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

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

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

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



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