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A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory...
Pfizer
Myositis
The purpose of the study is to understand how the study medicine PF-06823859 works in
people with idiopathic inflammatory myopathies (DM and PM). These disorders cause
inflammation that weakens the muscles that are important for movement and may also cause
skin rash in people with DM.
This study... expand
The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: - Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater - Have active DM or active PM. - Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. - Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site. Type: Interventional Start Date: May 2023 |
Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with...
Boundless Bio
Non-small Cell Lung Cancer
Non-Small Cell Lung Adenocarcinoma
Non-Small Cell Squamous Lung Cancer
Head and Neck Squamous Cell Carcinoma
Esophageal Cancer
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule
inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx).
This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety
profile and identify the maximum tolerated... expand
BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies. Type: Interventional Start Date: Mar 2023 |
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone...
Bayer
Biochemically Recurrent Prostate Cancer
Researchers are looking for a better way to treat men at high-risk of biochemical
recurrence (BCR) of prostate cancer.
BCR means that in men who had prostate cancer and were treated by either surgery and/ or
radiation therapy, the blood level of a specific protein called PSA rises. PSA is a
marker... expand
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Type: Interventional Start Date: Apr 2023 |
Safety and Efficacy of NMD670 in Ambulatory Adult Patients With Type 3 Spinal Muscular Atrophy
NMD Pharma A/S
Spinal Muscular Atrophy
The purpose of this study is to evaluate the efficacy, safety, tolerability and
pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular
atrophy type 3 expand
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of NMD670 in the treatment of ambulatory adults with spinal muscular atrophy type 3 Type: Interventional Start Date: Sep 2023 |
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-...
Janssen Research & Development, LLC
Ischemic Stroke; Ischemic Attack, Transient
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the
risk of recurrent ischemic stroke. expand
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke. Type: Interventional Start Date: Feb 2023 |
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator)...
Merck Sharp & Dohme LLC
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic
obstructive pulmonary disease (COPD). The goal of the study is to learn if people who
take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take
placebo. expand
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo. Type: Interventional Start Date: Mar 2023 |
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Mirati Therapeutics Inc.
Advanced NSCLC
Metastatic Lung Cancer
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical
efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the
first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C
mutation expand
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation Type: Interventional Start Date: Nov 2022 |
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants...
Kite, A Gilead Company
High-risk Large B-cell Lymphoma (LBCL)
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel,
versus standard of care (SOC) in first-line therapy in participants with high-risk large
B-cell lymphoma. expand
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma. Type: Interventional Start Date: Feb 2023 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease...
University of Minnesota
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) developed... expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
Children's Oncology Group
B Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy
vs. standard chemotherapy alone in protecting the liver in patients with leukemia or
lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of
acute lymphoblastic leukemia (ALL),... expand
This phase III trial compares the effect of adding levocarnitine to standard chemotherapy vs. standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients. Type: Interventional Start Date: Aug 2023 |
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib...
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide
(CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and
dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM)
who received between 1 to 3 prior lines of therapy... expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 2022 |
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
AtriCure, Inc.
Ischemic Stroke
Systemic Embolism
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority
trial. The objective of this trial is to evaluate the effectiveness of left atrial
appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial
embolism in subjects undergoing cardiac... expand
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. Type: Interventional Start Date: Jan 2023 |
Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome
National Cancer Institute (NCI)
Colorectal Carcinoma
Lynch Syndrome
This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent
colon and other cancers in participants with Lynch syndrome. Each of the three injections
in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells.
Injecting these substances may cause... expand
This phase IIb trial tests whether Tri-Ad5 in combination with N-803 works to prevent colon and other cancers in participants with Lynch syndrome. Each of the three injections in Tri-Ad5 vaccine contain a different substance that is in precancer and cancer cells. Injecting these substances may cause the immune system to develop a defense against cancer that recognizes and destroys any precancer and cancer cells that produce these proteins in the future. N-803 may increase immune responses to other vaccines. Giving Tri-Ad5 in combination with immune enhancing N-803 may lower the chance of developing colon and other cancers in participants with Lynch syndrome. Type: Interventional Start Date: May 2023 |
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory...
