A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE

Date Added
September 16th, 2025
PRO Number
Pro00146400
Researcher
Stephen Stripling

List of Studies

Keywords
Children's Health, Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

This is a Phase 2, multicenter, randomized, partially double-blind study to evaluate the safety, tolerability, and immunogenicity of PG4 in healthy toddlers 12 through 15 months of age who previously received 3 infant doses of 20vPnC. This study will be conducted at investigator sites in the US and Puerto Rico. Approximately 225 children between 12 and 15 months of age will be enrolled and randomized in a 2:2:1 ratio by site-based randomization to receive either 1 or 2 doses of PG4 (90 participants per group) or 1 dose of the control vaccine 20vPnC (45 participants). The vaccine in toddlers randomized to receive 1 dose will be double-blind, as PG4 and 20vPnC have the same appearance and a single dose will be administered at Visit 101 of the study. For participants randomized to 2 doses of PG4, the parents/legal guardians and site staff will know that these participants will need to return for a second vaccination visit and that they will receive PG4 at both Visit 201 and Visit 202.

Institution
MUSC
Recruitment Contact
Meghan Armistead
8434736623
mea301@musc.edu

A randomized controlled trial of transcutaneous electrical nerve stimulation for pain mitigation during intrauterine device placement

Date Added
September 16th, 2025
PRO Number
Pro00143776
Researcher
Michelle Meglin

List of Studies


Keywords
Obstetrics and Gynecology
Summary

We are conducting this study to determine whether using a TENS (nerve stimulation) unit is effective at reducing pain in women having an IUD inserted.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

Islet Longitudinal Outcomes Database

Date Added
September 13th, 2025
PRO Number
Pro00141761
Researcher
Kevin Roggin

List of Studies

Keywords
Pancreas, Transplant
Summary

This study is a database evaluating data in patients with chronic pancreatitis that are seen and evaluated in a surgery clinic and ultimately under surgery for chronic pancreatitis with total pancreatectomy with islet cell transplant. Patients will receive the standard of care for this operation. This is not a clinical trial, and no changes will be made to their care. Data will be collected to review outcomes only. They may be asked to fill out study related questionnaires or surveys.

Institution
MUSC
Recruitment Contact
Megan Walters
843-792-9393
Tayloml@musc.edu

A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Date Added
September 12th, 2025
PRO Number
Pro00146131
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

This multicenter, randomized, placebo-controlled, double-blind study aims to evaluate the efficacy of anifrolumab subcutaneous (SC) injection compared to a placebo in reducing overall disease activity in participants with moderate to severe idiopathic inflammatory myopathies (IIM), specifically polymyositis (PM) and dermatomyositis (DM), while they receive standard care treatment.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-491
mcleodke@musc.edu

A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO‑CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

Date Added
September 12th, 2025
PRO Number
Pro00143084
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study aims to evaluate how effective and safe the 100 mg daily dose of ritlecitinib is for participants. By including the already approved 50 mg daily dose as a reference point, the study seeks to draw direct comparisons between these two dosages. This comparison will help determine if increasing the dosage offers additional benefits or poses any new risks. Participants in this study will be closely monitored to assess both their response to treatment and any potential side effects that may arise. The findings from this investigation are expected to provide valuable insights into optimizing ritlecitinib dosing regimens for better therapeutic outcomes.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

Feasibility and Acceptability of A Mobile Application "SUPPORT-T" to increase access to Palliative Care in patients with Progressive Pulmonary Fibrosis (PPF) and their Caregivers.

Date Added
September 10th, 2025
PRO Number
Pro00146761
Researcher
Kathleen Lindell

List of Studies

Keywords
Education, Interstitial Lung Disease (ILD)
Summary

The goal of this research study is to explore and evaluate the acceptability and feasibility of a 8-week, nurse-led Palliative Care program (SUPPORT-T) delivered over the internet to help educate and support individuals with Progressive Pulmonary Fibrosis (PFF) and their caregivers. In this study, we will enroll 80 PFF patients and 80 careparnters (total N=160 participants) who will then either receive the online SUPPORT-T program or enhanced usual care (educational handouts). At the end of the study, 15 PFF patients and caregivers who received SUPPORT-T and 5 community partners will take part in one-on-one interviews with the researchers to provide their feedback on the program; so as to improve it for a larger study. This study is being conducted by the Medical University of South Carolina in South Carolina and Mount Sinai Hospital in New York.

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

WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Alternative Post-Implant Monotherapy

Date Added
September 10th, 2025
PRO Number
Pro00141485
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

This study will have a 1:1:1 randomization post the implantation of the WATCHMAN DLX Pro Device comparing three different medications used after the WATCHMAN FLX Pro Device is placed. The goal of this study is to see how safe and effective the medications are after the device is placed. The three different arms include the following: Aspirin only for 12-month study duration, reduce dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC), either commercially available apixaban (preferred) or rivaroxaban for first 3-months, followed by aspirin, or Aspirin +clopidogrel) for first 6 months followed by aspirin only.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

Exploring Caregiving Choice in the Adult Cancer Population: A Multi-Method Study

Date Added
September 9th, 2025
PRO Number
Pro00145673
Researcher
Jennifer Huggins

List of Studies

Keywords
Cancer, Non-interventional
Summary

Using surveys researchers will assess caregiver choice, caregiver quality of life (CQOL), caregiver sleep, caregiver stress, and caregiver burden (CB). Some participants answering surveys (approximately 20), will be chosen by researchers to participate in an interview to gain a deeper understanding of the perspectives of individuals who assume caregiving responsibilities without a personal sense of choice.

Institution
MUSC
Recruitment Contact
Jennifer Huggins
854.429.2454
hugginje@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (ZION)

Date Added
September 9th, 2025
PRO Number
Pro00145511
Researcher
Charlie Strange

List of Studies


Keywords
Breathing, Inflammation, Pulmonary, Shortness of Breath
Summary

Solrikitug is an investigational drug, a drug that is still in development and testing, that can potentially benefit individuals with chronic obstructive pulmonary disease (COPD) by the pathway that causes type 2 inflammation. Solrikitug is given as an injection in the arm. Eligible participants will be randomized to receive a single dose of study medication (Solrikitug 375mg), three doses (day 1, week 4 and week 8) or placebo (inactive drug). The study is double blinded so neither the treatment team nor the participant will know what drug treatment they received. Enrollment in the study is up to 32 weeks, 4 weeks for screening and 28 weeks for treatment and follow up. Assessments conducted at the study visits include, but are not limited to, medical history and medication review, physical exams, blood tests, EKGs to look at the heart, breathing tests and questionnaires.

Institution
MUSC
Recruitment Contact
Gwen Hayden
843-792-8438
blantonm@musc.edu

The Impact of Skin Disease on Self-Reported Quality of Life and Psychosocial Health in Youth with Cutaneous Lupus Erythematosus

Date Added
September 9th, 2025
PRO Number
Pro00142882
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Lupus, Pediatrics, Skin
Summary

Cutaneous lupus is a common manifestation of childhood-onset Systemic Lupus Erythematosus (cSLE), affecting up to 85% of patients. Skin involvement can cause irritation, scarring, hair loss, changes in skin color and appearance, which may negatively impact quality of life and mental health. This study aims to assess the impact of cutaneous lupus on quality of life and mental health in diverse pediatric populations, with the goal of identifying disparities and improving individualized care. We will use validated surveys to assess disease burden on quality of life.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu



-- OR --