Abstract
What is this summary about?
Two ongoing clinical studies are part of a programme called FIBRONEER. The FIBRONEER studies are testing the drug BI 1015550 as a treatment for people with idiopathic pulmonary fibrosis (IPF) and people with progressive pulmonary fibrosis (PPF).
IPF is a severe lung disease where scar tissue builds up in the lungs. The ‘idiopathic’ part means that doctors do not know the cause of the lung scarring. PPF is a general term to describe the worsening of lung scarring in any disease where scar tissue forms in the lungs, both from known causes such as other underlying diseases and for unknown reasons. While IPF can be considered to be a typical form of worsening lung scarring, in clinical studies, IPF and PPF are usually considered separately. In both IPF and PPF, scar tissue builds up in the lungs, making them smaller and no longer able to take in oxygen well. This leads to difficulty in breathing and getting oxygen to the tissues, making it difficult to perform daily activities and reducing the patient's quality of life.
The symptoms and outcomes of PPF are often similar to IPF.
What study drug is being investigated?
BI 1015550 is a new study drug being developed to reduce scarring in the lungs in IPF and PPF. In the FIBRONEER studies, some participants are taking BI 1015550 and others are taking placebo. The placebo looks identical to BI 1015550 but does not contain any medicine. Researchers will compare the study drug to placebo to find out how well the study drug works. Participants may also take another approved medicine to treat their lung scarring. The FIBRONEER studies are investigating the effects of BI 1015550 alone and in combination with any existing medicines the participants are taking. The goal is to see whether BI 1015550 can slow down or stop a decline in lung function in people with IPF and PPF, and how well it is tolerated.
Clinical Trial Registration: NCT05321069 FIBRONEER-IPF, NCT05321082 FIBRONEER-ILD (ClinicalTrials.gov)
Two clinical studies are testing the drug BI 1015550 as a new treatment for people with idiopathic pulmonary fibrosis (FIBRONEER-IPF) or progressive pulmonary fibrosis (FIBRONEER ILD). The studies are taking place in up to 44 countries across North, South and Central America, Europe, Africa, Asia and Australasia.
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Writing disclosure
Darren Chow, MSc, of Nucleus Global, UK, provided writing, editorial support and formatting assistance, which was contracted and funded by Boehringer Ingelheim.
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Acknowledgments
The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The authors did not receive payment related to the development of the manuscript. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Financial & competing interests disclosure
LR has received research grants from Boehringer Ingelheim and the Italian Medicine Agency; been an advisory board member for Roche, Boehringer Ingelheim, FibroGen and Promedior; been involved in consulting activity for Biogen, Celgene, Nitto, Pliant Therapeutics, Toray, Bristol Myers Squibb, Respivant and CSL Behring; received payment for lectures from Boehringer Ingelheim, Zambon and Cipla; received support for attending meetings from Boehringer Ingelheim and Roche; and been a steering committee member for Boehringer Ingelheim and Roche.
SA has received research grants from Boehringer Ingelheim, Momenta and Janssen; and consulting fees from Boehringer Ingelheim, Novartis, AbbVie, CSL Behring, AstraZeneca, and aTyr Pharma.
AMHV has received research grants from Boehringer Ingelheim and Janssen; speaker fees from Boehringer Ingelheim, Janssen, Lilly, Medscape, Merck Sharp & Dohme and Roche; and consulting fees from ARXX, Bayer, Boehringer Ingelheim, Genentech, Janssen, Medscape and Roche.
AA has received research grants and speaker fees from Boehringer Ingelheim and Taiho Pharm. Co.; and been advisory committee member for Boehringer Ingelheim, Taiho Pharm. Co., Toray Medical Co. and Kyorin Pharm. Co.
VC has received unrestricted grants from Boehringer Ingelheim; consulting fees from Boehringer Ingelheim, Roche, Galapagos, Shionogi, RedX, Pure Tech, Celgene/BMS, AstraZeneca, CSL Behring, Ferrer and Sanofi; lecture fees from Boehringer Ingelheim and Roche; support for attending meetings from Boehringer Ingelheim and Hoffmann-La Roche; has participated in data and safety monitoring boards for Roche, Galapagos and Galecto; and been on an adjudication committee for FibroGen.
MK is an advisor or review panel member for Boehringer Ingelheim, Galapagos and Roche; and has received consultancy fees, grants and speaker fees from Boehringer Ingelheim and Roche.
TMM has received consulting fees from Boehringer Ingelheim, Roche/Genentech, AstraZeneca, Bayer, Blade Therapeutics, Bristol Myers Squibb, Galapagos, Galecto, GlaxoSmithKline, IQVIA, Pliant, Respivant, Theravance and Veracyte. He has also received speaker fees from Boehringer Ingelheim and Roche/Genentech.
FJM has served on a steering committee, advisory board, data safety monitoring board or adjudication committee for Afferent/Merck, Bayer, Biogen, Boehringer Ingelheim, Nitto, Respivant, Roche and Veracyte; and has received consulting fees or payment for presentations from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Bridge Biotherapeutics, CSL Behring, DevPro, IQVIA, Roche/Genentech, Sanofi, Shionogi, twoXAR, United Therapeutics and Veracyte.
JMO has received consultancy fees and grants from Boehringer Ingelheim; and consultancy fees from Roche/Genentech and Lupin Pharmaceuticals.
DW, YL, SS and DFZ are employees of Boehringer Ingelheim.
CV has received personal fees from Boehringer Ingelheim, Hoffmann-La Roche and Bristol Myers Squibb; and support for attending meetings from Boehringer Ingelheim and Hoffmann-La Roche.
MSW has received grants from Boehringer Ingelheim, Hoffmann-La Roche, AstraZeneca-Daiichi, The Netherlands Organisation for Health Research and Development, The Dutch Lung Foundation and The Dutch Pulmonary Society; consulting fees from Boehringer Ingelheim, Galapagos, Bristol Myers Squibb, Galecto, Respivant, NeRRe Therapeutics, Horizon Therapeutics, PureTech health, Kinevant Sciences, Molecure and CSL Behring; speaker fees from Boehringer Ingelheim, Hoffmann-La Roche, Novartis and CSL Behring; support for attending meetings from Boehringer Ingelheim, Galapagos and Hoffmann-La Roche; and has participated in advisory boards for Dutch lung fibrosis and sarcoidosis patient associations (unpaid). All grants and fees were paid to her institution. The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.