
Search Clinical Trials
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Randomized Controlled Trial Testing a Training Program About Section 504 of the Rehabilitation Act
Vanderbilt University
Students With Disabilities and/or Family Members With Students With Disabilities That Have a Section 504 Plan
The goal of this training program is to learn if the intervention (i.e., training
program) can improve access to Section 504 among students with disabilities and family
caregivers. If students with disabilities and/or family caregivers are educated and
empowered about Section 504, then there may be1 expand
The goal of this training program is to learn if the intervention (i.e., training program) can improve access to Section 504 among students with disabilities and family caregivers. If students with disabilities and/or family caregivers are educated and empowered about Section 504, then there may be improved access to higher-quality of Section 504 plans. We aim to answer the following question: Is the training program effective? If there is a comparison group: We (our research team) will compare the intervention group to a waitlist-control group to discern differences in advocacy, empowerment, and knowledge and, subsequently, higher quality Section 504 plans and greater access to services. Participants will: - Attend an online class for an hour and a half each week for 6 weeks - Complete a pre-survey - Complete a formative evaluation after each program session - Complete a summative evaluation after the entire advocacy program - Complete a post-survey after completing the advocacy program - Complete a follow-up survey - Submit a copy of their child's (or their) Section 504 plan after providing consent Type: Interventional Start Date: Jul 2026 |
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A Nanoscopic Second Look Into the Knee Joint
Angelina Vera MD
Meniscal Tears
The goal of this clinical trial is to look at how well different surgeries heal over time
in patients that have previously undergone arthroscopic knee interventions. These
procedures may include cartilage repair or grafting, meniscus repair or trimming,
ligament reconstruction, cartilage smoothing,1 expand
The goal of this clinical trial is to look at how well different surgeries heal over time in patients that have previously undergone arthroscopic knee interventions. These procedures may include cartilage repair or grafting, meniscus repair or trimming, ligament reconstruction, cartilage smoothing, and treatments such as amniotic tissue or platelet rich plasma (PRP). Using a very small camera called a nanoarthroscope, doctors will take a "second look" inside the knee after surgery to see how it has healed. These findings will be compared to patient-reported outcomes, such as pain and function scores, as well as images taken during the original surgery. The goal is to determine whether this second look provides useful information that can help guide recovery and future care. Type: Interventional Start Date: May 2026 |
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Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids
Children's Hospital of Philadelphia
Cardiac Arrest
Anxiety Depression
Family Support
This pilot randomized controlled trial (RCT) will test the feasibility and acceptability
of the informational intervention program, Heartsight, to reduce caregivers' uncertainty
experienced throughout their child's illness trajectory after cardiac arrest. The
investigator aims to enroll up to 30 ca1 expand
This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge. Type: Interventional Start Date: Jun 2026 |
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A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Bl1
TScan Therapeutics, Inc.
AML
MDS
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the
efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101)
administered following reduced-intensity conditioning (RIC) hematopoietic cell
transplantation (HCT) in participants with1 expand
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity conditioning (RIC) hematopoietic cell transplantation (HCT) in participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The study will compare TSC-101 plus standard of care (SOC) versus SOC alone in participants undergoing allogeneic peripheral blood stem cell transplantation from haploidentical or mismatched unrelated donors. Type: Interventional Start Date: Jun 2026 |
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Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonis1
Ohio State University
Obesity & Overweight
Diabetes (DM)
This study examines how adults who take a GLP-1 receptor agonist medication (such as
semaglutide [Ozempic, Wegovy, Rybelsus], liraglutide [Saxenda, Victoza], or tirzepatide
[Mounjaro, Zepbound]) perform resistance (strength) training before and after starting
their medication.
