A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

Date Added
September 22nd, 2025
PRO Number
Pro00147095
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The Propel study is for adults up to 75 years of age with Generalized Myasthenia Gravis (gMG) and looks at the efficacy of IMVT-1402 which is a once weekly subcutaneous investigational drug. The study contains a screening period, two blinded treatment periods, and a follow-up period. Treatment period one is 12 weeks, and participants will be randomized to 600 mg IMVT-1402, 300 mg IMVT-1402, or placebo during this time. Treatment period two is 14 weeks, and all participants will receive either 600 mg IMVT-1402 or 300 mg IMVT-1402 during this time. Total participation in the study will be about 35 weeks. Various medications used as standard of care for gMG will be allowed in this study, so participation does not necessarily require stopping current gMG treatment.

Institution
MUSC
Recruitment Contact
Emma McLeod
843-792-8008
mcleodem@musc.edu

A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)

Date Added
September 16th, 2025
PRO Number
Pro00146859
Researcher
Brian Lally

List of Studies

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

The purpose of this study is to compare the usual treatment alone to the usual treatment plus dose escalated radiation. This study seeks to find if this approach is better or worse than standard of care for locally advanced pancreatic cancer. Treatment and follow up for this study may be up to 8 years. The procedures include CT or MRI scans, chemotherapy, and radiation therapy. Risks include stomach pain, diarrhea, nausea, vomiting, tiredness, muscle aches, and weight loss. You 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

BabySTrong (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding

Date Added
September 16th, 2025
PRO Number
Pro00146417
Researcher
Dorothea Jenkins

List of Studies


Keywords
Infant, Nerve
Summary

Preterm and term infants with brain injury frequently have difficulty learning to feed by mouth. Transcutaneous vagus nerve stimulation (taVNS) may be paired with the motor activity of feeding to boost brain circuits involved with feeding. This study will test a taVNS-paired bottle system in a blinded, randomized, controlled trial in infants who have reached term age and failed to learn to feed. Our preliminary data indicates that most infants improve their volume of oral feeds with the BabySTrong system, and 50-70% achieve full oral feeds and avoid placement of a gastrostomy tube (G-tube) or home nasogastric tube. The BabySTrong feeding system may improve oral feeding volumes and help infants and their families avoid a long hospital stay while trying to learn to feed.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-792-2112
boatrigh@musc.edu

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



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