A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis

Date Added
February 26th, 2025
PRO Number
Pro00142951
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

The purpose of this study is to measure clinical safety and efficacy of oral brepocitinib in adult participants with cutaneous sarcoidosis.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

Date Added
February 25th, 2025
PRO Number
Pro00141996
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) in people with subjects with c-Met over-expressed refractory metastatic colorectal cancer

The purpose of this study is to determine the recommended ABBV-400 dose when ABBV-400 is given alone (monotherapy) in Stage 1, and to assess if ABBV-400 monotherapy is a safe and effective treatment compared to the standard of care (SOC) LONSURF [Trifluridine and Tipiracil] plus Bevacizumab in subjects with c-Met overexpressed (level of c-Met protein in your tumor cells is increased) uncontrolled metastatic colorectal cancer in Stage 2 of the study plan.

This is a phase 3 study; ABBV-400 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, anemia, muscle aches, and joint pain. 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

A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance with Cell-free DNA versus Endomyocardial Biopsy (ACES-EMB)

Date Added
February 25th, 2025
PRO Number
Pro00141118
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Heart, Transplant
Summary

This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.

Institution
MUSC
Recruitment Contact
Madison Johnson
8437924615
johme@musc.edu

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Date Added
February 25th, 2025
PRO Number
Pro00140492
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.

Institution
MUSC
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

An open-label, single-arm study to evaluate the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents aged ≥12 to ≤17 years at the time of study inclusion with active moderate to severe hidradenitis suppurativa.

Date Added
February 13th, 2025
PRO Number
Pro00141590
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

M1095-HS-304 is a Phase 3, open-label, single-arm design that assesses the safety and tolerability of sonelokimab in adolescent patients with HS. The study population will comprise adolescent participants (aged ≥12 to ≤17 years) with moderate to severe HS.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
8438760110
yeadon@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Date Added
February 13th, 2025
PRO Number
Pro00138891
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. After a screening period of up to 30 days, approximately 1000 eligible participants (Part Ia) will be randomized in a 3:1:1 ratio to ritlecitinib 100 mg QD (600 participants), ritlecitinib 50mg QD (200 participants), and placebo (200 participants) in the 52-week placebo-controlled treatment period. At Week 52, based how patients respond to the study drug will enter the 52 week extension period.

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

A Phase IB and Randomized Phase II trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Date Added
February 12th, 2025
PRO Number
Pro00142481
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients who have been diagnosed with grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer. The investigational drug used in this study is ipatasertib. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The marketed drug used in this study is megestrol acetate (MA). Marketed means the drug has been approved by the FDA for sale and use in the United States. The primary purpose of this study is to compare the progression free survival of the combination of ipatasertib with MA to MA alone among women with metastatic grade 1-2 recurrent or metastatic endometrioid endometrial cancer. Patients will be randomized to either of the two treatments. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants orally. Participants can expect to be on this study until disease progression or adverse events prohibit further therapy.

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

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 12th, 2025
PRO Number
Pro00142401
Researcher
Lauren Sullivan

List of Studies

Keywords
Nontuberculous mycobacteria (NTM)
Summary

This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Date Added
February 12th, 2025
PRO Number
Pro00137540
Researcher
Anand Achanti

List of Studies


Keywords
Kidney
Summary

IgAN is a progressive condition that causes chronic kidney disease. Over time, some patients develop end-stage kidney disease (ESKD) requiring dialysis or kidney transplant.

The purpose of this study is to see if an investigational medication is safe and effective in the treatment of IgA nephropathy.

If you are eligible for the study and decide to participate, you will come to MUSC for study visits for about 3 years. These visits will involve blood and urine samples, questions about your health, EKGs, and physical exams. Participants will be randomized in a 1:1 ratio to receive either a weight-based IV infusion of ravulizumab or placebo for 106 weeks. Depending on your response to initial treatment, there is a possibility of additional treatment. An exploratory, open-label cohort of approximately 20 participants with eGFR 20-29 mL/min/1.73m2 may also be enrolled to expand the evidence of ravulizumab in participants with advanced kidney impairment at high risk for ESKD progression.

There is no guarantee that being in this study will help you. There is no cost to participate and compensation is available for the study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu



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