Search Clinical Trials
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Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Sanofi
Amyotrophic Lateral Sclerosis
This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy,
safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in
male and female participants,18 to 80 years of age with ALS followed by an open label,... expand
This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants,18 to 80 years of age with ALS followed by an open label, longterm extension period. Study ACT16970 consists of 2 parts (A and B) as follows: Part A is a 24week, double blind, placebo controlled part, preceded by a screening period of up to 4 weeks before Day 1. On Day 1 of Part A, participants will be randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below: Treatment arm: SAR443820, BID Placebo arm: Placebo, BID Randomization will be stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), use of edaravone (yes vs no) and use of the combination of sodium phenylbutyrate and taurursodiol (named Relyvrio in the United States of America [USA] and Albrioza in Canada) (yes vs no). Participants will attend in clinic study assessments at baseline (Day 1), Week 2, Week 4, Week 8, Week 16, and Week 24, and will receive a phone call at Week 12 and Week 20. All ongoing participants in Part A will rollover to part B. The Week 24 Visit is the end of Part A and the beginning of Part B. Part B is an open label, longterm extension period that starts from the end of Part A (Week 24) and continues up to Week 106. The objectives of Part B are to further determine the safety and efficacy of longterm SAR443820 treatment. The treatment assignment of participants in Part A will remain blinded to Investigators, participants, and site personnel until the end of Part B. Every participant, except those who discontinued Investigational Medicinal Product (IMP) treatment permanently in Part A , will receive BID oral tablets of SAR443820 in Part B. Type: Interventional Start Date: Apr 2022 |
BIVV020 in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Sanofi
Transplant Rejection
Primary Objectives:
- Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
- Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR
Secondary Objectives:
- To assess the overall efficacy of BIVV020 in prevention or treatment... expand
Primary Objectives: - Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR - Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: - To assess the overall efficacy of BIVV020 in prevention or treatment of AMR - To characterize the safety and tolerability of BIVV020 in kidney transplant participants - To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants - To evaluate the immunogenicity of BIVV020 Type: Interventional Start Date: Jun 2022 |
A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
Abcuro, Inc.
Inclusion Body Myositis
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine
the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
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A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis Type: Interventional Start Date: Feb 2023 |
WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
Werewolf Therapeutics, Inc.
Advanced or Metastatic Solid Tumors
Non-Hodgkin Lymphoma
A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a
monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.
expand
A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Type: Interventional Start Date: Dec 2022 |
Virtual Reality for Pain in Acute Orthopedic Injuries
Massachusetts General Hospital
Injuries
Injury Arm
Injury;Sports
Injury, Knee
Injury Wrist
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute
orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain
mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute... expand
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury. Type: Interventional Start Date: Oct 2022 |
Designing an Implementation Strategy for Lung Screening and Smoking Cessation Treatment in Community...
Massachusetts General Hospital
Smoking Cessation
Tobacco use is the leading preventable cause of death in the US and a major driver of health
disparities. Among our tools for reducing the harms of tobacco is lung cancer screening
(LCS). This study will combine a review of existing qualitative and quantitative data on
barriers... expand
Tobacco use is the leading preventable cause of death in the US and a major driver of health disparities. Among our tools for reducing the harms of tobacco is lung cancer screening (LCS). This study will combine a review of existing qualitative and quantitative data on barriers to lung cancer screening and smoking cessation in underserved populations, a quantitative analysis of predictors of lung cancer screening and smoking cessation treatment use among Massachusetts Federally Qualified Health Centers (FQHC)s, and a stakeholder advisory group to synthesize these data and select implementation strategies that reflects the critical determinants and the strengths and resource constraints of the Federally Qualified Health Centers (FQHC) context. Type: Interventional Start Date: Dec 2022 |
Collagen-targeted PET Imaging for Early Interstitial Lung Disease
Massachusetts General Hospital
Interstitial Lung Disease
The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen
deposition in early interstitial lung disease.
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The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease. Type: Interventional Start Date: Sep 2022 |
Peripheral Neuroimmune Mechanisms of Hyperthermia
Massachusetts General Hospital
Hyperthermia
Major Depressive Disorder
Inflammation
The goal of this study is to examine how whole-body hyperthermia affects the
thermoinflammatory profile, which includes the combined immune and heat shock response, in
patients with depression and whether these changes correlate with decreased depression in
individuals with... expand
The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder. Type: Interventional Start Date: Nov 2022 |
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple...
Janssen Scientific Affairs, LLC
Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of cilta-cel
out-of-specification (OOS).
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The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS). Type: Interventional Start Date: May 2022 |
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants...
Arcus Biosciences, Inc.
Gastrointestinal Tract Malignancies
This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety
and preliminary clinical activity of treatment combinations with and without chemotherapy in
participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal... expand
This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Type: Interventional Start Date: Jun 2022 |
A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded...
