The Impact of Toxic Exposures on Vascular Autoantibodies in Lupus Associated Cardiovascular Disease

Date Added
April 10th, 2026
PRO Number
Pro00147299
Researcher
Helen Butler

List of Studies

Keywords
Cardiovascular, Lupus
Summary

The purpose of this study is to understand how exposure to harmful substances during military service may affect the health of Veterans with or without lupus. Lupus is an autoimmune disease that can increase the risk of cardiovascular problems.

We believe that Veterans who were exposed to toxic substances during their military service may develop more harmful antibodies that attack the lining of their blood vessels. These antibodies may contribute to poorer blood vessel and heart health, and could contribute to the development of lupus.

This study aims to improve our understanding of how toxic military exposures may increase the risk of blood vessel complications in Veterans with and without lupus. Ultimately, this research may help identify new ways to better prevent, monitor, or treat cardiovascular disease in this population.

Research procedures for this study will include:

1. The study team will check subject medical records to gather information about medical history and medications being taking. The study team may continue to follow updates in the medical record.
2. Subjects will be given a survey to assess military and occupational toxic inhalant exposures.
3. Subjects will have a brief physical examination during which vitals will be recorded (height, weight, heart rate, respiration, temperature). Women of childbearing ages will be asked for the date of their last menstrual cycle within the past 2 months.
4. Subjects will have blood pressure taken three times three minutes apart.
5. Subjects will then provide a urine sample. Urine collection will occur in a private restroom using a sterile container provided by the study team. For women of childbearing ages, a pregnancy dipstick test will be undertaken on urine to confirm subjects are not pregnant.
6. Subjects will undergo a blood draw where approximately 4 teaspoons of blood will be drawn.

Institution
MUSC
Recruitment Contact
Helen Butler
7046540686
butlehel@musc.edu

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Date Added
April 9th, 2026
PRO Number
Pro00149264
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Zasocitinib (TAK-279) is an oral TYK2 inhibitor being studied as a potential treatment for moderate-to-severe plaque psoriasis in children and adolescents, a group with limited safe and effective oral options. TYK2 plays a crucial role in immune pathways involved in psoriasis, especially through IL-23's activation of Th17 cells and production of proinflammatory cytokines. Current treatments include injectable biologics and the oral agent apremilast, but few oral therapies match the efficacy of biologics. In phase 2b trials, zasocitinib showed promising results, with over two-thirds of adult participants achieving PASI-75 at certain doses by week 12 and no major safety concerns. Ongoing phase 3 trials are evaluating zasocitinib as a potential new oral treatment for pediatric plaque psoriasis.

Institution
MUSC
Recruitment Contact
Chadrick Schwipper
843-876-3209
schwippe@musc.edu

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy

Date Added
April 9th, 2026
PRO Number
Pro00149086
Researcher
Anthony Dominick

List of Studies

Keywords
Cancer
Summary

This is a Phase 3 randomized study to compare two new drug combinations of teclistamab with daratumumab and lenalidomide and talquetamab with daratumumab and lenalidomide versus standard of care in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. The study is expected to continue for approximately 9 years.The Medical University plans to enroll 12 participants. The duration of participation will depend on the response of the study treatment. Subjects will receive treatment weekly or every 2 weeks. Medical history and physical examination, including lab tests like blood work and imaging, as well as questionnaires will be completed. Known risks include Cytokine Release Syndrome (CRS) as a complication that can happen due to the activation of immune cells.

Institution
MUSC
Recruitment Contact
Thomas Hortman
8437929300
hortman@musc.edu

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

Date Added
April 9th, 2026
PRO Number
Pro00149000
Researcher
Charlie Strange

List of Studies


Keywords
Drug Studies, Liver, Lung, Pulmonary, Rare Diseases
Summary

This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.

The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD

Date Added
April 7th, 2026
PRO Number
Pro00149990
Researcher
Sarah Miller

List of Studies


Keywords
COPD
Summary

Chronic obstructive pulmonary disease (COPD) is a leading cause of death and decreased quality of life, particularly among individuals living in rural areas. This project will test a home-based, technology-supported respiratory muscle training program designed to reduce shortness of breath and improve daily functioning and quality of life in adults with COPD. Findings from this research will support development of scalable approaches to improve respiratory health for individuals with COPD living in rural communities.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-259-4689
pittmama@musc.edu

Longitudinal assessment of age-related swallowing changes and potential biological correlates

Date Added
April 7th, 2026
PRO Number
Pro00149182
Researcher
Janina Wilmskoetter

List of Studies


Keywords
Aging, Disease Prevention, Healthy Volunteer Studies
Summary

This study will examine the factors that contribute to changes in swallowing as people age. Over the next ten years, researchers will follow healthy adults (age 18 and older) to see if swallowing becomes more difficult with age. They will also look at whether changes in the brain, thinking skills, and body chemistry are connected to swallowing problems. The information from this study may help doctors find ways to address problems such as choking or aspiration pneumonia in older adults.

