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

AcTFirst: A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer

Date Added
April 17th, 2026
PRO Number
Pro00147118
Researcher
Kevin Becker

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is for patients who have been diagnosed with prostate cancer that is prostate-specific membrane antigen (PSMA)-positive and has spread despite treatment with another androgen receptor pathway inhibitor (ARPI). This study is testing an investigational drug called AAA817. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In this study, participants will be randomly assigned (like flipping a coin) to receive AAA817 alone, AAA817 with an androgen receptor pathway inhibitor (ARPI), or standard of care treatment. The primary purpose of this study is to determine whether AAA817, given alone or in combination with an ARPI, is safe and effective compared to standard of care treatments. This drug is given to participants as a radioligand therapy infusion. Participants in this study can expect to be in the study for up to 6.1 years, including two visits before starting treatment, visits every 4 weeks during treatment, and visits every 12 weeks during long-term follow-up for up to 5 years after treatment ends.. There will be a total of 9 patients enrolled locally.

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

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination with Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination with Darolutamide Versus Darolutamide Alone in Patients with Metastatic Hormone Sensitive Prostate Cancer

Date Added
April 17th, 2026
PRO Number
Pro00147949
Researcher
Kevin Becker

List of Studies

Keywords
Cancer, Men's Health, Prostate
Summary

This study is for patients who have been diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).This study is testing an investigational drug called Tulmimetostat, which will be given in combination with standard prostate cancer treatments: Darolutamide or Abiraterone. "Investigational" means that Tulmimetostat has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the safety and potential benefits of Tulmimetostat when given with Darolutamide or Abiraterone. The study will also evaluate whether adding Tulmimetostat can delay the progression of prostate cancer compared to treatment with Darolutamide alone. Participants will receive the study drug by mouth, along with standard androgen deprivation therapy (ADT). Those receiving abiraterone will also take a low-dose corticosteroid (prednisone or prednisolone) to help prevent side effects. Participants can expect to be in the study as long as they are benefiting from treatment or until the study ends. During the first 4 weeks, study visits will occur on Days 1, 2, 8, 15, and 22. Beginning with Cycle 2, participants will have visits on Day 1 of every 4-week cycle. At study visits, participants will undergo health assessments such as physical exams, blood and urine tests, heart monitoring (ECG), imaging scans (CT or MRI), and health questionnaires. Some participants may also have an optional biopsy. A total of 8 patients will be enrolled locally over the course of 32 months.

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

A Prospective, Randomized, Comparative Effectiveness Study Comparing Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma

Date Added
April 21st, 2026
PRO Number
Pro00150296
Researcher
Jella An

List of Studies

Keywords
Disease Prevention
Summary

This study compares two common laser treatments used to lower eye pressure in participants with glaucoma or high eye pressure. Both procedures, Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT), are established standard-of-care medical treatments. Participants are randomly assigned by a computer to receive one of these two lasers to compare efficacy and safety. To maintain clinical consistency, both eyes of each participant receive the same assigned laser treatment during a single visit. There are no additional research-only appointments required beyond standard clinical care. The study team reviews medical records from the participants' standard 3, 6, and 12-month clinical follow-up visits. This research aims to help clinicians understand which treatment is more effective or efficient for future use. Participation is entirely voluntary and does not impact the quality of medical care provided at the institution.

Institution
MUSC
Recruitment Contact
Muhammad Abrar Irfan
8439260040
irfan@musc.edu

A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)

Date Added
April 22nd, 2026
PRO Number
Pro00147284
Researcher
Stephen Savage

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is for patients who have been diagnosed with low grade, intermediate risk non-muscle invasive bladder cancer. It is testing an investigational drug called TYRA-300. "Investigational" means that the drug has not been approved by the United States Food and Drug Administration (FDA).

The purpose of the study is to see whether TYRA-300 can shrink or eliminate bladder tumors without surgery. Normally, standard care involves a surgery called transurethral resection of bladder tumor (TURBT), but in this study at least one tumor will remain in place to see if the study drug works. The study will also evaluate the genetics of the cancer to see if certain mutations or changes in proteins affect how the drug works.

TYRA-300 is taken by mouth once daily. The dose level will be assigned by the study doctor. Participants may be in the study for about 36 months, which includes a screening period (up to 28 days), a study treatment phase (with visits every 4 weeks and more frequent visits during the first 8 weeks), an end-of-treatment visit, a safety follow-up about 28 days later, and long-term follow-up every 12 weeks. There will be a total of 3 patients enrolled locally over the course of 12 months.

