A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis

Date Added
April 16th, 2026
PRO Number
Pro00146912
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is an open-label, long-term study assessing the safety and efficacy of abrocitinib in participants aged 2 years and older with moderate-to-severe AD. It includes an extension cohort and a de novo cohort to meet regulatory requirements for a minimum of 300 participants exposed to 52 weeks of abrocitinib. Extension cohort participants must have completed 16 weeks of treatment in parent studies B7451023 or B7451030 and remain eligible. De novo cohort participants must be aged 6 to under 12 years at enrollment and not have participated in previous abrocitinib studies. Enrollment for the de novo cohort will begin after enrollment in Study B7451023 is complete. The study will have two periods lasting up to 2 years or until commercial availability, whichever comes first. All participants will receive abrocitinib oral suspension.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu

A Multi-Center Screening Study to Characterize the Prevalence of the KIT D816V Mutation in Patients with Suspected Clonal Mast Cell Disease

Date Added
April 15th, 2026
PRO Number
Pro00149043
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury

Date Added
April 15th, 2026
PRO Number
Pro00148577
Researcher
Nicolas Pope

List of Studies

Keywords
Critical Care
Summary

The purpose of this research is to look at the safety and tolerabilty of an experimental study drug called AZD4144 and its effect on Sepsis-Associated Acute Kidney Injury (SA-AKI). The main goal of this research is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu

COMPASS Ancillary NeuroDevelopmental Outcomes (CAN-DO)

Date Added
April 15th, 2026
PRO Number
Pro00148202
Researcher
Sinai Zyblewski

List of Studies


Keywords
Cardiovascular, Pediatrics
Summary

The main reason for this research study is for researchers to evaluate the relationship between congenital heart disease and development. Currently, there is not enough long-term information available to researchers to predict a child's development if they have been diagnosed with Ductal Dependent Pulmonary Blood Flow (DDPBF), a type of congenital heart disease.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8317
wakefies@musc.edu

PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY-STAGE PARKINSON'S DISEASE

Date Added
April 14th, 2026
PRO Number
Pro00149436
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Parkinsons
Summary

This research study is being done to see the effectiveness and safety of a new drug called prasinezumab as a possible treatment for Parkinson's Disease. It has not been approved by the Food and Drug Administration. Eligible participants will be randomly assigned to received either prasinezumab or placebo (an inactive substance) The drug or placebo is given as an intravenous infusion every 4 weeks. Participation in the study is expected to last approximately 3 years. There is a Screening period that will last up to six weeks and a study treatment period that can last 104 weeks. There are two options at the end of the study, 1. Safety follow-up 70 days after last dose or Option 2: Two years of Open label prasinezumab and safety follow-up 70 days after last dose. The Screening, Randomization and Treatment period, Year 1 is 19 visits and treatment period Year 2 is 17 visits. Each visit will last to 4 to 6 hours. The OLE Year 1 is 16 visits and OLE Year 2 is 15 visits, and each visit will last 4 to 6 hours.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
8437921115
bulgarino@musc.edu

NRG-CC005, FORTE (Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps) (NCT05080673)

Date Added
April 10th, 2026
PRO Number
Pro00150494
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Gastrointestinal, Colonoscopy
Summary

This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Institution
MUSC
Recruitment Contact
Amy Thompson
(843) 522-5769
amy.thompson@bmhsc.org

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



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