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

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa

Date Added
October 24th, 2024
PRO Number
Pro00137663
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a Phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of sonelokimab in adults with moderate to severe HS. Following a Screening Period of up to 28 days, each participant will enter a Placebo-controlled Period of 16 weeks (Part A) and subsequently a Crossover/Maintenance Period of 36 weeks (Part B). In Part A subjects will be randomly assigned in a 2:1 ratio to sonelokimab 120 mg or placebo. In Part B, participants who were initially randomized to placebo will cross over to sonelokimab and will receive this treatment for the remainder of the study. An End of Treatment (EOT) Visit will be performed at Week 52. After the EOT Visit, all participants who complete Week 52 will be offered the opportunity to enter an optional long-term open label extension (OLE) study under a separate protocol. For participants who do not progress to the OLE study, a Safety Follow-up Visit will be required 8 weeks after the last dose of study treatment.

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

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab by subcutaneous injection in participants aged 12 years and older with moderate to-severe atopic dermatitis (AD) who are on background topical corticosteroids and have had an inadequate response to prior biologic therapy or oral Janus Kinase (JAK) inhibitor treatment

Date Added
November 21st, 2024
PRO Number
Pro00138920
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Pediatrics, Skin
Summary

This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multiple dose level study to investigate the efficacy and safety of subcutaneous injections of amlitelimab in participants aged 12 years and older with moderate-to-severe AD who are on background topical corticosteroids or calcineurin inhibitors and have had an inadequate response to prior biologic or oral JAKi therapy. There will be up to 13 visits including up to a 4-week screening period, a 36 week treatment period, and a post-treatment safety follow up period or a long-term Safety Study for 16 weeks. Subjects will be randomized in a 1:1:1 ratio to the following study arms: amlitelimab Q4W, amlitelimab Q12W, and placebo Q4W.

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

A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Date Added
December 10th, 2024
PRO Number
Pro00138267
Researcher
John Kaczmar

List of Studies


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

This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. 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 receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. 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 Petosemtamab 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

A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System vs. Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study).

Date Added
December 10th, 2024
PRO Number
Pro00141175
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study involves a procedure called renal denervation with an investigational device called the TIVUS™ system for the treatment of resistant hypertension (high blood pressure). Investigational means it is not yet approved for commercial use by the Food and Drug Administration (FDA). Renal denervation is a procedure done by introducing a catheter (long tube) into the large blood vessel in your groin (top of leg) and guiding it to your renal arteries, which are the blood vessels that go to your kidneys. The catheter will be placed in the renal arteries and ultrasound energy will be delivered to the renal arteries.
This study is randomized, meaning you will be assigned to one of two groups, by chance, like drawing straws. Two out of three participants will be randomized to renal denervation while one out of three will be randomized to sham. Sham means you will go through all the steps of the procedure but will not receive the treatment. Those participants randomized to sham will have the option to crossover and have the procedure after the 6 month follow up.
This study will involve at least 12 visits over the course of 36 months. Study related procedures include CT scan, ultrasound test of your heart and kidneys, blood work, urine studies, physical exams, questionnaire, and keeping home blood pressure diaries.
Study related risks include risks related to the procedure including pain, bleeding, damage to the blood vessels, risks related to the study related testing such as radiation risks, blood draw risks and loss of confidentiality. There may be benefit to you as well as others in the future with high blood pressure.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
January 24th, 2025
PRO Number
Pro00137514
Researcher
Zeke Campbell

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the long term effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. You could be eligible to participate in the study if you completed the first double blind study successfully and your study doctor see's that you meet all the criteria for this study.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Date Added
February 14th, 2025
PRO Number
Pro00141956
Researcher
Brian Orr

List of Studies

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

This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). 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 optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.

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

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for low Tumor Burden Follicular Lymphoma

Date Added
March 6th, 2025
PRO Number
Pro00142136
Researcher
Brian Hess

List of Studies


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

This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.

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

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Date Added
March 28th, 2025
PRO Number
Pro00141998
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

This Phase 3, randomized, placebo-controlled, double-blind study evaluates the efficacy and safety of Upadacitinib in adults and adolescents with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy. The study includes a 35-day screening period, a 16-week placebo-controlled, double-blind treatment period (Period 1), a 20-week re-randomized extension treatment period (Period 2), a 68-week long-term extension treatment period (Period 3), and a 30-day follow-up period.

Institution
MUSC
Recruitment Contact
Neharika Talasila
843-792-6882
talasila@musc.edu

A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared with Placebo in Participants with Alcohol Use Disorder

Date Added
April 23rd, 2025
PRO Number
Pro00142519
Researcher
Sarah Book

List of Studies


Keywords
Substance Use
Summary

This is a 28-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, Mazdutide, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to Mazdutide or a matched placebo

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu



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