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A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone1
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Biogen
Relapsing Forms of Multiple Sclerosis
In this study, researchers will learn more about a study drug called BIIB091 in
participants with MS who may be experiencing relapses. It is a 2-part study.
In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF).
In Part 2, a different set of participants will take1 expand
In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, a different set of participants will take either a combination of BIIB091 and DRF or DRF alone. The goal of the study is to learn more about the safety of BIIB091 and to compare the effects of the study drug when taken alone or together with DRF. The main question researchers are trying to answer are: - How many participants have new or worsening medical problems (adverse events) after taking BIIB091 or DRF? - How many new areas of inflammation occur in the brain after treatment with BIIB091 and DRF? Researchers will use magnetic resonance imaging (MRI) scans to compare images of the brain before and after treatment. They will also explore the effect of BIIB091 and DRF on the heart using electrocardiograms (ECGs). The study will be done as follows: - After screening, participants who joined Part 1 will be randomly assigned to receive either a high or low dose of BIIB091, or the standard dose of DRF. - The results of Part 1 will be used to choose the best dose of BIIB091 to use in Part 2. - Participants who join Part 2 will be randomly assigned to receive either a standard dose of DRF, a combo of BIIB091 and the standard dose of DRF, or a combo of BIIB91 with a low dose of DRF. - Neither the researchers nor the participants will know which drug or dose the participants will receive in either part of the study. - The treatment period will last 48 weeks in each part of the study. Participants will take the drugs by mouth 2 times a day. - Each part will also have a follow-up safety period that lasts up to 2 weeks. - In total, participants in each part will have 20 study visits, or more if they have a relapse. The total study duration for participants will be up to 54 weeks. Type: Interventional Start Date: Jul 2023 |
More and Less Social Comprehension
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University of Kansas Medical Center
Autism Spectrum Disorder
The goal of this early Phase 1 clinical trial is to assess if the social content of a
story impacts autistic children's listening comprehension of stories. The main questions
this study aims to answer are:
- Does removing social content from a story improve listening comprehension in
autis1 expand
The goal of this early Phase 1 clinical trial is to assess if the social content of a story impacts autistic children's listening comprehension of stories. The main questions this study aims to answer are: - Does removing social content from a story improve listening comprehension in autistic children? - Does listening comprehension of more social versus less social stories differentially predict performance on a standardized reading comprehension measure? Participants will listen to more social and less social stories while viewing accompanying pictures and answer comprehension questions about the stories and complete a standardized assessment of reading comprehension. In addition, participants complete measures of their nonverbal cognition, hearing status, autism severity, language abilities, and social communication abilities to help characterize individual differences in participants. Type: Interventional Start Date: Jul 2023 |
American Lung Association (ALA) Lung Health Cohort
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Johns Hopkins University
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately
4,000 young adults between the ages of 25-35 who do not have severe lung disease. The
overarching objective of the ALA-LHC is to establish a national cohort of young adults
for the purpose of defining lung healt1 expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
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James P. Rathmell, MD
Painful Diabetic Neuropathy
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain
Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction
Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful
Diabetic Peripheral Neuropathy (PDPN) in a pla1 expand
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol. Type: Interventional Start Date: Sep 2022 |
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Frontier Medicines Corporation
Advanced Solid Tumors With KRAS G12C Mutations
Solid Tumor, Adult
Unresectable Solid Tumor
Metastatic Solid Tumor
Non Small Cell Lung Cancer
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced
solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts:
Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion).
Multiple dose levels in participants w1 expand
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated. Type: Interventional Start Date: Feb 2024 |
Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities
University of Kansas Medical Center
Intellectual Disability
Overweight and Obesity
The goal of this study is to see if adding hands-on cooking classes to a weight
management program (called Chef-ID) helps young adults with intellectual disabilities
lose more weight and keep it off compared to a standard weight loss program. The study
will last 24 months and include three phases:1 expand
The goal of this study is to see if adding hands-on cooking classes to a weight management program (called Chef-ID) helps young adults with intellectual disabilities lose more weight and keep it off compared to a standard weight loss program. The study will last 24 months and include three phases: 6 months of active support, 12 months of maintenance, and 6 months with no contact. The investigators will look at how much weight participants lose over the first 18 months. Changes in cooking skills, body fat, health markers (like blood pressure and cholesterol), daily living skills, and caregiver stress will be tracked. Finally, factors that might help or prevent weight loss, and how changes in weight and body fat are linked to overall health will be explored. This research will help inform on how to better support healthy lifestyles for people with intellectual disabilities. Type: Interventional Start Date: Jun 2025 |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 i1
Apogee Therapeutics, Inc.
