A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa

Date Added
September 3rd, 2024
PRO Number
Pro00137485
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a pivotal Phase 3, global, randomized, double-blinded, placebo-controlled, multicenter study to evaluate efficacy and safety of lutikizumab in subjects 16 years of age and older with moderate to severe HS. The study comprises a 35-day Screening Period, a 16-week placebo-controlled double-blinded period (Period 1), a 36-week double-blinded extension (Period 2), and a 10-week (70 days) Follow-Up Period after last study drug dosing or an option to enter a separate long term extension study.

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

Mobile Health Reaction Time and Behavior Study

Date Added
September 3rd, 2024
PRO Number
Pro00138757
Researcher
Austin Hahn

List of Studies

Keywords
Alcohol
Summary

This study tests a mobile app that aims to reduce alcohol use and risky sexual behavior.

Interested individuals will complete an online screener to see if they are eligible. Eligible participants will be consented into the study, and study participation involves six mobile sessions over the course of about 45 days.

The first and the last session will be completed via video conference with a member of the research staff. The second through fifth sessions are completed independently on the mobile app. Sessions involve survey questionnaires, clinical interviews, and computerized tasks. Participants will be compensated for completed study sessions.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-779-2552
boatrigh@musc.edu

Group Parenting Program for Managing Disruptive Behavior in Young Children

Date Added
September 8th, 2024
PRO Number
Pro00138994
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
ADD/ADHD, Autism, Pediatrics
Summary

The purpose of this research is to assess a group-based telehealth parenting program for child ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based telehealth PCIT sessions, and an online post intervention assessment. Families will be compensated for their time.

Institution
MUSC
Recruitment Contact
Alexandra Marsden
843-714-1352
autismresearch@musc.edu

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

Date Added
September 10th, 2024
PRO Number
Pro00136698
Researcher
Thai Ho

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) for locally advanced or metastatic solid tumors with oncogene amplifications to determine if any of these study treatments improve overall survival as compared to standard treatments.

The goal is to determine the optimal dose level, safety, and tolerability for the study drug BBI-355. This is the first study to test the study medicine BBI-355 in humans; BBI-355 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 orally, blood and urine samples, diary entries, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, muscle weakness, dizziness, and headaches. 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 phase 1b study of sovilnesib (an oral KIF18A inhibitor) in subjects with advanced high grade serious ovarian cancer

Date Added
September 10th, 2024
PRO Number
Pro00136860
Researcher
Brian Orr

List of Studies

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

This study is for subjects that have been diagnosed with advanced high grade serious ovarian cancer. The investigational drug used in this study is Sovilnesib. The main purpose of this study is to is to establish the recommended phase 2 dose, which will be considered the optimal dose, of Sovilnesib. Additionally, this study will examine the safety, tolerability and preliminary efficacy of Sovlinesib. The total time you will be on the study treatment will depend on if you have any unwanted side effects and how your cancer is responding to treatment.

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

A Phase 3, Multicenter, Randomized, Double-blind, Single-dose Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects with Glenohumeral Osteoarthritis.

Date Added
September 10th, 2024
PRO Number
Pro00134950
Researcher
Josef Eichinger

List of Studies


Keywords
Arthritis, Bone, Drug Studies, Pain
Summary

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution) and the current treatment of TCA-IR (Triamcinolone Acetonide, immediate release). The study drug is administered through an ultrasound-guided injection to the affected shoulder. Forty percent of subjects will receive Zilretta, forty percent will receive TCA-IR and twenty percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-85 years of age, BMI under 40, who have been diagnosed with Osteoarthritis of the shoulder by x-ray and has had pain for over 15 days out of the past month. The study has 10 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.

Institution
MUSC
Recruitment Contact
Robert Reis
8437925025
reisb@musc.edu

A Phase 1/2, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Date Added
September 12th, 2024
PRO Number
Pro00136971
Researcher
Praneeth Baratam

List of Studies

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

This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. 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

A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia

Date Added
September 18th, 2024
PRO Number
Pro00138636
Researcher
Thomas Uhde

List of Studies


Keywords
Depression, Mental Health
Summary

This study will assess an adjunctive treatment for major depressive disorder (MDD) called Aticaprant. Adults with MDD that are currently on an antidepressant but continue to experience prominent anhedonia may qualify.

Institution
MUSC
Recruitment Contact
Matthew Woodson
8437925428
woodsonm@musc.edu

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Date Added
September 23rd, 2024
PRO Number
Pro00138505
Researcher
John Kaczmar

List of Studies


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

This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.

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

Strategy for Improving Stroke Treatment Response

Date Added
September 26th, 2024
PRO Number
Pro00136289
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843 792 8606
lemattyc@musc.edu



-- OR --