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Набира участници Фаза 2

A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to

Achondroplasia

This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH, aged 0 to \< 2 years at the time of randomization.

Начало: 23.01.2024 Край: 01.12.2028 Възраст: до 2 г. Лечение

Australia, Canada, Denmark +10 Ascendis Pharma A/S NCT06079398

Набира участници Фаза 3

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

Multiple Myeloma

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

Начало: 22.01.2024 Край: 31.03.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Janssen Research & Development, LLC NCT06208150

Набира участници Фаза 3

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Vitiligo

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: * if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) * Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study * Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: * have non-segmental vitiligo (either active or stable) and * received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.

Начало: 19.01.2024 Край: 23.04.2027 Възраст: от 12 г. Лечение

Australia, Bulgaria, Canada +10 Pfizer NCT06163326

Набира участници Фаза 1/2

A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors

Advanced Solid Tumors That Are MTAP Deficient

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.

Начало: 18.01.2024 Край: 26.02.2026 Възраст: от 18 г. Лечение

Australia, China, France +5 AstraZeneca NCT06130553

Набира участници Фаза 1/2

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

Non-Small Cell Lung Cancer, NSCLC KRAS, NRAS, HRAS-mutated NSCLC KRAS G12C-mutated Solid Tumors, Lung Cancer Lung Cancer Stage IV, Advanced Solid Tumor, Cancer +1

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

Начало: 18.01.2024 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Denmark, France +7 Revolution Medicines, Inc. NCT06162221

Набира участници Фаза 3

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Heart Failure Acute Heart Failure

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Начало: 17.01.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +15 Colorado Prevention Center NCT06008197

Набира участници

Newborn Genomics Programme

Genetic Disease Newborn Morbidity

Genomic methods can significantly contribute to all facets of precision medicine, from diagnosis to prevention, therapeutic intervention, and management of acute and chronic illnesses. DNA based methods are already having a considerable impact across healthcare in fields that include: public health, infectious disease monitoring, acute and chronic disease, pharmacogenomics, prenatal testing and diagnosis, and therapeutic development. In this proposal, investigators are focusing on the application of genomic methods in precision medicine - specifically on rapid whole-genome sequencing of parents and children (i.e. a trio) for the identification of diseases that have genetic components. Goals Primary goal: is to provide safe rapid whole genome sequencing to Neonatal Intensive Care Unit/Pediatric Intensive Care Unit patients. Secondary goals: 1) Although several groups globally are implementing rapid sequencing of rare disease, these are predominantly in the research space, with many unanswered questions regarding the best way to implement them into a national healthcare system. Each country and their healthcare systems are unique, and valuable knowledge will be gained by implementing this process within a New Zealand context. As part of this the study will measure the impact on the individuals and families. 2\) to expand the research team's understanding of non-coding disease-causing variants and methylation changes that contribute to severe disease in early life. Primary Aims 1. To incorporate long-read RNA sequencing data into the diagnostic rapid Whole Genome Sequencing pipeline to provide a direct measure of the functional outcome of the variants of clinical concern. 2. To measure the clinical utility of analysing non-coding variants in the diagnosis of critically ill children who do not have pathogenic, likely pathogenic, or variants of unknown significance for mendelian disorders. 3. To identify, in a real-world setting within the New Zealand health-care system, the clinical and economic effects of deploying rapid Whole Genome Sequencing-informed rapid precision medicine for critically ill children.

Начало: 15.01.2024 Край: 01.12.2027 Възраст: до 2 г.

New Zealand Liggins Institute NCT06081075

Набира участници Фаза 3

A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma

Metastatic Head-and-neck Squamous-cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

The purpose of this study is to compare the efficacy and safety of ficlatuzumab plus cetuximab compared to placebo plus cetuximab in participants with recurrent/metastatic (R/M) HPV-negative Head and Neck Cancer. The primary hypothesis is that ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of progression-free survival and/or overall survival.

Начало: 11.01.2024 Край: 01.11.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Bulgaria +15 AVEO Pharmaceuticals, Inc. NCT06064877

Набира участници Фаза 1/2

Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

Cancer HLA-A*02:01-positive

This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\*02:01-positive participants with selected advanced PIWIL1-Positive cancers.

Начало: 10.01.2024 Край: 30.11.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Germany +3 Immunocore Ltd NCT06840119

Набира участници

CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

Intubation Complication Adverse Events

The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.

Начало: 08.01.2024 Край: 01.12.2025 Възраст: до 16 г.

Australia, Canada, Germany +2 Thomas Riva NCT05804188

Набира участници Фаза 3

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Advanced Cancer Metastatic Cancer

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

Начало: 05.01.2024 Край: 17.01.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +9 Daiichi Sankyo NCT06174987

Набира участници

A Global Study of the PETAL Consortium

T-Cell and NK-Cell Neoplasm

The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS), response rates for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning can be leveraged to uncover distinct genetic vulnerabilities that underlie treatment response and resistance for patients with TNKL, thus moving towards personalized treatment solutions.

Начало: 05.01.2024 Край: 01.01.2028 Възраст: от 18 г.

Australia, Japan, South Africa +1 Massachusetts General Hospital NCT06067347

Набира участници Фаза 1

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Solid Tumors

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Начало: 04.01.2024 Край: 01.01.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +5 Incyte Corporation NCT06179160

Набира участници Фаза 1

Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309

Advanced or Metastatic Solid Tumors

This is a Phase 1a/1b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and pharmacokinetics (PK) of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab.

Начало: 03.01.2024 Край: 30.04.2030 Възраст: от 18 г. Лечение

Australia PharmAbcine NCT05957081

Набира участници Ранна Фаза 1

Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough

Chronic Cough

Recently, a new drug called Gefapixant passed phase III clinical trials for cough suppression in patients with chronic cough. The goal of this clinical trial is to investigate the effect of acute and prolonged administration of the drug Gefapixant on cough-related brain activity in patients with chronic cough. The main question it aims to answer is: does the mechanism of action of Gefapixant on the brainstem and brain circuits regulating cough differ between acute and prolonged therapy in people with chronic cough? Participants have their brain activity and their sensitivity to cough-inducing substances measured as well as complete questionnaires about their cough before and while taking daily Gefapixant.

Начало: 01.01.2024 Край: 30.06.2026 Възраст: 18–65 г. Фундаментална наука

Australia Stuart Mazzone NCT05813223

Набира участници Фаза 3

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Prostate Cancer Metastatic

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Начало: 31.12.2023 Край: 02.08.2028 Лечение

Argentina, Australia, Brazil +31 Merck Sharp & Dohme LLC NCT06136624

Набира участници Фаза 3

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

Breast Cancer

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Начало: 30.12.2023 Край: 01.10.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +7 Daiichi Sankyo NCT05950945

Набира участници Фаза 1/2

AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia

B-cell Acute Lymphoblastic Leukemia (B-ALL)

This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

Начало: 29.12.2023 Край: 29.06.2027 Възраст: от 12 г. Лечение

Australia, Brazil, Canada +10 AstraZeneca NCT06137118

Набира участници Фаза 3

A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Relapsed/Refractory Follicular Lymphoma Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug in combination with lenalidomide * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality-of-life and ability to complete routine daily activities

Начало: 28.12.2023 Край: 23.01.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +14 Regeneron Pharmaceuticals NCT06149286

Набира участници

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Hypertension Hypertension, Systolic Hypertension, Essential

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.

Начало: 27.12.2023 Край: 01.08.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Czechia +8 Orchestra BioMed, Inc NCT06059638

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