A randomized, double-blind, placebo-controlled, multicenter phase 2 study of AK117/placebo in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes

Date Added
May 22nd, 2024
PRO Number
Pro00136718
Researcher
Praneeth Baratam

List of Studies

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

This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

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

Development of a mHealth Post-Stroke Home Exercise Program with Remote Monitoring and Intervention

Date Added
May 21st, 2024
PRO Number
Pro00137156
Researcher
Na Jin Seo

List of Studies


Keywords
Exercise, Movement Disorders, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Adherence to home exercise is important to achieve upper limb recovery after stroke. However, adherence is typically low. Therefore, a new home exercise program with an Apple Watch and iPhone app was created to improve adherence to upper limb exercises for stroke survivors at home. Participants will come to our lab to experience the new home exercise program. Participants who opt for home use will bring the device home to try the new home exercise program at home. The purpose of this study is for researchers to examine usability and feasibility of participants using the new home exercise program.

Institution
MUSC
Recruitment Contact
Ja'Quann Gallant
843-792-0162
gallantj@musc.edu

Clinical Evaluation of The APEX 3D™ Total Ankle Replacement System

Date Added
May 16th, 2024
PRO Number
Pro00136072
Researcher
Christopher Gross

List of Studies


Keywords
Joint, Pain
Summary

The APEX 3D™ Total Ankle Replacement System is intended to reduce pain and restore motion to a failing ankle joint due to rheumatoid, post-traumatic, or degenerative arthritis. In 2020, the APEX 3D™ Total Ankle Replacement System received 510(K) clearance from the FDA, demonstrating that the device is marketed as safe and effective. The primary objective of this research study is to determine implant survivorship. Enrollment is expected to take approximately one to two years. All subjects will be followed for ten years post-operatively. Study follow-up visits will occur at 6-weeks, 6-months, and annually for ten years after surgery. During the pre-operative visit and each follow-up visit, subjects will be asked to complete a series of questionnaires that assess their levels of pain, function, mobility, and quality of life. Comparison of pre-operative scores to post-operative scores can be used to assess the improvement in patient function, thus supporting the benefit and clinical performance of the intervention. As with any clinical research study, there is a risk of unintended personal health information disclosure.

Institution
MUSC
Recruitment Contact
Seth Tysor
3362122921
tysor@musc.edu

An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Date Added
May 14th, 2024
PRO Number
Pro00136776
Researcher
Daniel Judge

List of Studies


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

This study is an open label extension study for those who participated in the ION 682884-CS2 clinical trial for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a disease caused by change in a protein called transthyretin (TTR) which can result in a build up of this protein in parts of the body including the heart. This build up is called an amyloid deposit, and when this occurs in the heart it can lead to a condition called cardiomyopathy. This study involves the medication eplontersen, which is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration (FDA). Eplontersen is aimed at preventing production of the TTR protein to slow or reverse disease progression. Eplontersen is given as an injection under the skin in the upper arm, stomach or thigh. This study will last about 3 1/2 years and include 16 clinic visits. Study procedures include physical exams, blood work, questionnaires, hall walk tests, electrocardiograms (tracing of the heart's electrical activity), echocardiogram (ultrasound test of the heart) and taking a Vitamin A supplement.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A Phase II, Multicenter, Single-Arm Clinical Trial of Definitive Radiotherapy And CeMiPlimAb-Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

Date Added
May 14th, 2024
PRO Number
Pro00133909
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is to treat cutaneous squamous cell cancer that cannot be removed with surgery and is relatively large or has spread beyond its original location with the combination of radiation therapy and cemiplimab. Cemiplimab is FDA approved for this head and neck cancer, but the combination of cemiplimab and radiation is investigational. This treatment consist of 17 weeks of cemiplimab followed by 7 weeks of cemiplimab + radiation followed by 28 weeks of cemiplimab alone. There will be 3 clinic visits during treatment so the study doctor can check on the participant's health and see if they are having any side effects. Some of the most common risk and side effects that the study doctors know about are lack of energy or feeling tired (fatigue), loose or watery stools (diarrhea), rash, allergic reaction to study drug, and possible effects on liver, kidney, heart, and blood. Treatment will last a year with a follow-up call at the end of year 2.

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

A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of a 12-week administration of OATD-01, an oral inhibitor of chitinase-1 (CHIT1), for the treatment of active pulmonary sarcoidosis (the KITE study)

Date Added
May 7th, 2024
PRO Number
Pro00136799
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

The study will test OATD-01, an experimental medicine, for the first time in patients with pulmonary sarcoidosis (swollen tissue in the lungs). The study goal is to evaluate OATD-01 in the reduction of inflammation and assessing OATD-01 safety.

Everyone who participates in this study will receive OATD-01 or matching placebo (inactive mock tablet). Subjects will be randomly assigned to receive either OATD-01 or placebo for 12 weeks.

The study will run in several hospitals or outpatient clinics, in different countries in Europe and in the USA. In this study, there will be about 98 study subjects in total.

For all patients whether taking OATD-01 or matching placebo, there will be a screening period, a treatment period which will commence after randomization has taken place and will last for 12 weeks and then a follow up visit approximately 4 weeks post last dose of OATD-01.

The total duration of the study is 18 weeks.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 1 Open Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

Date Added
May 7th, 2024
PRO Number
Pro00136641
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to evaluate ABBV-400 in subjects with select solid tumors. This study will consist of
multiple cohorts with each cohort investigating ABBV-400 at 3 mg/kg Q3W.
The study will consist of a Screening, a Treatment, and a Follow-Up period.
All screening procedures must be performed within 28 days of first dose with the exception of tumor
tissue biopsy, which may occur during screening or any time after disease progression on the most
recent treatment. Subjects will continue treatment with ABBV-400 3 mg/kg Q3W until documented disease progression,
intolerable toxicity, or the subject meets other protocol criteria for discontinuation of treatment
(whichever occurs first). The maximum treatment duration will be 2 years.

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

Randomized controlled trial of varenicline to treat tobacco and cannabis co-use

Date Added
May 7th, 2024
PRO Number
Pro00136115
Researcher
Erin McClure

List of Studies