A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis

Date Added
September 15th, 2022
PRO Number
Pro00123287
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy. The duration of patient participation is up to 56 weeks, including a Screening period (up to 4 weeks), a Treatment period (48 weeks), and a Follow-up period (4 weeks).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study with an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects with Active Cardiac Sarcoidosis.

Date Added
August 10th, 2022
PRO Number
Pro00122248
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

The primary objective of this study is to determine the safety and tolerability of namilumab in subjects with CS based on treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations. This study will include adult subjects with active Cardiac Sarcoidosis. Approximately 30 total subjects are planned for this study in 2 cohorts; Cohort A will enroll 20 subjects; Cohort B will enroll 10 subjects.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis.

Date Added
August 10th, 2022
PRO Number
Pro00121050
Researcher
Walter James

List of Studies


Keywords
Sarcoidosis
Summary

The primary objective of this study is to evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS). This study will include adult subjects who have been diagnosed with CPS for more than 6 months who are not well controlled by OCS and/or immunosuppressive therapy (IST). 100 total subjects are planned for this study. There will be a Double-blind treatment period of this study lasting approximately 26 weeks as well as an optional Open-Label Extension (OLE) Treatment Period which will extend the length of the study to approximately 64 weeks.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag

Date Added
December 21st, 2021
PRO Number
Pro00115070
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary, Sarcoidosis
Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational drug in adults with a clinical diagnosis of sarcoidosis-associated pulmonary hypertension. This study aims to determine if patients receiving an investigational study drug, called Selexipag, respond better than patients receiving placebo (an inactive substance). The study of this investigational drug represents a new approach to the treatment of this condition and may provide significant benefit in terms of the quality of life to patients with sarcoidosis-associated pulmonary hypertension. Participation in the study will last between approximately 15 months and up to approxiamately 3.5 years.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Date Added
December 2nd, 2021
PRO Number
Pro00107105
Researcher
Walter James

List of Studies


Keywords
Lung, Pulmonary, Sarcoidosis
Summary

Fatigue is a pervasive and disabling symptom in sarcoidosis with limited treatment options. There is a significant association between heightened stress and sarcoidosis-associated fatigue. The proposed project will evaluate the usability/feasibility of a smartphone-based stress management application for the self-managementof sarcoidosis-associated stress and fatigue.

Institution
MUSC
Recruitment Contact
Samantha Pairet
(843)996-0016
pairet@musc.edu

Right Ventricular Reserve Measures with Cardiac MRI

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

Routine Cardiac Screening in Sarcoidosis Patients

Date Added
August 20th, 2019
PRO Number
Pro00090373
Researcher
Walter James

List of Studies


Keywords
Lung, Pulmonary, Sarcoidosis
Summary

This is a trial for cardiac sarcoidosis in patients seen during routine clinical care who have not been clinically suspected to have cardiac sarcoidosis according to conventional criteria. The addition of echocardiogram and ambulatory ECG to usual clinical follow-up will be compared. This is a multicenter study, coordinated by the Foundation for Sarcoidosis Research. Up to 12 sites in the US and Europe will participate. Each site will enroll 50 consecutive consenting individuals to a total of 600 enrolled subjects in a randomized trial of additional screening versus usual care.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Human Samples Biorepository

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica del Monte

List of Studies


Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial

Date Added
June 22nd, 2017
PRO Number
Pro00067313
Researcher
Walter James

List of Studies


Keywords
Lung, Pulmonary, Sarcoidosis
Summary

You are being asked to take part in this research study because you have been diagnosed with pulmonary sarcoidosis. Sarcoidosis is a disease that can affect the lungs, skin and other organs of the body. Sarcoidosis also involves immune cells which fight bacteria. The purpose of this study is to see if using specific antibiotics will help these immune fighting cells get rid of bacterial proteins and how the antibiotics affect respiratory (breathing) function. The antibiotics used in this study are Levaquin, Ethambutol, Azithromycin, and either Rifampin or Rifabutin. You will by chance be assigned either these medicines or a placebo (an inactive substance).

Institution
MUSC
Recruitment Contact
Kelly French
843-792-3169
frenchke@musc.edu

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

Date Added
November 3rd, 2015
PRO Number
Pro00048606
Researcher
Natasha Ruth

List of Studies


Keywords
Arthritis, Autoimmune disease, Fibromyalgia, Lupus, Pediatrics, Rheumatoid, Sarcoidosis, Scleroderma
Summary

The purpose of this study is to create and maintain a registry, which is a database (a searchable collection of information) about children, adolescents and young adults with pediatric onset of rheumatic diseases. This data may help in the evaluation of the safety and benefit of medications that are prescribed to patients who have rheumatic diseases.

Institution
MUSC
Recruitment Contact
Shameeka Bowman
843-792-8317
bowm@musc.edu



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