A RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF PRIVOSEGTOR (OCS-05) IN PATIENTS WITH OPTIC NEURITIS (ON)

Date Added
June 18th, 2026
PRO Number
Pro00150245
Researcher
Eric Berman

List of Studies


Keywords
Brain, Inflammation, Vision/ Eye
Summary

Optic neuritis (ON) is a rare inflammatory disorder of the optic nerve that results in vision loss. It is characterized by rapid and variable vision loss, pain in, around and behind the eye, and changes in color vision. Subjects in this study will be followed for 12 months total and randomized in a 2:1 ratio to receive either an IV infusion medication or a placebo infusion. Low Contrast Visual Acuity will be tracked at 3 months. After 3 months, participants will continue the study
through Month 12 in the safety follow-up part of the study intended to provide longer
term safety information.

Institution
MUSC
Recruitment Contact
Martha Long
843-792-6591
longmart@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (ZION)

Date Added
September 9th, 2025
PRO Number
Pro00145511
Researcher
Charlie Strange

List of Studies


Keywords
Breathing, Inflammation, Pulmonary, Shortness of Breath
Summary

Solrikitug is an investigational drug, a drug that is still in development and testing, that can potentially benefit individuals with chronic obstructive pulmonary disease (COPD) by the pathway that causes type 2 inflammation. Solrikitug is given as an injection in the arm. Eligible participants will be randomized to receive a single dose of study medication (Solrikitug 375mg), three doses (day 1, week 4 and week 8) or placebo (inactive drug). The study is double blinded so neither the treatment team nor the participant will know what drug treatment they received. Enrollment in the study is up to 32 weeks, 4 weeks for screening and 28 weeks for treatment and follow up. Assessments conducted at the study visits include, but are not limited to, medical history and medication review, physical exams, blood tests, EKGs to look at the heart, breathing tests and questionnaires.

Institution
MUSC
Recruitment Contact
Gwen Hayden
843-792-8438
blantonm@musc.edu

Identification of proinflammatory biomarkers in episodic recurrent vertigo to differentiate Meniere's disease from Vestibular Migraine

Date Added
November 7th, 2024
PRO Number
Pro00140623
Researcher
Habib Rizk

List of Studies


Keywords
Ears, Genetics, Hearing, Inflammation
Summary

We are interested in seeing which biomarkers are involved in the pathophysiological pathways of vestibular migraine and Meniere's disease. To this end, we will have eligible patients undergo peripheral blood draws to establish a biobank. The blood samples collected will undergo in vitro testing to determine the cytokine profiles of the immune cells and will also undergo genetic testing. Data and samples collected will be used for future studies as well.

Institution
MUSC
Recruitment Contact
Habib Rizk
843 876-0112
rizkh@musc.edu

Impact of Nd: YAG laser photobiostimulation on healing of gingiva following tooth extraction and alveolar ridge preservation

Date Added
October 15th, 2024
PRO Number
Pro00139090
Researcher
Pinar Emecen-Huja

List of Studies


Keywords
Inflammation, Pain, Periodontal Disease
Summary

This study aims to determine if photo biostimulation with Nd-YAG laser improves wound healing following tooth extraction and alveolar ridge preservation. The impact of laser treatment on wound healing will be evaluated by levels of salivary inflammatory biomarkers, gingival wound size, and surveying for pain reduction and patient satisfaction. The intervention group will receive standard-of-care extraction and alveolar ridge preservation with adjunct Nd-YAG laser photobiostimulation on days 1, 3, and 7, while the control group will receive the standard-of-care extraction and alveolar ridge preservation only.

Institution
MUSC
Recruitment Contact
Pinar Emecen-Huja
8439725688
emecenh@musc.edu

A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Subjects With Antineutrophil Cytoplasmic Antibody (ANCA)-associated Vasculitis

Date Added
April 10th, 2024
PRO Number
Pro00136129
Researcher
Kathleen Maksimowicz-McKinnon

List of Studies

Keywords
Autoimmune disease, Drug Studies, Inflammation, Rare Diseases, Stage IV, Vasculitis
Summary

The purpose of this study is to learn more about long-term safety (good or bad effects) of avacopan and its efficacy (how well it is working) in treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.

Avacopan is currently approved as an adjunctive (another treatment used along with primary treatment) treatment in adult people with severe active ANCA-associated vasculitis in the US and is also approved in the EU, Canada, Japan, and other countries.

In this study, avacopan will be compared with a placebo (a drug that looks likes the study medication but does not contain any medication). This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) into a treatment group. You will have an equal chance of being placed in either of the 3 following groups: treatment with avacopan for 5 years in group A, or treatment with avacopan for 1 year followed by placebo for 4 years in group B, or treatment with placebo for 5 years in group C. The study is also a double-blinded study, meaning you and your study doctor will not know what you are receiving, the avacopan or placebo.

The study is sponsored by Amgen, Inc. Participation in the study will require 27 visits to the MUSC main campus over approximately 63 months, and visits will include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), and health questionnaires. You will also be provided with a paper diary to record any missed doses/overdoses of the study drug.

Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Kathleen Maksimowicz-McKinnon
843-792-0066
maksimow@musc.edu

Pediatrics Biorepository for Gastroenterology Clinical Research

Date Added
March 7th, 2023
PRO Number
Pro00126239
Researcher
Benjamin Kuhn

List of Studies

Keywords
Digestive System, Esophagus, Inflammation
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Gastroenterology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop novel diagnostic approaches and identify therapeutic targets.

Institution
MUSC
Recruitment Contact
Benjamin Kuhn
(843) 876-0444
kuhnbe@musc.edu

A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis

Date Added
March 7th, 2023
PRO Number
Pro00126501
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Drug Studies, Immune System, Inflammation, Kidney, Lupus
Summary

The purpose of this study is to determine if the investigational (not FDA approved) drug VIB4920 can be an effective treatment for patients with active Lupus Nephritis (LN).

This study will compare treatment with MMF (mycophenolate mofetil), Prednisone, plus the study medication VIB4920 to treatment with MMF and Prednisone alone.

Participants will have up to 15 scheduled visits that will involve routine monitoring of disease activity, up to two kidney biopsies, and blood and urine specimen collections. Participation in this study will last approximately 1 year and 2 months. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Stephanie Dezzutti
843-792-8997
brays@musc.edu

Attenuation of Inflammatory Response in Progressive Neurodegeneration in Parkinson's disease

Date Added
May 29th, 2014
PRO Number
Pro00033613
Researcher
Narendra Banik

List of Studies


Keywords
Inflammation, Movement Disorders, Parkinsons
Summary

This is an exploratory study and the information obtained may lead to new findings regarding the inflammatory and neurodegenerative mechanisms in the progression of PD and help to develop new drugs to halt the disease progression. The study simply involves a one time blood draw.

Institution
MUSC
Recruitment Contact
Christina Vaughan
792-7262
jenkisho@musc.edu



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