GLP-1 medications ar1 expand
This study examines how adults who take a GLP-1 receptor agonist medication (such as semaglutide [Ozempic, Wegovy, Rybelsus], liraglutide [Saxenda, Victoza], or tirzepatide [Mounjaro, Zepbound]) perform resistance (strength) training before and after starting their medication. GLP-1 medications are being prescribed more and more often to help people manage type 2 diabetes and lose weight. These medications work well, but a known side effect is that people can lose lean (muscle) tissue along with fat. Losing muscle can make it harder to move, do everyday tasks, and stay strong as we age. Resistance training, things like lifting weights, using resistance bands, or doing push-ups and squats, is the most effective way to keep and build muscle. Yet most adults in the United States do not meet the recommended amount of resistance training, and very little is known about the resistance training habits of people who take GLP-1 medications. The purpose of this research is to systematically collect information from adults using GLP-1 medications so we can better understand: how often they do resistance training before and after starting the medication; what their sessions look like (frequency, duration, intensity, muscle groups); whether their resistance training is linked to how strong they feel and how well they can carry out daily activities; and what makes resistance training easier or harder while on a GLP-1 medication. Findings will help doctors, dietitians, exercise professionals, and researchers design better guidance and interventions to protect muscle mass, physical function, and quality of life in people using GLP-1 medications. Who can join: Adults 18 years or older who are currently taking a GLP-1 receptor agonist medication for type 2 diabetes, overweight or obesity, or weight management, and who have been on the medication for at least three months at a stable dose. Participants must be able to read and respond to the survey in English. People who are pregnant or planning bariatric surgery within the next three months are not eligible. What participants will do: The study is a single, anonymous, online survey. Interested individuals click the survey link, review a short consent page, and indicate their willingness to participate. Eligible participants then answer questions about their background, current health, GLP-1 medication and dose, resistance training habits before and after starting the medication, self-reported strength and function, and things that make resistance training easier or harder. There are no in-person visits, no exercise tests, and no blood draws. How long it takes: About 10 minutes total, in one online session. There is no follow-up after the survey and no compensation is offered. Data privacy: The survey is anonymous. No names, email addresses, or IP addresses are collected or linked to responses. The survey runs on Qualtrics, a secure, institution-approved platform hosted on Ohio State University servers. The research team hopes to enroll up to 200-300 adults across the United States. Type: Observational [Patient Registry] Start Date: Jun 2026 |
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Superior Parietal iTBS for PD-MCI
Medical University of South Carolina
Parkinson Disease
Mild Cognitive Impairment
The goal of this study is to determine the whether a short-term, high-dose form of
non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a
promising and safe treatment for mild cognitive impairment in Parkinson's disease
(PD-MCI). expand
The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI). Type: Interventional Start Date: Aug 2026 |
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A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikera1
Abeona Therapeutics, Inc
Recessive Dystrophic Epidermolysis Bullosa
The goal of this observational study is to evaluate the long-term safety and wound
healing durability (up to 15 years) for participants with Recessive Dystrophic
Epidermolysis Bullosa (RDEB) who were treated with pz-cel. The main questions it aims to
answer are:
- The long-term safety profile o1 expand
The goal of this observational study is to evaluate the long-term safety and wound healing durability (up to 15 years) for participants with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who were treated with pz-cel. The main questions it aims to answer are: - The long-term safety profile of pz-cel. - The wound healing durability of pz-cel. - The occurrence of all malignancies after treatment with pz-cel, regardless of type or location, in individuals who received pz-cel treatment for RDEB in the post-marketing setting. Participants will then be followed annually up to 15 years post-treatment. Assessments will occur via remote data collection. If the participants provider determines an office visit is necessary after the first year, some of this data can be collected in person as well. Annual assessments will include, but are not limited to: - Review of Adverse Events (AEs), Serious Adverse Events (SAEs), hospitalizations, and any evidence of malignancies and potential retroviral infection - Wound-healing durability data collection via the modified Caregiver Global Impression of Change for Wound Healing - Any changes in concomitant medications and procedures. Type: Observational [Patient Registry] Start Date: Jul 2025 |
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AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in1
James J. Peters Veterans Affairs Medical Center
Spinal Cord Injuries (SCI)
Blood Pressure
Thermoregulation
Perfusion Index
The goal of this clinical trial is to determine if perfusion index (PI) can reliably
predict changes in systolic blood pressure (SBP) in persons with spinal cord injury (SCI)
during a cool temperature challenge. Participants with SCI can be 18-75 years of age,
male or female, neurological level of1 expand
