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Активно (без набиране)

Esprit BTK Post-Approval Study

Chronic Limb-Threatening Ischemia

The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.

Начало: 21.10.2024 Край: 30.05.2029 Възраст: от 18 г. Лечение

Hong Kong, New Zealand, United Arab Emirates +1 Abbott Medical Devices NCT06656364

Активно (без набиране) Фаза 2

A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS (within 2 years of ALS symptoms onset). The study comprises a core double-blind (DB) 40-week treatment period followed by an open label extension (OLE).

Начало: 17.10.2024 Край: 07.07.2028 Възраст: 18–100 г. Лечение

Australia, Belgium, Canada +12 Novartis Pharmaceuticals NCT06643481

Активно (без набиране) Фаза 2

A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis

Eosinophilic Esophagitis (EoE)

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.

Начало: 16.10.2024 Край: 31.08.2027 Възраст: 18–75 г. Лечение

Australia, Belgium, Italy +6 Uniquity One (UNI) NCT06598462

Активно (без набиране) Фаза 2

A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)

Classical Hodgkin Lymphoma Recurrent Classical Hodgkin Lymphoma Refractory Primary Mediastinal Large B-cell Lymphoma Recurrent Primary Mediastinal Large B-cell Lymphoma Refractory

The primary purpose of the study is to assess the pharmacokinetics (PK) profile of pembrolizumab following subcutaneous (SC) injection of pembrolizumab coformulated with hyaluronidase, and to evaluate the objective response rate (ORR) of pembrolizumab (+) berahyaluronidase alfa SC in adult participants with Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL). There is no formal hypothesis to be tested for this study.

Начало: 14.10.2024 Край: 08.11.2028 Възраст: от 18 г. Лечение

Australia, Chile, Germany +8 Merck Sharp & Dohme LLC NCT06504394

Активно (без набиране) Фаза 1

An Investigational Study of BG-89894 Tablets in Participants With Advanced Solid Tumors

Advanced or Metastatic MTAP-deleted Solid Tumors

This study is being done to learn more about a new drug called BG-89894 (previously known as SYH2039). Researchers want to see if the drug is safe, how well people can tolerate it, how it moves through the body, and whether it shows any early signs of helping to treat cancer. The information gathered may help guide how future studies are designed. The entire study is expected to last about four years. People who join the study may receive treatment for around six months and will be followed for about 12 months after their treatment ends. The study plans to enroll participants over a three-year period.

Начало: 12.10.2024 Край: 30.04.2026 Възраст: от 18 г. Лечение

Australia, China, United States BeOne Medicines NCT06568614

Активно (без набиране) Фаза 1

A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

Advanced Solid Tumors

The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Начало: 10.10.2024 Край: 14.10.2027 Възраст: от 18 г. Лечение

Australia, Canada, United States Bristol-Myers Squibb NCT06544655

Активно (без набиране) Фаза 3

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Prurigo Nodularis

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Начало: 10.10.2024 Край: 03.05.2027 Възраст: 18–75 г. Лечение

Australia, Belgium, Canada +8 Incyte Corporation NCT06516965

Активно (без набиране) Фаза 3

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

HIV-1-infection

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Начало: 09.10.2024 Край: 01.08.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +9 Gilead Sciences NCT06630286

Активно (без набиране) Фаза 3

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

HIV-1-Infection

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.

Начало: 08.10.2024 Край: 01.08.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Germany +11 Gilead Sciences NCT06630299

Активно (без набиране)

BIO|MASTER.CSP Study

Cardiac Pacing, Artificial Cardiac Pacemaker, Artificial Cardiac Resynchronization Therapy Devices Bradycardia +3

The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs. The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.

Начало: 04.10.2024 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia, Belgium, France +2 Biotronik SE & Co. KG NCT06620237

Активно (без набиране) Фаза 1/2

Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects

Hypertriglyceridemia Familial Chylomicronemia Syndrome

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN0361 in Adult healthy subjects and Adult Hypertriglyceridemic Subjects.

Начало: 30.09.2024 Край: 26.08.2026 Възраст: 18–70 г. Лечение

Australia, United States Ikaria Bioscience Pty Ltd NCT06471543

Активно (без набиране) Фаза 1

A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years

Respiratory Syncytial Virus Infections

The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.

Начало: 30.09.2024 Край: 13.04.2026 Възраст: 18–45 г. Превенция

Australia, Spain, United States GlaxoSmithKline NCT06573281

Активно (без набиране) Фаза 3

A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis

Acute Gastroenteritis Norovirus Acute Gastroenteritis

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.

Начало: 24.09.2024 Край: 15.02.2027 Възраст: от 18 г. Превенция

Australia, Canada, Japan +4 ModernaTX, Inc. NCT06592794

Активно (без набиране) Фаза 1

Evaluation of Xaluritamig in High-Risk, Biochemically Recurrent, Non-metastatic Castrate-sensitive Prostate Cancer

Prostate Cancer High-risk Biochemical Recurrence High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer Non-metastatic Castration-sensitive Prostate Cancer

The main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (BCR) nonmetastatic castration-sensitive prostate cancer (nmCSPC).

Начало: 23.09.2024 Край: 02.12.2028 Възраст: от 18 г. Лечение

Australia, United States Amgen NCT06555796

Активно (без набиране) Фаза 3

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications

Parkinson Disease

This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424 or 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

Начало: 20.09.2024 Край: 01.08.2026 Възраст: от 30 г. Лечение

Australia, Czechia, France +6 Cerevance NCT06553027

Активно (без набиране) Фаза 1

Phase 1 Study of ART5803 in Healthy Participants

Autoimmune Encephalitis

The study is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ART5803 compared with placebo in healthy adult participants

Начало: 19.09.2024 Край: 11.03.2026 Възраст: 18–65 г. Друго

Australia Arialys Therapeutics NCT06575153

Активно (без набиране) Фаза 3

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

Myasthenia Gravis, Ocular

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.

Начало: 18.09.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +19 argenx NCT06558279

Активно (без набиране) Фаза 2

A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

Melanoma

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug(s). * How much study drug(s) is in the blood at different times. * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.

Начало: 18.09.2024 Край: 09.12.2030 Възраст: от 18 г. Лечение

Australia, Canada, France +4 Regeneron Pharmaceuticals NCT06190951

Активно (без набиране) Фаза 3

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Начало: 17.09.2024 Край: 30.01.2031 Възраст: 16–80 г. Лечение

Argentina, Australia, Belgium +25 Hoffmann-La Roche NCT06589986

Активно (без набиране) Фаза 2

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Multiple Myeloma

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Начало: 16.09.2024 Край: 26.08.2027 Възраст: от 18 г. Лечение

Australia, United States Janssen Research & Development, LLC NCT06550895

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