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

A phase 3, randomized, parallel, multicenter, double-blind, placebo-controlled study to investigate efficacy and safety of KP-001 in patients aged ≥2 years with common venousmalformations, common lymphatic malformations, or KTS/CLOVES syndrome

Date Added
May 5th, 2026
PRO Number
Pro00149432
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to measure the efficacy and safety of KP-001 compared to placebo in patients with common venous malformations (VM), common lymphatic malformations (LM), or KTS/CLOVES syndrome. This phase 3, double-blind, randomized, placebo-controlled, parallel-group study will take place at multiple sites across North America. Vascular malformations like VM, LM, and KTS/CLOVES syndrome are serious, rare diseases with significant unmet medical needs. The study includes a 24-week double-blind treatment period with either KP-001 or placebo, followed by an open-label phase where all patients receive KP-001 up to Week 52. Patients weighing 40 kg or more will receive 100 mg of KP-001 once daily after breakfast, while those weighing less than 40 kg will receive a reduced dose based on their body weight.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults with Alcohol Use Disorder

Date Added
May 5th, 2026
PRO Number
Pro00149840
Researcher
Lindsay Squeglia

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

This study is testing whether an investigational compound called oleoylethanolamide (OEA) may help reduce alcohol use in young adults with alcohol use disorder. Young adults ages 18-25 will be randomly assigned to receive either OEA (250mg per day) or a placebo for six weeks. Researchers will measure alcohol use, immune function, oral bacteria, and thinking and decision-making. Compensation is available for those who qualify.

Institution
MUSC
Recruitment Contact
Brittney Browning
843-608-0514
Brownibr@musc.edu

LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer

Date Added
May 8th, 2026
PRO Number
Pro00149650
Researcher
Kelly Hyland

List of Studies

Keywords
Cancer/Breast, Mental Health, Stage IV
Summary

LiveWell mBC is a group-based skills training program for women with metastatic breast cancer (mBC). The program teaches skills from dialectical behavioral therapy, an evidence-based psychotherapy, that have been adapted specifically to help women live as well as possible, with metastatic breast cancer. LiveWell mBC involves meeting with a small group of women with mBC plus two skills trainers 9 times total via telemedicine. Meetings include orientation plus 8 sessions learning and practicing skills including mindfulness, emotion regulation, distress tolerance and interpersonal effectiveness and they last 90 minutes each. We are interested in seeing whether the program can help women to balance their emotions and better manage distress (e.g., anxiety, sadness) and symptoms (e.g., fatigue, breathlessness, pain) that can be common when living with mBC.

Participants will be randomly assigned to one of two groups. They will have a 2 in 3 chance of being assigned to LiveWell mBC (experimental group) and a 1 in 3 chance of being assigned to Usual Care (control group). Women in the usual care group will continue to receive their standard oncology care. Participants in both groups will complete questionnaires four times total. Participants may be invited to participate in an exit interview about their experience. Participants will be compensated for completing questionnaires and the interview. For most people, participation will last approximately 4 months.

Institution
MUSC
Recruitment Contact
Kathryn Moody
843-792-9698
moodykat@musc.edu

A Study of Acute Alcohol Binge-Induced Gut Barrier Dysfunction and Upregulation of CYP2E1

Date Added
May 19th, 2026
PRO Number
Pro00150802
Researcher
Garth Swanson

List of Studies

Keywords
Alcohol, Liver, Stomach
Summary

A single weight based dose of alcohol will be given to approximate an alcohol binge (aiming to achieve a blood alcohol concentration of approximately 0.08%) to investigate downstream effects on intestinal permeability and changes in hepatic steatosis. Several studies have been performed in humans under similar conditions and looking at similar things. The PI, Dr. Garth Swanson, conducted one of these studies previously. Here, participants will be given a weight-based dose (2mL vodka per kg body weight) of alcohol, with assessment of intestinal permeability via urine collection over the 24 hours directly following alcohol consumption, assessment of changes in hepatic steatosis by evaluation with fibroscan before and after alcohol consumption, and blood markers of endotoxemia and related inflammatory markers after. The weight-based dosing of alcohol was chosen to reflect previous studies looking at the effects of a single episode of alcohol binge use, with the goal of achieving a blood alcohol concentration of approximately 0.08%, the lower limit of what is needed to be considered an acute alcohol binge.

Institution
MUSC
Recruitment Contact
Keaveny (Katy) Donovan
8437927974
donova@musc.edu

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Date Added
May 19th, 2026
PRO Number
Pro00151048
Researcher
Andrea Abbott

List of Studies


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

This study is for patients diagnosed with early-stage melanoma and are the age of 75 or older. The usual approach for patients who are not in a study is treatment with two surgical procedures, a wide local excision (WLE) plus a sentinel lymph node (SLN) biopsy, followed by immunotherapy. The purpose of this study is to find if performing the WLE alone is just as effective as the usual approach and if it leads to improvements in patients' overall well-being.

A wide local excision (A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue; this is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. Immunotherapy is a type of cancer treatment that uses your body's immune system to identify and attack cancer cells.

Patients may participate in this study for up to 5 years. Procedures include a surgical biopsy, surveys, and regular visits with your doctor including follow-up study visits or phone calls every 6 months. There will be about 428 people taking part in this study, approximately 39 participants will be enrolled at MUSC.

Risks include infection, scarring, and bleeding. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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



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