The goal of this clinical trial is to determine if perfusion index (PI) can reliably predict changes in systolic blood pressure (SBP) in persons with spinal cord injury (SCI) during a cool temperature challenge. Participants with SCI can be 18-75 years of age, male or female, neurological level of injury C4-T12, ASIA Impairment Scale (AIS: A or B: motor complete) or gender and healthy age-matched able-bodied (AB) controls. The main question this study aims to answer is: can PI reliably predict change in SBP during a cool temperature challenge? We hypothesize that PI can be used as a biomarker of SBP in persons with SCI. Researchers will compare the relationship of 1) changes in PI and SBP and 2) relationship of changes in other vital signs to SBP, during the cool temperature challenge. The researchers aim to determine if PI can be used as a biomarker of SBP in persons with SCI during a cool temperature challenge (experimental group/arm). Able-bodied controls (control group/arm) will receive the same intervention (cool challenge) as the experimental group. During the study, participants will be asked to wear only shorts and a T-shirt so that their skin can be exposed to the warm and cool temperatures of the 2 rooms. We will put put on non-invasive sensors (taped or attached on the surface of your body) to measure PI, BP, and other vital signs. We will record these measurements while you are seated in a wheelchair for 10 minutes in a warm room and up to 90 minutes in a cool room. Type: Interventional Start Date: Jul 2026 |
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A Randomized Control Trial of Conversations Advancing Resilience and Empowerment (CARE) Intervention
University of Texas Rio Grande Valley
Quality of Life
Health Promotion
Blood Pressure Monitoring, Self
The investigators propose to implement and evaluate the effectiveness of the peer-led
CARE Intervention designed to mitigate health differences among rural and low-income
communities in Texas. This intervention leverages the expertise of Community Health
Workers (CHWs) to empower rural and low-inco1 expand
The investigators propose to implement and evaluate the effectiveness of the peer-led CARE Intervention designed to mitigate health differences among rural and low-income communities in Texas. This intervention leverages the expertise of Community Health Workers (CHWs) to empower rural and low-income communities, improving health outcomes through outreach, education, counseling, and social support. Type: Interventional Start Date: Jun 2026 |
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Digital Technology-Informed Stroke Rehabilitation
University of Utah
Stroke
The goal of this study is to determine the effects of lab and home-based technology
guidance during movement training post-stroke. The study will compare movement training
informed by lab-based technology to training delivered with technology at home. The main
questions it aims to answer are:
-1 expand
The goal of this study is to determine the effects of lab and home-based technology guidance during movement training post-stroke. The study will compare movement training informed by lab-based technology to training delivered with technology at home. The main questions it aims to answer are: - How well do lab and home-based technologies help individuals post-stroke improve their movement patterns? - Is there a difference in improvement between the in-lab and at-home training groups? - Which technologies lead to the most improvement? Type: Interventional Start Date: Jul 2026 |
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A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in1
Cincinnati Eye Institute, Southwest Ohio
Presumed Ocular Histoplasmosis
This study will evaluate the safety and effects, good or bad of faricimab (Vabysmo®), a
drug that is approved by the U.S. Food and Drug Administration (FDA) for other retinal
conditions, but its use is considered investigational when used specifically for
choroidal neovascularization (CNV) related1 expand
This study will evaluate the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S. Food and Drug Administration (FDA) for other retinal conditions, but its use is considered investigational when used specifically for choroidal neovascularization (CNV) related to presumed ocular histoplasmosis (POHS) Type: Interventional Start Date: Jul 2026 |
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A Study of MZE782 in Adults With PKU
Maze Therapeutics
Phenylketonuria (PKU)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782
in adults with Phenylketonuria (PKU). expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU). Type: Interventional Start Date: Jun 2026 |
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Digital and Plasma Biomarkers in Delirium
Scripps Health
Critical Illness
Delirium in the Intensive Care Unit
Sleep Quality
The goal of this observational study is to learn if there are potential digital and
plasma-based biomarkers that could help detect, predict, and prognosticate delirium in
older adult patients who are admitted to the intensive care unit (ICU). The main question
DELTA aims to answer is:
Can digital1 expand
The goal of this observational study is to learn if there are potential digital and plasma-based biomarkers that could help detect, predict, and prognosticate delirium in older adult patients who are admitted to the intensive care unit (ICU). The main question DELTA aims to answer is: Can digital biometrics predict and detect delirium in older adult ICU patients? Do biomarkers of neurodegeneration fluctuate in ICU patients in such a way that delrium could potentially be predicted? Participants admitted o the ICU will wear a digital device to collect biometric data and will have serial plasma samples collected during ICU admission and patients will be also assessed for delirium daily by study staff. Type: Observational Start Date: May 2026 |
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A Study of ARC-02 in B-cell NHL
Taiho Oncology, Inc.
