A LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH ATOPIC DERMATITIS PREVIOUSLY TREATED WITH APG777

Date Added
March 4th, 2026
PRO Number
Pro00149283
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study will evaluate the long-term safety and effectiveness of APG777 in patients with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a previous APG777 study. The study is multicenter and double-blind, and participants will continue with the same dose and injection schedule as in their prior study. The study includes three periods: a screening visit, an extended treatment period of about 92 weeks, and a post-treatment follow-up of up to 52 weeks. Patients who met certain improvement criteria in the previous study will continue their maintenance regimen, while others will enter an open-label Escape Arm with a different dosing schedule. The study aims to determine whether long-term use of APG777 is safe and effective for patients who may benefit from continued treatment.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@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

A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis

Date Added
March 5th, 2026
PRO Number
Pro00148216
Researcher
Alexander Coltoff

List of Studies

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

This study is for participants that have been diagnosed with Intermediate or High-risk Primary or Secondary Myelofibrosis. This study is testing an investigational drug called Nuvisertib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the efficacy and safety of Nuvisertib. Nuvisertib is an oral PIM1 selective inhibitor. A PIM1 selective inhibitor is a drug that specifically targets and blocks the activity of the PIM-1 kinase, an enzyme implicated in cancer cell growth. This drug is given to participants by mouth. Participants in this study can expect to be in the treatment phase of this study for 19 months and the long term follow up phase for 3 years.

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

A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT) (BXU558476)

Date Added
March 10th, 2026
PRO Number
Pro00148140
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

The purpose of this research study is to confirm the safety of the study drug (Prismocitrate 18) and the study device for patients with acute kidney injury receiving a type of dialysis treatment known as Continuous Renal replacement Therapy (CRRT). When a patient receives CRRT, a blood thinner (also known as an "anticoagulant") is frequently given. In the United States (U.S.), an anticoagulant called, Heparin, is commonly used for CRRT. Some patients have a high risk of bleeding and cannot be given heparin, because it can cause harm to them. For these patients, an anticoagulant, called citrate, can be used. The study drug being tested contains citrate. The study drug works as an anticoagulant and may also help cleanse your blood during the CRRT treatment.

Institution
MUSC
Recruitment Contact
Kayla Adler
(843) 792-0965
recruitment@musc.edu

A Phase 2, multinational, multicenter, randomized, doubleblind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe ulcerative colitis

Date Added
March 10th, 2026
PRO Number
Pro00149612
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 ulcerative colitis (UC). 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 UC. 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

A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients with Peripheral T-Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)

Date Added
March 10th, 2026
PRO Number
Pro00149742
Researcher
Ashwath Gurumurthi

List of Studies

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

This phase III trial compares the effectiveness of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Participants will be separated into two groups, or randomized (like flipping a coin). The first group of participants will receive high dose chemotherapy followed by an autologous stem cell transplant. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. The second group will be observed by the study doctor and study team with check-ins every six months for 12 years after joining the trial. The group of participants who receive a stem cell transplant will also be checked by their doctor and study team for every 6 months for 12 years after joining the study. The main risks of the study treatment include reduced blood cell counts, nausea and vomiting, and damage to other organs (due to high dose chemotherapy).

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

A Multicenter, Open-label, Long-term Extension Study for Oral Levosimendan (TNX-103)

Date Added
March 10th, 2026
PRO Number
Pro00149815
Researcher
Daniel Silverman

List of Studies

Keywords
Heart
Summary

This study will continue using the study drug levosiminden to determine if it can help people with the heart failure with preserved ejection fraction with pulmonary hypertension (HFpEF-PH). Levosimenden is an investigational drug. Investigational means that this drug is not yet approved for use in any settings outside of clinical research studies like this one. This drug is thought to assist in helping with decreasing your heart failure symptoms and increase your quality of life.

Participation in this study will last up to 60 month and will consist of about 13 clinic visits. Some tests required include physical exams, and dispensing of study medication, bloodwork.

Institution
MUSC
Recruitment Contact
Kara Loutzenhiser
843-792-1238
loutzenh@musc.edu

Horizon 360 protocol for the Treatment of Paroxysmal Atrial Fibrillation with the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Date Added
March 10th, 2026
PRO Number
Pro00149215
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the Horizon 360 System which is investigational meaning it has not yet been approved for use by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 1 year and include up to 8 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-6846
szymankr@musc.edu

Phase 4, Randomized, Double-Blind, Multicenter, Placebo Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 years old) with Attention-Deficit/Hyperactivity Disorder (ADHD)

Date Added
March 11th, 2026
PRO Number
Pro00146607
Researcher
Stephen Stripling

List of Studies

Keywords
ADD/ADHD, Children's Health
Summary

This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel group, efficacy, and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with a DSM-IV-TR diagnosis of ADHD. Approximately 286 subjects will be randomized to either SPN-812 or matching placebo in a 1:1 ratio (143 subjects per arm). Following up to 4 weeks of screening, subjects will be treated with study medication (SM) for 6 weeks, then will either be enrolled in a separate OLE study or followed for an additional 1 week for safety. The total duration of the study is up to 10 weeks.

Institution
MUSC
Recruitment Contact
Sydney Horton
843.473.6616
syh206@musc.edu

A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Date Added
March 11th, 2026
PRO Number
Pro00149360
Researcher
Katherine Antel

List of Studies

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

This study is for patients that have been newly diagnosed with GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL). This study is testing an investigational drug called zilovertamab vedotin. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In the study, participants will be randomized to two different groups (like flipping a coin). The first group will receive zilovertamab vedotin plus R-CHP [rituximab, cyclophosphamide, doxorubicin, and prednisone]. The second group will receive the standard care regimen: polatuzumab vedotin plus R-CHP. The drugs will be given through an IV, and prednisone may be given to participants by mouth. The primary purpose of the study is to learn if zilovertamab vedotin plus R-CHP is safe and effective for treating DLBCL. Participants in this study can expect to be in this study for up to 5.5 years. The first six months will be participation in treatment, and the following five years will be follow-up.

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



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