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Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epi1
Rapport Therapeutics Inc.
Focal Onset Seizures
This is a clinical research study for an investigational drug called RAP-219 in patients
with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219
works and is safe in patients with Refractory Focal Epilepsy. expand
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy. Type: Interventional Start Date: Oct 2024 |
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multi1
Sanofi
Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and
tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or
NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3
tolebrutinib pivotal trials (GEMI1 expand
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). SUBSTUDY: ToleDYNAMIC substudy Type: Interventional Start Date: Apr 2024 |
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and F1
Amgen
Thyroid Eye Disease
The study consists of a randomized double-masked, placebo-controlled, parallel-group,
multicenter trial with an optional open-label treatment period for proptosis
non-responders who complete the Double-masked Treatment Period. expand
The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period. Type: Interventional Start Date: Jul 2024 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine The1
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with es1 expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Aug 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modul1
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low f1 expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
MFOLFIRINOX Versus MFOLFOX with or Without Nivolumab for the Treatment of Advanced, Unresectable, o1
Alliance for Clinical Trials in Oncology
Advanced Esophageal Adenocarcinoma
Advanced Gastric Adenocarcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Clinical Stage III Esophageal Adenocarcinoma AJCC V8
Clinical Stage III Gastric Cancer AJCC V8
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium,
oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium,
and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2
negative esophageal, gastroesophag1 expand
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers. Type: Interventional Start Date: Jan 2023 |
Oral Ifetroban in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Cumberland Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic,
radiation). The safety and efficacy of oral ifetroban will be assessed in patients with
IPF. expand
Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic, radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF. Type: Interventional Start Date: Jan 2024 |
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal1
Janssen Research & Development, LLC
Carcinoma, Non-small-Cell Lung
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts
except Cohort 4) and to characteriz1 expand
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Type: Interventional Start Date: Nov 2022 |
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Janssen Research & Development, LLC
Myasthenia Gravis
The purpose of this study is to determine the effect of nipocalimab on total serum
immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age
(globally) and 8 to <18 years of age (for Unites Stated (US) sites only), the safety and
tolerability of treatment with nipocalimab1 expand
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age (globally) and 8 to <18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy. Type: Interventional Start Date: Jul 2022 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multip1
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) expand
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Type: Interventional Start Date: Dec 2021 |
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to1
CG Oncology, Inc.
Non Muscle Invasive Bladder Cancer
High-grade Ta/ T1 Papillary Disease Bladder Cancer
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene
patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS
bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled
under the original protocol through Amendm1 expand
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment. Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1 papillary bladder cancer. Under Amendment 6, the target number of patients enrolled in Cohort P was increased to 75. Cohort P is open to enrollment Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to fail prior BCG therapy which is defined as having persistent or recurrent disease within 12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG therapy for HGUC Type: Interventional Start Date: Oct 2020 |
Amplatzer Amulet LAAO vs. NOAC
Abbott Medical Devices
Atrial Fibrillation
Stroke
Bleeding
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA
occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for
ischemic stroke and who are recommended for long-term NOAC therapy.
The clinical investigation is a prospective, random1 expand
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion. Type: Interventional Start Date: Jul 2020 |
Effects of Tirzepatide on Blood, Imaging and Breast Tissue Biomarkers
University of Kansas Medical Center
Obesity
Breast Cancer Risk
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who
are using tirzepatide to achieve weight loss. expand
Evaluation of biomarkers for risk of developing breast cancer in women with obesity who are using tirzepatide to achieve weight loss. Type: Observational Start Date: Sep 2024 |
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation1
Mannkind Corporation
MAC Lung Disease
Treatment Refractory MAC Lung Disease
Mycobacterium Infections, Nontuberculous
This clinical trial is designed to compare the efficacy and safety of Clofazimine
Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) expand
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT) Type: Interventional Start Date: Sep 2024 |
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Livi1
Eli Lilly and Company
Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (CKD)
The main purpose of this study is to determine if retatrutide can significantly lower the
incidence of serious heart-related complications or prevent the worsening of kidney
function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and
Atherosclerotic Cardiovascular Disease an1 expand
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor. Type: Interventional Start Date: Apr 2024 |
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
Astellas Pharma Inc
Solid Tumor
Genes contain genetic code which tell the body which proteins to make. Some types of
cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are
looking for ways to stop the actions of abnormal proteins made from the mutated KRAS
gene. The so-called G12D mutation in the KRAS1 expand
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors. ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396. In this study, ASP4396 is being given to humans for the first time. People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments. The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396. This study will be in 2 parts. Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2. Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies. In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished. People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not. After treatment has finished, people in the study will be followed up for up to 45 weeks. Type: Interventional Start Date: Apr 2024 |
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular L1
National Cancer Institute (NCI)
Classic Follicular Lymphoma
Follicular Lymphoma With Unusual Cytological Features
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating
patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal
antibody. It binds to a protein called CD20, which is found on B cells (a type of white
blood cell) and some types of cancer1 expand
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden. Type: Interventional Start Date: Oct 2024 |
A Study of IBI363 in Subjects with Advanced Solid Malignancies
Innovent Biologics (Suzhou) Co. Ltd.
Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer
Renal Cell Cancer
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy,
safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory
solid malignancies. expand
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies. Type: Interventional Start Date: Apr 2024 |
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Vedanta Biosciences, Inc.
Clostridium Difficile
Clostridium Difficile Infections
Clostridium Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile Infection Recurrence
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the
Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who
receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are
identical for Stage 1 (recurrent CDI) and1 expand
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI). Type: Interventional Start Date: May 2024 |
A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metas1
AstraZeneca
Non-small Cell Lung Cancer
Colorectal Carcinoma
Pancreatic Ductal Adenocarcinoma
Endometrial Cancer
Solid Tumor, Adult
Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to
express an HLA-C*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid
tumors. expand
Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to express an HLA-C*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid tumors. Type: Interventional Start Date: Feb 2024 |
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Orchestra BioMed, Inc
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. expand
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. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
Incyte Corporation
Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety, tolerability, dose-limiting
toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s)
for expansion (RDE) of INCA033989 administered in participants with myeloproliferative
neoplasms. expand
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms. Type: Interventional Start Date: Dec 2023 |
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Com1
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
The phase III trial compares the effect of pembrolizumab to observation for the treatment
of patients with early-stage triple-negative breast cancer who achieved a pathologic
complete response after preoperative chemotherapy in combination with pembrolizumab.
Immunotherapy with monoclonal antibodie1 expand
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. Type: Interventional Start Date: Jun 2023 |
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Sever1
Ionis Pharmaceuticals, Inc.
Severe Hypertriglyceridemia
The purpose of this study is to evaluate the safety and tolerability of olezarsen in
participants with SHTG. expand
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG. Type: Interventional Start Date: Dec 2022 |
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