B-cell Non Hodgkin Lymphoma
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic
(PD), and preliminary efficacy of ARC-02. expand
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02. Type: Interventional Start Date: Jun 2026 |
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Evaluating How Well Different Types of Light-sensitive Cells in the Eye Contribute to Its Focusing1
Rochester Institute of Technology
Monochromatic
L- and S-cone Modulation Only
L- and M-cone Modulation Only
M and S-cone Modulation Only
In this experiment, subjects will view shapes on a screen with varying colors and be
asked to focus their eyes on the shapes. The shapes will look as though they are jumping
to random distances away from the eye. As the subjects focus their eyes on the shapes,
the investigators will measure the foc1 expand
In this experiment, subjects will view shapes on a screen with varying colors and be asked to focus their eyes on the shapes. The shapes will look as though they are jumping to random distances away from the eye. As the subjects focus their eyes on the shapes, the investigators will measure the focus of their eyes using a device called a wavefront sensor. This device uses infrared light to measure the optical properties of the eye in real time. Our goal is to find out how well the eye focuses on different colors. Our broad goal is to better understand how the eye focuses because that process is a major part of having clear and good vision. Type: Interventional Start Date: Jul 2026 |
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A Study of a New PET Scanner in People With Cancer
Memorial Sloan Kettering Cancer Center
Non Small Cell Lung Carcinoma NSCLC
Head and Neck Cancer
Prostate Cancer
The researchers are doing this study to test the capabilities of a new total-body PET
scanner called the Biograph Vision Quadra. The researchers want to learn whether this
scanner can produce better PET/CT images and provide more useful imaging information than
standard PET/CT scanners. expand
The researchers are doing this study to test the capabilities of a new total-body PET scanner called the Biograph Vision Quadra. The researchers want to learn whether this scanner can produce better PET/CT images and provide more useful imaging information than standard PET/CT scanners. Type: Observational Start Date: Jun 2026 |
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Neonatal White Matter Injury Trial (WRAP)
Bridget LaMonica Ostrem, M.D., Ph.D.
White Matter Injury
Brain Injury, Fetus and Neonate
Neonatal Brain Injury
Periventricular Leukomalacia
Periventricular White Matter Abnormalities
The researchers are investigating a new treatment for white matter injury, which is a
common type of brain injury in premature babies. The drug, clemastine, is experimental.
This means that the drug is not approved by the Food and Drug Administration (FDA) for
the treatment of white matter injury.1 expand
The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental. This means that the drug is not approved by the Food and Drug Administration (FDA) for the treatment of white matter injury. The main purpose of this study is to learn whether clemastine is safe to give to infants with white matter injury. The researchers also want to understand how much clemastine gets into an infant's body when the medication is taken by mouth, and how long it stays in the body. Type: Interventional Start Date: Jul 2026 |
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Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pr1
University of Arizona
Hypertension Disorders in Pregnancy
Blood Pressure Measurement in Pregnancy
Inspiratory Strength Training (IST)
Pregnancy
This is an interventional study that will test whether a breathing exercise called
Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood
pressure during late pregnancy. The goal is to see if a home-based breathing training can
help prevent or reduce high blood pressure1 expand
This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks. Type: Interventional Start Date: Jun 2026 |
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Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
National Institute of Allergy and Infectious Diseases (NIAID)
Trisomy 8 Mosaicism
Trisomy 8 Associated Autoinflammatory Disease
Mucosal Ulcerations
Background:
Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body.
Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area;
skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers
want to conduct a nat1 expand
Background: Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natural history study to learn more about these symptoms and what causes them. Objective: To gather data and samples from people with and without the trisomy 8 mosaicism. Eligibility: People of any age with the trisomy 8 gene mosaicism. Their healthy relatives are also needed. Design: Affected participants will have visits every 1 to 2 years for 30 years at NIH. Each visit will take 1 to 5 days and may be in-person or remote. With remote visits, participants may have a video call with the study team and samples may be sent to researchers by mail. Participants may have these procedures: Physical exam, with blood tests. Tests of brain function and motor skills. Sensory tests. Researchers will see how participants respond to sensations such as pinpricks, heat, cold, and pressure. Magnetic resonance imaging (MRI) scan of the brain and/or spine. X-ray of the spine. Ultrasound test of heart function (echocardiogram). Tissues samples (biopsies) collected from the skin, inside of the mouth, and bone marrow. Swabs to collect cells from the mouth, skin, and vagina. Collection of blood, stool, urine, saliva, hair, and fingernail samples. X-rays, MRI, and heart tests will be done only once. Other procedures may be repeated at each visit. All tests and procedures are voluntary. Healthy relatives who enroll will have a baseline visit and then follow-up visits as needed. They will have a physical exam. The inside of their mouth may be swabbed. Samples of blood, stool, urine, and saliva may be taken. Type: Observational Start Date: Aug 2026 |
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Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Yarrow Bioscience, Inc.
