A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines

Date Added
February 10th, 2026
PRO Number
Pro00146309
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Autoimmune disease, Skin
Summary

This is a randomized, double-blind, multicenter Phase IIIb study comparing remibrutinib tablets with dupilumab injections in adults with chronic spontaneous urticaria (CSU) that is not well controlled by second-generation H1-antihistamines. Participants will receive either remibrutinib or dupilumab for 12 weeks, alongside their usual antihistamine. The goal is to see which treatment works faster and better at reducing symptoms like hives and itching. If remibrutinib is not yet available commercially after the study, participants may continue taking it in an optional extension phase.

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

Phase 1b Dose Expansion Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis

Date Added
February 11th, 2026
PRO Number
Pro00144745
Researcher
Kimberly Green

List of Studies

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

The purpose of this study is to test the safety of NXC-201 at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis.

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells (a type of white blood cell that is part of the immune system) in the bone marrow. Misfolded proteins produced by these cells can build up in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage.

NXC-201 is made using a person's own T Cells (immune system cells that protect the body from infections, cancer, and other possible harms). The T cells are collected then genetically modified (changes are made to the DNA or genes) outside of the body in a laboratory. A virus is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells. The virus then becomes inactive. The changes are designed to help the NXC-201 cells find and destroy plasma cells that have a protein on their surface called B-cell maturation antigen (BCMA). T-cell therapies like NXC-201 are called CAR T-cell therapies. After being reinjected, the CAR-T cells multiply and spread throughout the body.

NXC-201 is an investigational "treatment", which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of AL Amyloidosis or any other disease.

Calling the study drug a "treatment" in this consent form does not indicate that it will be effective in treating your AL Amyloidosis.

Before receiving NXC-201, participants will receive lymphodepleting chemotherapy (or lymphodepletion) with cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. The lymphodepletion will help prepare the body for receiving NXC-201. Cyclophosphamide and fludarabine are FDA-approved for use as lymphodepleting chemotherapy.

This study is sponsored by Nexcella, Inc., which is responsible for funding and organizing the study.

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

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo

Date Added
February 11th, 2026
PRO Number
Pro00146857
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This phase 2, multicenter, randomized, placebo-controlled, double-blind, dose-ranging trial evaluates the efficacy and safety of zasocitinib in participants with nonsegmental vitiligo. The maximum trial duration for an individual participant is approximately 61 weeks (427 days), including a screening period of up to 35 days, a treatment period of up to 52 weeks, and a 4-week safety follow-up period. Participants will be randomly assigned to a blinded treatment with zasocitinib 15 mg QD, 30 mg QD, 75 mg QD, placebo/zasocitinib 30 mg, or placebo/zasocitinib 75 mg QD, via an IRT system.

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

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF VIM0423 IN INDIVIDUALS WITH ISOLATED DYSTONIA

Date Added
February 18th, 2026
PRO Number
Pro00149062
Researcher
Christine Cooper

List of Studies


Keywords
Movement Disorders
Summary

Dystonia is a movement disorder that causes muscles to contract and/or spasm. This may be painful and can affect the person's ability to complete daily tasks. Dystonia may affect one or multiple parts of the body. Botulinum toxins (BoNT) are the only approved drug in the United States to treat dystonia, and this is only for dystonia of the neck or the eye. There are currently no approved oral treatments for dystonia. Most current treatments only provide relief of symptoms.
The purpose of this study is to learn about the effects of the research drug (VIM0423), to find the best dose for treating dystonia, and to see how safe VIM0423 is for patients with dystonia.
This research study is studying VIM0423 as a possible treatment for dystonia. It is being developed to be a combination dose of: VMA-1001 given with VMA-1002.
• VMA-1001 and VMA-1002 will be taken in separate oral doses at the same time.
• VMA-1001 is an extended release (ER) modified version of trihexyphenidyl (THP).
• VMA-1002 is a formulation of bethanechol (BTC).
THP and BTC are medicines approved by the U.S. Food and Drug Administration (FDA); however, the Sponsor is investigating a different formulation of THP referred to as VMA-1001 and a different formulation of BTC referred to as VMA-1002. The purpose is to attempt to minimize some side effects of THP and is therefore considered an investigational drug in this study. An investigational use is one that is not approved by the FDA.
You may be in this study for up to 32 weeks from the time you consent until the last study visit.
You will be seen at the study site 6 times (Screening, Day 1, Day 30, Day 60, Day 95, and Day 125) and will complete 4 telephone calls (Day 6, Day 13, Day 20 and Day 105). You may be asked to come for extra visits at any time during the study if the study doctor decides that extra tests are needed for your safety.
Side effects associated with the study drug are dry mouth, dry eyes, blurred vision, dizziness, mild nausea and feeling nervous.
You do not need to take part in this study to receive treatment for your isolated dystonia. The study doctor will explain other options that are available to you. Your other choices may include treatment with other medicines for isolated dystonia, another investigational treatment, treatment that makes you feel more comfortable but will not have an effect on your isolated dystonia, or no treatment.