Asthma
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
safety, tolerability, PK, and immunogenicity of APG777 in adult participants with
mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant
and will con1 expand
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma. The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period. Type: Interventional Start Date: Mar 2025 |
53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild1
OrthoTrophix, Inc
Osteoarthritis (OA) of the Knee
53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of
TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the
Knee expand
53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the Knee Type: Interventional Start Date: May 2025 |
A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease
TrueBinding, Inc.
Parkinson's Disease (PD)
The primary objectives of this study are to assess the efficacy of TB006 in improving
motor function and to assess the safety of TB006 in participants with Parkinson's Disease
(PD). expand
The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD). Type: Interventional Start Date: Mar 2025 |
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis1
Novartis Pharmaceuticals
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 followe1 expand
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). Type: Interventional Start Date: Oct 2024 |
A Study of Mosliciguat in PH-ILD
Pulmovant, Inc.
Pulmonary Hypertension
Interstitial Lung Disease
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical
study to evaluate the safety and efficacy of inhaled mosliciguat in participants with
pulmonary hypertension associated with interstitial lung disease (PH-ILD). expand
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Type: Interventional Start Date: Oct 2024 |
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non1
Alliance for Clinical Trials in Oncology
Resectable Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
This phase III trial compares standard therapy given after surgery (adjuvant) to standard
therapy given before and after surgery (perioperative) in treating patients with stage
II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable).
The usual approach for patients wi1 expand
This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC. Type: Interventional Start Date: Dec 2024 |
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
Deciphera Pharmaceuticals, LLC
Chronic Graft-Versus-Host Disease (cGVHD)
The purpose of this study is to determine if vimseltinib is safe, tolerable and works
effectively to treat adults with active moderate to severe cGVHD. Participants will be
treated with vimseltinib in 28-day treatment cycles for approximately 2 years. expand
The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years. Type: Interventional Start Date: Nov 2024 |
A Study of BG-C477 in Participants With Advanced Solid Tumors
BeiGene
Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,
pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination
with anticancer agents in participants with selected advanced solid tumors. expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors. Type: Interventional Start Date: Oct 2024 |
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Allogene Therapeutics
Large B-cell Lymphoma
This is a randomized, open-label study in adult patients who have completed standard
first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or
partial response suitable for observation, but who have minimal residual disease (MRD) as
detected by the Foresight CLARITY™ I1 expand
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation. Type: Interventional Start Date: Jun 2024 |
A Study of SGN-MesoC2 in Advanced Solid Tumors
Seagen, a wholly owned subsidiary of Pfizer
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Pancreatic Adenocarcinoma
Colorectal Neoplasms
Mesothelioma
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that
start in a part of your body like your lungs or liver instead of your blood. Once tumors
have grown bigger in one place but haven't spread, they're called locally advanced. If
your cancer has spread to other parts1 expand
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08052666/SGN-MesoC2. PF-08052666/SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will have 3 parts. Part A and Part B of the study will find out how much PF-08052666/SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if PF-08052666/SGN-MesoC2 is safe and if it works to treat solid tumor cancers. Type: Interventional Start Date: Aug 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 |
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized1
Cabaletta Bio
Generalized Myasthenia Gravis (gMG)
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Participants with Generalized Myasthenia Gravis expand
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis Type: Interventional Start Date: Dec 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 |
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTL1
Replimune Inc.
Advanced Melanoma
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study
comparing VO in combination with nivolumab versus Physician's Choice treatment for
patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on
an anti PD-1 and an anti-CTLA-4 containing regi1 expand
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy. Type: Interventional Start Date: Jul 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 |
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Curium US LLC
Prostate Cancer
Prostate Adenocarcinoma
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T
injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate
high-risk, high-risk or very high-risk prostate cancer. expand
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer. Type: Interventional Start Date: Apr 2024 |
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a H1
Novo Nordisk A/S
Cardiovascular Risk
Acute Myocardial Infarction (AMI)
The research study is being done to see if ziltivekimab can be used to treat people who
were admitted to hospital because of a heart attack. Ziltivekimab might reduce
development of heart disease, thereby preventing new heart attacks or strokes.
Participants will either get ziltivekimab (active med1 expand
The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years. Type: Interventional Start Date: Jun 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 |
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