A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Save

Date Added
October 24th, 2018
PRO Number
Pro00077684
Researcher
Eric Zollars

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Keywords
Autoimmune disease, Lupus, Skin
Summary

The purpose of this research study is to measure how well and how safe BMS-986165 is in treating patients with Systemic Lupus Erythematosus (SLE) and to determine the optimal dose level.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash (redness of the skin), sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for Lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (such as prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for Lupus.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

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Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

Role of microbiota-TLR7/8 Interaction in systemic lupus erythematosus Save

Date Added
September 5th, 2018
PRO Number
Pro00079851
Researcher
Chenthamarakshan Vasu

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Keywords
Autoimmune disease, Immune System, Inflammation, Lupus
Summary

The goal of this study is to learn more about lupus (Systemic Lupus Erythematosus; SLE), which affect African-Americans more than other groups. The purpose of this study is to understand what role microbes living in the intestine (called microbiota) have in causing lupus. This study will include African-Americans who have SLE, individuals who have immediate family members with SLE and unrelated healthy volunteers. For study subject recruitment, CCCR/MCRC databases including the longitudinal SLE in Gullah Health (SLEIGH) study as well as the chart review will be used to screen for eligibility. The study is sponsored by the National Institutes of Health.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-8997
faitht@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis Save

Date Added
July 10th, 2018
PRO Number
Pro00079009
Researcher
Edwin Smith

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Keywords
Autoimmune disease, Drug Studies, Inflammation, Scleroderma, Skin, Stage III
Summary

SSc, which also can be called scleroderma, is a rare autoimmune disease. Autoimmune diseases such as SSc make your immune system over-active which causes chronic inflammation. This chronic inflammation leads to scar tissue, or fibrosis, of the skin and some internal organs.

The skin and involved internal organs with chronic inflammation from SSc become scarred over time, which makes them not work as well as they should. Lenabasum may help stop chronic inflammation, and stop scarring from getting worse without lowering the immune system.

This study is currently enrolling subjects who have scleroderma and are 18 years or older. Participation in the study will require you to complete 13 scheduled visits over the course of one year. After the completion of each visit, subjects will be compensated.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-4844
faitht@musc.edu

Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease Save

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

IDENTIFICATION OF ACCESSIBLE CHROMATIN MARKS IN ACTIVATED DENDRITIC CELLS FROM FEMALE AND MALE SLE PATIENTS Save

Date Added
November 16th, 2017
PRO Number
Pro00069599
Researcher
Melissa Cunningham

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Keywords
Autoimmune disease
Summary

Systemic lupus erythematosus (SLE, lupus) is an autoimmune disorder characterized by dysregulated immune responses and subsequent production of autoantibodies. In recent years, data suggests that changes in certain kinds of immune cells, dendritic cells, affect development of lupus.

Institution
MUSC
Recruitment Contact
John LeMay
843-792-5824
lemay@musc.edu

IDENTIFICATION OF PERIPHERAL BLOOD CELL SUBSETS DYSREGULATED IN LUPUS AND SCLERODERMA Save

Date Added
October 17th, 2017
PRO Number
Pro00069048
Researcher
Paula Ramos

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Keywords
Autoimmune disease, Immune System, Lupus, Scleroderma
Summary

Often considered as related diseases, systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) are severe autoimmune disorders characterized, among other, by dysregulation of immune cells in the blood. The roles of different immune cells in SLE and SSc remain unclear. It is of increasing importance to characterize specific immune cells and define their impact on autoimmune disease, which may lead to new therapies. The goal of this study is to identify blood immune cells associated with SLE and SSc.

Institution
MUSC
Recruitment Contact
John LeMay
843-792-5824
lemay@musc.edu

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (Voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus Nephritis Save

Date Added
September 26th, 2017
PRO Number
Pro00069657
Researcher
Melissa Cunningham

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Keywords
Autoimmune disease, Lupus
Summary

The primary objective of the study is to assess whether Orelvo, added to the standard of care treatment for patients with Lupus Nephritis, is able to reduce disease activity. The study will last for about 1 years and will involve 16 study visits. Patients who meet criteria will be assigned to one of two groups: One group will receive Orelvo 23.7mg taken twice a day by mouth, and the other will receive placebo. The study is blinded, with means neither the patient nor the study doctor will know what group subjects are in. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 1 year.

Institution
MUSC
Recruitment Contact
Amanda Pizzo
843-792-8613
pizzo@musc.edu

A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects with Lupus Membranous Nephropathy (LMN) Save

Date Added
August 8th, 2017
PRO Number
Pro00068913
Researcher
James C. Oates

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Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to see if filgotinib and/or GS-9876 can be safe and helpful to treat patients with Lupus Membranous Nephropathy. These are both oral medications. The study will last for about one year and will involve 18 study visits. Patients will be assigned to get either filgotinib or GS-9876 at the beginning of the study. At Week 16, they will be evaluated to see if their LMN is improving. If so, they will remain on whichever drug they received. If not, they will switch to the other drug. At Week 32, patients will once again be evaluated. Based on those results, patients may remain on the same drug, or switch to the other group. This process will be blinded so that even though you will always be getting active drug, you will not know which one.

Institution
MUSC
Recruitment Contact
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

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