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

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Date Added
February 18th, 2026
PRO Number
Pro00139005
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Study B7981028 is a Phase 3 long-term, double-blind extension study aimed at evaluating the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA). This study includes individuals who have completed previous ritlecitinib studies, B7981031 or B7981027, and are eligible to enroll in the B7981028 study. The research seeks to gather more comprehensive data on the treatment's effects over an extended period.

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

A Phase 1, open-label, dose-escalation and dose-expansion study evaluating AO-252, a protein-protein interaction inhibitor of TACC3, in patients with advanced solid tumors with or without brain metastases

Date Added
February 24th, 2026
PRO Number
Pro00148001
Researcher
Brian Orr

List of Studies

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

This study is for patients that have been diagnosed with metastatic or locally advanced unresectable solid tumors with tumor protein 53 (TP53) mutation/loss with or without brain metastasis. This study is testing an investigational drug called AO-252. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the maximum tolerated dose (MTD), the recommended phase II does (RP2D), and the safety profile of AO-252. The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months, followed by a 12-month follow-up period.

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

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)

Date Added
February 26th, 2026
PRO Number
Pro00148568
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

A 144-week clinical research study to look at how well an investigational obesity medicine works, along with a reduced-calorie diet and increased physical activity in participants with obesity.
The medicines are injected subcutaneously (under the skin) once a week.
This study also includes a placebo.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

At-home transcutaneous auricular neuromodulation (tAN) for women with postpartum depression: an open label trial

Date Added
March 3rd, 2026
PRO Number
Pro00149664
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Anxiety, Depression, Women's Health
Summary

This is an open-label pilot study firstly assessing safety and feasibility of a form of ear stimulation called transcutaneous auricular neuromodulation, or tAN, in women with postpartum depression (PPD). Secondly, we will be assessing the impact of at-home tAN on mood, empathy, and physiological markers of sympathetic activity in women with PPD. Participants will learn how to self-administer ear stimulation treatments in the lab before starting the at-home study. Over the course of one week, participants will self-administer ear stimulation treatments three times a day. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study, as well as undergo heart rate variability (HRV) assessments and provide salivary samples. There will also be a smaller number of questionnaires completed electronically at the midpoint of the study. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and feelings towards their newborn.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris

Date Added
March 3rd, 2026
PRO Number
Pro00149812
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

The purpose of this clinical research study is to learn more about the use of an investigational medicine, called brepocitinib, for the treatment of Lichen Planopilaris (LPP). The study will also look at how safe and effective brepocitinib is and will monitor the long-term safety of brepocitinib when taken for a period up to 52 weeks.

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

A Phase 2, multinational, multicenter, randomized,double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's disease.

Date Added
March 5th, 2026
PRO Number
Pro00149007
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System
Summary

The study aims to evaluate if an experimental drug called SAR441566 can improve signs and symptoms of moderate to severe Crohn's disease (CD). SAR441566 is a new drug that inhibits Tumor necrosis factor receptor 1 (TNFR1) signaling. This study will also help the Sponsor to understand which dose of SAR441566 is most effective and safe in participants with moderate to severe CD. To do this, 3 different doses of SAR441566 will be tested along with a placebo. The study will last about 1 year, will include about 260 adult participants across over 26 countries.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437921221
recruitment@musc.edu



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