A Double Blind, Randomized, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Nintedanib Over 52 Weeks In Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Save

Date Added
August 22nd, 2017
PRO Number
Pro00068850
Researcher
John Huggins
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to see how well the study drug called nintedanib may help lung disease and to compare its safety and effects with a placebo in subject with PF-ILD.

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@musc.edu

A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ?Systemic Sclerosis associated Interstitial Lung Disease?(SSc-ILD) Save

Date Added
November 24th, 2015
PRO Number
Pro00049621
Researcher
John Huggins
Keywords
Drug Studies, Lung, Pulmonary
Summary

This study will evaluate the safety and effects of using nintendanib over 18 months in subjects with systemic sclerosis (SSc) and associated Interstitial Lung Disease 18 years old and older.This study will also see if treatment with nintedanib for SSc can slow the rate of lung scarring (fibrosis).

Institution
MUSC
Recruitment Contact
Farah Stokes
843-792-0373
flaitz@musc.edu

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Save

Date Added
February 11th, 2014
PRO Number
Pro00027891
Researcher
John Huggins
Keywords
Pulmonary
Summary

The purpose of this study is to find out what effects, good or bad, lebrikizumab or placebo treatment has on the subject and IPF.

Lebrikizumab is an antibody that is dissolved in a solution like water that can be injected under skin. This type of injection is known as a subcutaneous injection. Lebrikizumab attaches to interleukin-13 (IL-13 for short). Many doctors believe IL-13 plays a part in IPF. Blocking IL-13 might slow down lung fibrosis and prevent the disease from getting worse, but this is unknown at this time.
The study will examine whether or not lebrikizumab reduces the loss of lung function, the need for hospitalization, or death caused by IPF compared with the placebo solution. The placebo is made of the same liquid solution that lebrikizumab is dissolved in but contains no protein or drug. Placebo is not expected to provide any benefit for IPF. The study team will also examine whether or not treatment with lebrikizumab has an effect on symptoms of IPF like shortness of breath, as well as what negative effects the drug may have on patients with IPF. The study is also studying whether a new blood test to measure the level of a protein in blood called periostin can be used to determine which patients are more likely to benefit from lebrikizumab treatment.

Institution
MUSC
Recruitment Contact
Jordan Parker
843-792-6648
parkerjo@musc.edu

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