A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of CC-220 In Subjects With Active Systemic Lupus Erythematosus Save

Date Added
November 14th, 2017
PRO Number
Pro00069388
Researcher
Holly Mitchell

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Keywords
Lupus
Summary

The purpose of this study is to see if a new drug called CC-220 can be safe and effective to treat patients with Systemic Lupus Erythematosus. CC-220 is an oral medication. The study will last for about one year and will involve 16 study visits. There are two parts to the trial: In the first, patients will be assigned to get either CC-220 at 0.45mg, 0.3mg, 0.15 mg, or placebo (no active study drug). In the second part, all patients who got placebo during the first part will be re-assigned to get CC-220 at either 0.45mg or 0.3mg. The study will be blinded, which means you will not know which medication you are getting during either of the two parts. You will see a Rheumatologist, and give a blood and urine sample at each visit. The data obtained from this study will provide additional information to further assess the benefit and risk profile of CC-220 for the treatment of lupus.

Institution
MUSC
Recruitment Contact
Daniel Melcher
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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

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
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

Development of CSD-Based Therapies: Novel Indications and Improved Versions of CSD Save

Date Added
September 26th, 2017
PRO Number
Pro00069613
Researcher
Stanley Hoffman

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Keywords
Heart, Lung, Lupus, Scleroderma
Summary

We have already observed that the blood cells known as monocytes from patients with the fibrotic disease scleroderma behave differently from monocytes from healthy controls. Here we will test whether patients with other fibrotic diseases also have altered monocyte function. Specifically, we will get blood from congestive heart failure and lupus patients and compare their monocytes to scleroderma patient and healthy subject monocytes. Our recent results in a mouse model for congestive heart failure suggest that we will find altered monocyte behavior in human congestive heart failure patients.

Institution
MUSC
Recruitment Contact
Elena Tourkina
843-792-7319
tourkine@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

Pathway Exploration and Analysis in Renal Lupus Save

Date Added
July 18th, 2017
PRO Number
Pro00067258
Researcher
Diane Kamen

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Keywords
Autoimmune disease, Kidney, Lupus
Summary

The purpose of the study is to characterize the inflammatory response in lupus nephritis kidneys in order to identify the cellular and molecular pathways of injury. It will involve patients who are already scheduled to have a kidney biopsy to clarify the diagnosis of lupus nephritis and/or to guide therapy. During the biopsy, doctors will take an extra "core" of kidney tissue for research purposes in addition to the one used for clinical reasons. If you enroll in the trial, you will have 7 visits, including your kidney biopsy. The first two visits occur within 2 weeks, then follow up visits after 3, 6, 12, 18 and 24 months.

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

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (Protocol ALE09) Save

Date Added
July 18th, 2017
PRO Number
Pro00063016
Researcher
Diane Kamen

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Keywords
Autoimmune disease, Drug Studies, Inflammation, Lupus
Summary

This double-blinded placebo-controlled research study is being done to test the effectiveness, safety, and tolerability of the experimental drug JBT-101 in patients with systemic lupus erythematosus (SLE). We will see if JBT-101 taken by mouth stops inflammation and how well JBT-101 is tolerated. The study will evaluate whether JBT-101 will decrease the pain associated with active arthritis or tendonitis in SLE subjects. JBT-101 is manufactured entirely from chemicals and its structure is similar to the end product of a chemical in marijuana. This drug was designed to have the known anti-inflammatory properties of marijuana without the effects on brain function and mood.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

Study of Anti-Malarials in Incomplete Lupus Erythematosus Save

Date Added
July 18th, 2017
PRO Number
Pro00060015
Researcher
Diane Kamen

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Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The primary objective of the trial is to assess the ability of hydroxychloroquine to prevent the development of SLE in persons at risk for the disease. Subjects will be assigned to one of two groups: one with receive oral hydroxychloroquine, and one will receive oral placebo. The study lasts for about two years, with visits being once every 3 months, for a total of 12 visits. Two of those visits will be with an ophthalmologist to monitor eye health. At each visit, the study team will monitor your symptoms and health.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. Save

Date Added
January 24th, 2017
PRO Number
Pro00059452
Researcher
Dirk Elston

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Keywords
Drug Studies, Lupus
Summary

Part A of the study is for people who have Systemic Lupus Erythematosus (SLE) and have active skin disease. This study will look at how well different doses of the study drug BIIB059 works in reducing active skin disease and other lupus manifestations in patients with SLE during 24 weeks of treatment. This study will also look at how well patients tolerate the doses of study drug being tested in this study and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.

Part B of the study is for people who have active cutaneous lupus erythematosus (CLE) with or without signs of systemic LE. This study will look at how well the study drug BIIB059 works in reducing skin disease in patients with CLE after 4 to 12 weeks of treatment. This study will also look at how well patients tolerate the study drug and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus Save

Date Added
December 20th, 2016
PRO Number
Pro00061632
Researcher
Gary Gilkeson

Silhouette
Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to evaluate the safety of mesenchymal stem cells (MSCs) obtained from an umbilical cord for the treatment of adults with systemic lupus erythematosus (SLE). The primary goal is to determine if a single MSC infusion is safe and well-tolerated for patients with mild to moderately active SLE.

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

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