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

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Date Added
February 23rd, 2024
PRO Number
Pro00133321
Researcher
Kathleen Maksimowicz-McKinnon

List of Studies

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

The purpose of this study is to test whether a drug called NS-229 (the study drug) is a potential treatment for patients with Eosinophilic Granulomatosis With Polyangiitis (EGPA).

NS-229 is an investigational drug that is provided in an oral pill form. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, NS-229 will be compared with a placebo (dummy drug), having no active drug in it. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is also double-blinded study, meaning you and your study doctor will not know what you are receiving, the NS-229 or placebo.

The study is sponsored by a NS Pharma, Inc. Participation in the study will require 12 visits to the MUSC main campus over approximately 8 months. Visits are much like the your standard of care and include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), tests to assess your lung function and health (Pulmonary Function Test (PFT) and spirometry, health questionnaires. You will also be asked to complete a daily diary regarding your medication use and vasculitis symptoms.

Compensation is available for participation

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

A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Date Added
December 6th, 2023
PRO Number
Pro00130605
Researcher
Garth Swanson

List of Studies

Keywords
Complementary Medicine, Crohn's Disease, Inflammation, Inflammatory Bowel Disease
Summary

IBD affects over 1.5 million individuals in the US with an estimated direct cost of $6.1 billion. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potential modifiable risk factor. The hypothesis is that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL). A Re-Timer device will be used to administer BLT efficiently and safely to test this hypothesis. Prior to treatment subjects will be screened for subclinical inflammation using a validated questionnaire and fecal calprotectin level. They will also complete questionnaires about their dietary habits, fatigue, sleep habits, quality of life, and severity of their underlying disease. The subjects will be randomized and given BLT or the placebo non -BLT device for 4 weeks. The proposed studies will assess whether BLT has an impact on IBD patients' inflammation, intestinal permeability, and intestinal microbiota.

Institution
MUSC
Recruitment Contact
Michelle Potter
8438764261
potterm@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

Down syndrome biomarker project

Date Added
June 25th, 2020
PRO Number
Pro00090922
Researcher
Eric Hamlett

List of Studies


Keywords
Alzheimers, Blood Disorders, Brain, Children's Health, Dementia, Inflammation, Vascular
Summary

Alzheimer's disease and Epilepsy may affect over 80% of individuals that have Down syndrome by the age of 60. Biomarkers found in the blood can enhance our understanding of the earliest changes linked to disease and may enhance clinical detection and healthy aging for individuals with Down syndrome.

The purpose of this study is to discover early neurobiological processes underlying the transition from healthy aging to disease. Our research team has developed technology that allows detection of small changes in the brain that get transferred to the blood.

We are recruiting individuals that either have or do not have Down syndrome for this biomarker study. Participants should be between the ages of 6 months and 85 years old and may include mothers and siblings of a child with Down syndrome. Infants and children will require consent form a parental or legal guardian.

Each participant will provide a blood sample for research purposes. We will also gather some basic health information about senses, habits, exercise level and smoking/vaping exposures.

Institution
MUSC
Recruitment Contact
Eric Hamlett
919 357 7543
hamlette@musc.edu

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

List of Studies


Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@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

Regulation of Inflammatory T Cells and Neuroprotection by Calpain Inhibition in MS

Date Added
March 4th, 2014
PRO Number
Pro00028348
Researcher
Narendra Banik

List of Studies


Keywords
Inflammation, Multiple Sclerosis
Summary

A number of veterans suffer from multiple sclerosis (MS), a devastating and debilitating disease for which there is not cure or significant treatment. The only therapy available is immunomodulatory, but does not treat the neurodegeneration. The studies proposed in this application will develop therapeutic strategies and identify a drug that ameliorates inflammation as well as neurodegeneration in the disease. Thus, the effect of this drug will not only help veterans with MS, but will also benefit individuals with the disease in general.

Institution
MUSC
Recruitment Contact
Elizabeth Kau
789-6450
elizabeth.kau2@va.gov



-- OR --