начало: 01.04.2025 Край: 31.03.2026 Възраст: 18–80 г. Лечение

Australia, United States University of California, San Diego NCT06938841

Набира участници Фаза 3

Tissue Repair Gel in Venous Leg Ulcers in AU/US

Venous Leg Ulcer Venous Ulcer Venous Stasis Ulcer Venous Stasis +4

The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.

Начало: 01.04.2025 Край: 01.02.2027 Възраст: от 18 г. Лечение

Australia, United States TR Therapeutics NCT06707103

Набира участници

De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)

HPV Positive Oropharyngeal Squamous Cell Carcinoma

The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy. The main questions it aims to answer are: 1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection? 2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT? 3. What are the acute and late toxicities in patients selected for radiation dose de-escalation? 4. What are the quality of life scores in patients selected for radiation dose de-escalation? 5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation? Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response. Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy).

Начало: 01.04.2025 Край: 01.12.2031 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT06307015

Набира участници

Sutra Hemi-valve First-in-Human Study

Mitral Regurgitation

Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for surgical treatment.

Начало: 01.04.2025 Край: 01.04.2026 Възраст: от 18 г. Лечение

New Zealand Sutra Medical, Inc. NCT06552689

Набира участници

Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand

Healthy

Currently, one in five rangatahi (young people) in Aotearoa report difficulty accessing support for their mental health concerns. This treatment gap has prompted academics and clinicians to consider whether online and/or school-based interventions can increase access to evidence-based mental health care. This research is a randomised controlled trial to evaluate the effectiveness of Project SOLVE, an online problem-solving intervention, compared to Project Success, an activity that teaches young people study skills. Underdeveloped problem-solving skills have been associated with varying presentations of mental distress, including depression, hopelessness, and suicidal ideation. This association has meant problem solving is often featured as a core component of therapeutic interventions, and strengthening problem solving skills has been shown to improve clinical outcomes in youth who experience mental health concerns. For these reasons, the investigators hope that Project SOLVE will support the development of problem solving in rangatahi in Aotearoa and have a positive effect on their proximal and longitudinal mental health outcomes.

Начало: 30.03.2025 Край: 30.06.2025 Възраст: 12–14 г. Друго

New Zealand The University of Waikato NCT06896071

Набира участници Фаза 2

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

Colitis Ulcerative

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

Начало: 28.03.2025 Край: 11.05.2028 Възраст: 18–75 г. Лечение

Argentina, Australia, Belgium +18 Sanofi NCT06867094

Набира участници Фаза 2

A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

CTCL

This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.

Начало: 28.03.2025 Край: 01.06.2028 Възраст: от 18 г. Лечение

Australia, France, Italy +1 Prescient Therapeutics, Ltd. NCT06854653

Набира участници

Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma

Diffuse Large B-cell Lymphoma Follicular Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections) and the most common type of non-Hodgkin lymphoma. Follicular Lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the real-world effectiveness of subcutaneous epcoritamab in adult participants with advanced DLBCL and FL. Epcoritamab is an investigational drug being developed for treating participants with DLBCL and FL. Approximately 700 participants will be enrolled in approximately 80 sites across 12-20 countries globally. Participants will receive epcoritamab as prescribed by their physician in accordance with local country label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Начало: 28.03.2025 Край: 01.09.2031 Възраст: от 18 г.

Argentina, Australia, Belgium +9 AbbVie NCT06830759

Набира участници Фаза 3

DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

Endometrial Cancer

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Начало: 27.03.2025 Край: 19.02.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +17 AstraZeneca NCT06989112

Набира участници Фаза 1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA)

This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.

Начало: 27.03.2025 Край: 25.06.2029 Възраст: 18–75 г. Лечение

Australia, Bosnia and Herzegovina, New Zealand +1 Sanofi NCT06647069

Набира участници Фаза 2

Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer

Lung Cancer - Non Small Cell Squamous Lung Cancer - Non Small Cell Non-Squamous

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.