Participants can change their mind and stop participating at any time, for any reason. Leaving the study will not affect any benefits or care they are entitled to.

If you would like to learn more, please contact the study team.

Institution
MUSC
Recruitment Contact
Janina Wilmskoetter
843-548-1053
wilmskoe@musc.edu

Identifying Biobehavioral Predictors and Targeting Mechanisms of Intervention in Adolescent Posttraumatic Stress Disorder

Date Added
April 7th, 2026
PRO Number
Pro00149051
Researcher
Rachel Siciliano

List of Studies

Keywords
Adolescents, Mental Health, Stress Disorders
Summary

This study looks at how teens with trauma-related symptoms respond to stress and strong emotions. We will measure brain activity, body responses, and behavior during activities that involve reacting to possible threats, managing emotions, and imagining parts of their own stressful or traumatic experiences more than once.

The goal of this research is to better understand how repeating these imagining activities affects teens. We also want to learn whether a teen's reaction to stress and their ability to manage emotions are connected to how they respond to imagining stressful events.

What we learn may help improve treatments for posttraumatic stress disorder (PTSD) and help identify which teens are most likely to benefit from these treatments, based on brain, body, and behavior responses.

Institution
MUSC
Recruitment Contact
Rachel Siciliano
843-779-8833
siciliar@musc.edu

Abbott Cephea Mitral Valve Disease Registry

Date Added
April 6th, 2026
PRO Number
Pro00149421
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart
Summary

This study is seeking subjects who have been diagnosed with and may be receiving medical treatment for mitral valve disease. The purpose of this registry is to collect data to better understand the progression of mitral valve disease and the effects of different treatments on the disease and patient health. If you agree to participate in this registry, your medical data will be collected including your medical history, certain background information, and certain test images/results. This registry will also collect information about current and future treatments for your mitral valve disease and data from future disease-related follow-up visits. Data will be collected for up to 24 months. There are no additional visits or any additional testing required for this registry.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

Accelerating Translation to Practice: Multi-Level Interventions for Efficient Care Coordination Across Medical Specialties

Date Added
April 4th, 2026
PRO Number
Pro00150455
Researcher
Michelle Mollica

List of Studies


Keywords
Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Other, Non-interventional
Summary

This research study aims to improve care coordination in the context of cancer survivorship care by understanding how primary care providers and cancer specialists share responsibilities. Researchers want to understand how technology can help these teams communicate more clearly and effectively to coordinate care for survivors. The study team will use surveys and conduct interviews and focus groups for interested and eligible participants as methods of data collection to inform the research. Oncologists, primary care physicians, and survivors of breast, prostate, lung, colon and rectal cancer that meet the eligibility criteria will complete surveys and engage in interviews to understand barriers and identify strategies to improve care. Using this information, the team will create an intervention plan called ACT that addresses common barriers, using focus group discussions to refine the intervention. The ultimate goal is to help patients receive better and more coordinated follow‑up care.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-792-3512
pittmama@musc.edu

An Open-label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-label Vedolizumab Intravenous Therapy

Date Added
April 1st, 2026
PRO Number
Pro00148307
Researcher
Carmine Suppa

List of Studies

Keywords
Crohn's Disease, Pediatrics, Ulcerative colitis
Summary

Efficacy of the vedolizumab IV and SC formulations has been demonstrated in completed studies of adult subjects with moderately to severely active UC or CD. Clinical trial results are needed to affirm proper dosing, exposure, efficacy and safety for use of vedolizumab in pediatric patients. Subsequent to preliminary positive results from the completed pediatric phase 2, vedolizumab IV is being further evaluated in the phase 3 Studies MLN0002-3024 and MLN0002-3025 (subjects aged 2 to 17 years). Confirmatory positive results from these studies would support submission for registration of vedolizumab IV for pediatric patients. Vedolizumab SC is being evaluated in the proposed study to provide an alternative administration route of vedolizumab for maintenance treatment in the
same pediatric population

Institution
MUSC
Recruitment Contact
Trudy Spuller
843-792-0560
spuller@musc.edu



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