Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF)

There is an unmet need for new treatments for idiopathic pulmonary fibrosis (IPF). The oral preferential phosphodiesterase 4B inhibitor, BI 1015550, prevented a decline in forced vital capacity (FVC) in a phase II study in patients with IPF. This study design describes the subsequent pivotal phase I...

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Main Authors: Richeldi, Luca (Author) , Azuma, Arata (Author) , Cottin, Vincent (Author) , Kreuter, Michael (Author) , Maher, Toby M. (Author) , Martinez, Fernando J. (Author) , Oldham, Justin M. (Author) , Valenzuela, Claudia (Author) , Gordat, Maud (Author) , Liu, Yi (Author) , Stowasser, Susanne (Author) , Zoz, Donald F. (Author) , Wijsenbeek, Marlies S. (Author)
Format: Article (Journal)
Language:English
Published: August 18, 2023
In: BMJ Open Respiratory Research
Year: 2023, Volume: 10, Pages: 1-8
ISSN:2052-4439
DOI:10.1136/bmjresp-2022-001563
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1136/bmjresp-2022-001563
Verlag, kostenfrei, Volltext: https://bmjopenrespres.bmj.com/content/10/1/e001563
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Author Notes:Luca Richeldi, Arata Azuma, Vincent Cottin, Michael Kreuter, Toby M. Maher, Fernando J. Martinez, Justin M. Oldham, Claudia Valenzuela, Maud Gordat, Yi Liu, Susanne Stowasser, Donald F. Zoz, Marlies S. Wijsenbeek
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Summary:There is an unmet need for new treatments for idiopathic pulmonary fibrosis (IPF). The oral preferential phosphodiesterase 4B inhibitor, BI 1015550, prevented a decline in forced vital capacity (FVC) in a phase II study in patients with IPF. This study design describes the subsequent pivotal phase III study of BI 1015550 in patients with IPF (FIBRONEER-IPF).
Item Description:Gesehen am 28.11.2023
Physical Description:Online Resource
ISSN:2052-4439
DOI:10.1136/bmjresp-2022-001563