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
The main purpose of this study is to learn more about the safety, side effects, and
effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a
particular gene (known as the RET gene). Participation could last up to 24 months (2 years)
and possibly... expand
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a particular gene (known as the RET gene). Participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse. Type: Interventional Start Date: Mar 2022 |
Prostate Cancer Genetic Risk Evaluation and Screening Study
Massachusetts General Hospital
Prostatic Neoplasm
Prostate Cancer
BRCA2 Mutation
BRCA1 Mutation
ATM Gene Mutation
This study aims to define the natural history of men at high genetic risk for prostate cancer
on the basis of specific germline genetic mutations or a positive family history and evaluate
the utility of prostate MRI as a screening tool. The hypothesis is that this targeted... expand
This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations or a positive family history and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations. Type: Observational [Patient Registry] Start Date: Feb 2020 |
Biomarker Development for Muscular Dystrophies
Massachusetts General Hospital
Myotonic Dystrophy
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Facioscapulohumeral Muscular Dystrophy
Current methods of measuring the response to new treatments for muscular dystrophies involve
the examination of small pieces of muscle tissue called biopsies. The investigators are
interested in finding less invasive methods that reduce the need for muscle biopsies. The
purpose... expand
Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample, and some muscles in the arms and legs using tests called ultrasound and electrical impedance myography; both tests are painless and non-invasive. The information that is gathered from this study may help to evaluate, prevent, diagnose, treat, and improve the understanding of human muscle diseases. Type: Observational Start Date: Feb 2015 |
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
National Institute of Allergy and Infectious Diseases (NIAID)
Rheumatoid Arthritis (RA)
Systemic Lupus Erythematosus (SLE)
Pemphigus Vulgaris
Multiple Sclerosis (MS)
Systemic Sclerosis (SSc)
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune
response to different additional doses of COVID-19 vaccine in participants with autoimmune
disease requiring IS medications. All study participants will have negative serologic or
suboptimal... expand
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM) Type: Interventional Start Date: Aug 2021 |
A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor
Children's Oncology Group
Brain Neoplasm
Recurrent Brain Neoplasm
This phase III trial compares memantine to usual treatment in treating patients with brain
tumors that are newly diagnosed or have come back (recurrent). Memantine may block receptors
(parts of nerve cells) in the brain known to contribute to a decline in cognitive function.... expand
This phase III trial compares memantine to usual treatment in treating patients with brain tumors that are newly diagnosed or have come back (recurrent). Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary brain tumor. Type: Interventional Start Date: Nov 2021 |
Safety Study of Inhaled Carbon Monoxide to Treat Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)
Brigham and Women's Hospital
Acute Respiratory Distress Syndrome
Sepsis
This study is a multi-center, randomized, partially double-blind, and placebo-controlled
Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute
respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and
accuracy... expand
This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a target carboxyhemoglobin (COHb) level of 6-8% in patients with sepsis-induced ARDS. We will also examine the biologic readouts of low dose iCO therapy in patients with sepsis-induced ARDS. Type: Interventional Start Date: Mar 2023 |
Phase 1a and Phase 2 Study for PK, PD, Safety and Preliminary Efficacy of ST-067
Simcha IL-18, Inc.
Cancer
Solid Tumor
Melanoma
Renal Cell Carcinoma
Triple-negative Breast Cancer
This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of
ST-067. Phase 1a is a first-in-human (FIH) dose escalation study in patients aged 18 years or
older diagnosed with solid tumors who have exhausted available standard. Phase 2 will enroll... expand
This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067. Phase 1a is a first-in-human (FIH) dose escalation study in patients aged 18 years or older diagnosed with solid tumors who have exhausted available standard. Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and microsatellite instability-high tumors. Type: Interventional Start Date: Aug 2021 |
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902),...
Merck Sharp & Dohme LLC
Carcinoma, Renal Cell
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus
belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab
plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell
carcinoma... expand
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. Type: Interventional Start Date: Apr 2021 |
Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid...
Sanofi
Breast Cancer Metastatic
Pancreatic Carcinoma Metastatic
Primary Objective:
- For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of
tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine
monotherapy and in combination with gemcitabine in metastatic pancreatic... expand
Primary Objective: - For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) - For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: - To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess the immunogenicity of tusamitamab ravtansine - To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination Type: Interventional Start Date: Mar 2021 |
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell...
Janssen Research & Development, LLC
Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to
placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult
participants with new-onset or relapsing giant cell arteritis (GCA).
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The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA). Type: Interventional Start Date: Dec 2020 |
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults...
Hoffmann-La Roche
Multiple Sclerosis
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate
efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV)
infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose... expand
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab. Type: Interventional Start Date: Dec 2020 |
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Pfizer
Neoplasm Metastasis
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as
Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
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A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors Type: Interventional Start Date: Sep 2020 |
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Immunocore Ltd
Select Advanced Solid Tumors
IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®)
designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This
is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult
patients... expand
IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME Type: Interventional Start Date: Feb 2020 |
KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475)...
Merck Sharp & Dohme LLC
Carcinoma, Non-Small-Cell Lung
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in
the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master
protocol uses a platform design and consists of this master screening study and three
substudies.... expand
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and three substudies. Each substudy will enroll a different population of NSCLC participants. The goal of this umbrella master protocol is to screen potential participants with NSCLC for enrollment into 1 of 3 substudies. Participants must first enroll in this pembrolizumab master protocol study and undergo screening for NSCLC that will be used to assign them to participation in 1 of 3 pembrolizumab substudies. Type: Observational Start Date: Dec 2019 |
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard...
AbbVie
Acute Myeloid Leukemia (AML)
Cancer
The main objective of this study is to evaluate the efficacy of venetoclax in combination
with azacitidine to improve Relapse Free Survival (RFS) in Acute Myeloid Leukemia (AML)
participants compared to Best Supportive Care (BSC) when given as maintenance therapy
following... expand
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B). Type: Interventional Start Date: Feb 2020 |
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