Graves' Disease
This study is being conducted to look at the effect YB-101 has on thyroid function. This
study will also evaluate how safe and well tolerated YB-101 is and how it is distributed
through the body.
The study consists of a part 1, blinded treatment period, and a part 2 double-blinded
treatment period1 expand
This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body. The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2. Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period. Type: Interventional Start Date: Jun 2026 |
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MH-POWER for College Students on the Spectrum
University of Texas Rio Grande Valley
Autistic College Students With Anxiety, Depression, Stress
The purpose of this project is to determine the feasibility and preliminary efficacy of a
mental health skill-building and empowerment program (MH-POWER) for college students on
the autism spectrum facing stress, anxiety, and depression. The program, grounded in
cognitive behavioral therapy (CBT),1 expand
The purpose of this project is to determine the feasibility and preliminary efficacy of a mental health skill-building and empowerment program (MH-POWER) for college students on the autism spectrum facing stress, anxiety, and depression. The program, grounded in cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and habit formation, will be implemented through weekly sessions and daily practice over 8 weeks. To evaluate the program's preliminary efficacy, we will measure mental health symptoms at baseline, mid-point, post-intervention, and one-month follow-up. Positive outcomes could lead to scalable interventions. Type: Interventional Start Date: Jul 2026 |
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Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outco1
Vanderbilt University Medical Center
Duchenne Muscular Dystrophy (DMD)
Cardiomyopathy
Becker Muscular Dystrophy
Carrier of Duchenne Muscular Dystrophy
Dystrophin associated heart dysfunction is a leading cause of death in patients with
Duchenne and Becker Muscular dystrophy (DMD/BMD) and Duchenne and Becker muscular
dystrophy carriers (MDC); however, the evolution of heart dysfunction is not
well-understood. The central objectives of this proposa1 expand
Dystrophin associated heart dysfunction is a leading cause of death in patients with Duchenne and Becker Muscular dystrophy (DMD/BMD) and Duchenne and Becker muscular dystrophy carriers (MDC); however, the evolution of heart dysfunction is not well-understood. The central objectives of this proposal are to elucidate this evolution of heart dysfunction and identify measures from cardiac MRI images that can predict death or significant heart disease in patients with DMD/BMD/MDC. This study will create a large clinical and cardiac MRI registry of dystrophin associated heart dysfunction, will utilize advanced image analysis techniques, including deep learning neural networks, to comprehensively evaluate every patient, and will create a risk toolkit accessible to clinicians around the world; this proposal has the potential to improve the quality of life in patients with dystrophin associated heart dysfunction by allowing for earlier and more intensive therapy in patients with severe disease and by identifying surrogate outcome measures for use in therapeutic trials. Type: Observational [Patient Registry] Start Date: Jan 2025 |
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A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efg1
TG Therapeutics, Inc.
Myasthenia Gravis
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult
participants with MG responding to treatment with efgartigimod. expand
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod. Type: Interventional Start Date: Jul 2026 |
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A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
Janssen Research & Development, LLC
Healthy
The main purpose of this study is to assess the concentrations of nipocalimab
(pharmacokinetics [PK]) in the breast milk after administration of a single dose of
nipocalimab into the vein, in healthy lactating women. expand
The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women. Type: Interventional Start Date: Jun 2026 |
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A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the B1
Biogen
Healthy Volunteer
In this study, researchers will learn how the body processes a study drug called BIIB144.
This is a "first-in-human" study. This means that this study drug will be given to people
for the first very time in this study. These studies are important because they help
researchers learn about the safety1 expand
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups. The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. The main question researchers want to answer in this study is: How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug. Researchers will also learn more about: - How the body processes BIIB144 compared to placebo. This study will be done as follows: - Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center. - Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center. - This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise. - There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle. - Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling. - Each participant will be in the study for up to 44 weeks. Type: Interventional Start Date: Jul 2026 |