Kite, A Gilead Company
Relapsed/Refractory Follicular Lymphoma
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel,
works in participants with relapsed/refractory follicular lymphoma expand
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma Type: Interventional Start Date: Sep 2022 |
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
Bristol-Myers Squibb
Colitis, Ulcerative
The purpose of this study is to explore the safety, efficacy, effects on quality of life
(QOL), and biomarker response of ozanimod in participants with moderate to severely
active ulcerative colitis (UC) in clinical practice. expand
The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice. Type: Interventional Start Date: Jan 2023 |
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With...
Iovance Biotherapeutics, Inc.
Unresectable Melanoma
Metastatic Melanoma
Stage III Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in
adult participants with unresectable or metastatic melanoma or advanced non-small-cell
lung cancer (NSCLC). expand
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC). Type: Interventional Start Date: Jul 2022 |
Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery
University of Kansas Medical Center
Foley Catheterization
Ambulation
The study aims to compare between early versus delayed urinary catheter removal the
impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery expand
The study aims to compare between early versus delayed urinary catheter removal the impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery Type: Interventional Start Date: Jun 2022 |
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Sanofi
Chronic Obstructive Pulmonary Disease
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism
of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former
and current smokers with COPD, aged 40 to 70 years.
This study consists of participants who have been on a standard-of-care... expand
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period Type: Interventional Start Date: May 2022 |
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants...
Novartis Pharmaceuticals
Lupus Nephritis
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.)
ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in
combination with SoC, in adult participants with active LN expand
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN Type: Interventional Start Date: Jul 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With...
Xencor, Inc.
Metastatic Castration-Resistant Prostate Cancer
This Phase 2 study will investigate the safety and clinical activity of vudalimab
(XmAb20717) alone or in combination with standard of care anticancer therapies in
patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed
on prior therapy. expand
This Phase 2 study will investigate the safety and clinical activity of vudalimab (XmAb20717) alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior therapy. Type: Interventional Start Date: Oct 2021 |
Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
University of Kansas Medical Center
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
To determine if use of Moses 2.0 results in improved ablation efficiency during holmium
laser vaporization of the prostate. To determine if use of Moses 2.0 results in less
char, improved visibility, and improved hemostasis in prostate vaporization. expand
To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization. Type: Interventional Start Date: Nov 2022 |
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Poseida Therapeutics, Inc.
Multiple Myeloma
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1
allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory
Multiple Myeloma (RRMM). expand
Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM). Type: Interventional Start Date: May 2022 |
Mitigating the Pro-inflammatory Phenotype of Obesity
University of Kansas Medical Center
Blood Pressure
Diabetes
Obesity
Insulin Resistance
Diuretics Drug Reactions
The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve
activity (SNA) inhibition (oral clonidine) will cause a significant reduction in
circulating blood concentrations and endothelial cell expression of inflammatory markers
(e.g., TNF-α, IL-6).
Our study is a... expand
The purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (SNA) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., TNF-α, IL-6). Our study is a prospective study using a randomized, double-blinded design to test 4 weeks of SNA blockade (oral clonidine) compared with a BP-lowering control condition (diuretic, hydrochlorothiazide) or a placebo. Type: Interventional Start Date: Jul 2021 |
Reversing Glucose and Lipid-mediated Vascular Dysfunction
University of Kansas Medical Center
Blood Pressure
Hypertension
The purpose of our study is to understand the extent to which the blood vessels are
affected by glucose and fat (lipids) in lean healthy adults and if these changes in the
blood vessels contribute to the development of high blood pressure. expand
The purpose of our study is to understand the extent to which the blood vessels are affected by glucose and fat (lipids) in lean healthy adults and if these changes in the blood vessels contribute to the development of high blood pressure. Type: Interventional Start Date: May 2022 |
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