Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF)
Methods and analysis In this placebo-controlled, double-blind, phase III trial, patients are being randomised in a 1:1:1 ratio to receive 9 mg or 18 mg of BI 1015550 or placebo two times per day over at least 52 weeks, stratified by use of background antifibrotics (nintedanib/pirfenidone vs neither)...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/10/1/e001563.full |
| _version_ | 1797371388289351680 |
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| author | Toby M Maher Michael Kreuter Vincent Cottin Susanne Stowasser Marlies S Wijsenbeek Yi Liu Fernando J Martinez Luca Richeldi Arata Azuma Justin M Oldham Claudia Valenzuela Maud Gordat Donald F Zoz |
| author_facet | Toby M Maher Michael Kreuter Vincent Cottin Susanne Stowasser Marlies S Wijsenbeek Yi Liu Fernando J Martinez Luca Richeldi Arata Azuma Justin M Oldham Claudia Valenzuela Maud Gordat Donald F Zoz |
| author_sort | Toby M Maher |
| collection | DOAJ |
| description | Methods and analysis In this placebo-controlled, double-blind, phase III trial, patients are being randomised in a 1:1:1 ratio to receive 9 mg or 18 mg of BI 1015550 or placebo two times per day over at least 52 weeks, stratified by use of background antifibrotics (nintedanib/pirfenidone vs neither). The primary endpoint is the absolute change in FVC at week 52. The key secondary endpoint is a composite of time to first acute IPF exacerbation, hospitalisation due to respiratory cause or death over the duration of the trial.Ethics and dissemination The trial is being carried out in compliance with the ethical principles of the Declaration of Helsinki, in accordance with the International Council on Harmonisation Guideline for Good Clinical Practice and other local ethics committees. The results of the study will be disseminated at scientific congresses and in peer-reviewed publications.Trial registration number NCT05321069. |
| first_indexed | 2024-03-08T18:19:06Z |
| format | Article |
| id | doaj.art-f2486a20e22e430c8654899f00c91a87 |
| institution | Directory Open Access Journal |
| issn | 2052-4439 |
| language | English |
| last_indexed | 2024-03-08T18:19:06Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj.art-f2486a20e22e430c8654899f00c91a872023-12-31T05:50:08ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392023-11-0110110.1136/bmjresp-2022-001563Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF)Toby M Maher0Michael Kreuter1Vincent Cottin2Susanne Stowasser3Marlies S Wijsenbeek4Yi Liu5Fernando J Martinez6Luca Richeldi7Arata Azuma8Justin M Oldham9Claudia Valenzuela10Maud Gordat11Donald F Zoz12Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, London, UKCentre for Interstitial and Rare Lung Diseases, Department of Pneumology, Thoraxklinik, University of Heidelberg, German Center for Lung Research, Heidelberg, Germany8 Service de Pneumologie, Centre National Coordonnateur de Référence des Maladies Pulmonaires Rares, Hôpital Louis-Pradel, Hospices Civils de Lyon (HCL), UMR754, INRAE, Université Lyon 1, ERN-LUNG, Lyon, FranceTA Inflammation Med, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, GermanyCentre for Interstitial Lung Diseases and Sarcoidosis, Department of Respiratory Medicine, Erasmus University Medical Center, Rotterdam, The NetherlandsDepartment of Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USADepartment of Medicine, Cornell University, New York City, New York, USAUnità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, ItalyPulmonary Medicine and Oncology, Nippon Medical School, Tokyo, JapanPulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USAILD Unit, Pulmonology Department, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, SpainClinical Development & Operation Department, Boehringer Ingelheim, Reims, FranceGlobal Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USAMethods and analysis In this placebo-controlled, double-blind, phase III trial, patients are being randomised in a 1:1:1 ratio to receive 9 mg or 18 mg of BI 1015550 or placebo two times per day over at least 52 weeks, stratified by use of background antifibrotics (nintedanib/pirfenidone vs neither). The primary endpoint is the absolute change in FVC at week 52. The key secondary endpoint is a composite of time to first acute IPF exacerbation, hospitalisation due to respiratory cause or death over the duration of the trial.Ethics and dissemination The trial is being carried out in compliance with the ethical principles of the Declaration of Helsinki, in accordance with the International Council on Harmonisation Guideline for Good Clinical Practice and other local ethics committees. The results of the study will be disseminated at scientific congresses and in peer-reviewed publications.Trial registration number NCT05321069.https://bmjopenrespres.bmj.com/content/10/1/e001563.full |
| spellingShingle | Toby M Maher Michael Kreuter Vincent Cottin Susanne Stowasser Marlies S Wijsenbeek Yi Liu Fernando J Martinez Luca Richeldi Arata Azuma Justin M Oldham Claudia Valenzuela Maud Gordat Donald F Zoz Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF) BMJ Open Respiratory Research |
| title | Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF) |
| title_full | Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF) |
| title_fullStr | Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF) |
| title_full_unstemmed | Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF) |
| title_short | Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF) |
| title_sort | design of a phase iii double blind randomised placebo controlled trial of bi 1015550 in patients with idiopathic pulmonary fibrosis fibroneer ipf |
| url | https://bmjopenrespres.bmj.com/content/10/1/e001563.full |
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