Начало: 27.03.2025 Край: 27.02.2031 Възраст: от 18 г. Лечение

Australia, United States Merus B.V. NCT07353957

Набира участници Фаза 1/2

Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years

Chlamydia Trachomatis Immunization

The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of different dose levels (low, medium, and high) of Chlamydia messenger ribonucleic acid (mRNA) Vaccine candidate in adult participants aged 18 to 29 years. This study will consist of 3 Sentinel Cohorts and a Main Cohort, with the Sentinel Cohorts assessing the safety of the different dose levels in a stepwise manner. All participants will be followed up to 12 months after the last study intervention administration. Thus, the expected duration of the participant's involvement will be 18 months.

Начало: 27.03.2025 Край: 03.01.2028 Възраст: 18–29 г. Превенция

Australia Sanofi NCT06891417

Набира участници Фаза 2/3

Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS

Amyotrophic Lateral Sclerosis

Phase II/III multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the efficacy of ALCAR (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale. Secondary study aims: 1. The effect of ALCAR treatment on different clinical aspects: functional decline as measured by ALSFRS-R total score; the decline of forced vital capacity (FVC); quality of life as measured by ALSAQ-40 scale; cognitive function as measured by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) scale; survival (being alive and without tracheostomy). 2. To measure the effects of ALCAR treatment on disease biomarkers potentially involved in the drug's mechanisms of action. These include PGC-1 alpha, 3-nitrotyrosine (3-NT), acetyl cyclophilin A (acetyl-PPIA), neurofilament light chain (NFL), creatine kinase (CK), Musclin/osteocrin, MyomiRNA (MiR-206), Uric acid, Matrix metalloproteinase-9 (MMP-9), Monocyte Chemoattractant Protein-1 (MCP-1), 4-Hydroxynonenal (HNE). 3. The tolerability and safety of ALCAR treatment by identifying unexpected adverse events. Study population: 246 subjects will be enrolled on one Australian and ten Italian ALS sites. Inclusion criteria: subjects aged 18+ years with a diagnosis of ALS according to Gold Coast Criteria; disease duration \= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening, treatment with Riluzole in the last four weeks. Exclusion criteria: antecedent polio infection; other motor neuron disease; involvement of other systems possibly determining a functional impairment; other severe clinical conditions; unwillingness or inability to take riluzole; previous use of ALCAR for any reason; inability to understand and comply with the study requirements, and to give written informed consent personally or via their legally authorized representative. All eligible participants will be randomized to receive ALCAR (1,5 or 3 g/day) or placebo in addition to riluzole 50 mg b.i.d. Permuted block (with a block size of 6), 1:1:1 centralized randomization scheme will be used. The overall treatment duration will be 48 weeks. After enrolment, each participant will be followed up until death. Eligible subjects will be seen after 4, 12, 24, 36 and 48 weeks. At each visit, a general assessment will be made, including vital signs, body mass index (BMI), neurological examination (including quantitative and qualitative evaluation of the motor system), comorbidity, concomitant treatments and adverse events. Blood samples will be collected at baseline -Day 1 (randomization)-, 4, 12, 24, 36 and 48 weeks to test biomarkers. Functional disability will be assessed at each visit using the ALS-FRS-R scale. The respiratory function will be assessed using a spirometer to measure FVC before starting treatment (baseline visit) and at 4, 12, 24, 36 and 48 weeks. Cognitive function will be evaluated at baseline, weeks 24 and 48, using ECAS scale. Health-related quality of life, measured by the ALSAQ-40, will be tested at baseline, 24 and 48 weeks. Compliance will be tested by the local investigators, counting unused packages at each follow-up visit. Pre-planned statistical analyses will be done on Intention-to-treat and Per-protocol (PP) populations. The statistical plan will include descriptive statistics and a comparison of the proportions of self-sufficient participants at week 48 using the chi-square or Fisher's exact test for the primary endpoint. Secondary endpoints measured by numerical scores obtained from clinical scales will be analyzed using repeated measures mixed models, while biomarkers using repeated measures ANOVA. Time-to-event endpoints, such as survival and the probability of remaining self-sufficient over 48 weeks, will be analyzed with Kaplan-Meier curves. The number of adverse events and serious adverse events after 48 weeks will be compared between treatment arms.

Начало: 26.03.2025 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia, Italy Mario Negri Institute for Pharmacological Research NCT06126315

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