Pneumologie 2023; 77(S 01): S93-S94
DOI: 10.1055/s-0043-1761096
Abstracts

Design of Phase III, Randomized, Placebo-Controlled Trials of BI 1015550 in Patients with Progressive Fibrosing Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis (FIBRONEER-ILD / -IPF)

Autoren

  • M Kreuter

    1   Zentrum für Interstitielle und Seltene Lungenerkrankungen, Pneumologie und Beatmungsmedizin, Thoraxklinik; Universitätsklinikum Heidelberg und Translationales Zentrum für Lungenforschung Heidelberg (Tlrc); Mitglied des Deutschen Zentrums für Lungenforschung (Dzl)

  • T Maher

    2   Keck Medicine of Usc, Los Angeles, Ca, USA

  • A Azuma

    3   Pulmonary Medicine and Oncology, Nippon Medical School, Tokyo, Japan

  • V Cottin

    4   Hôpital Louis Pradel, Centre de Reference des Maladies Rares Pulmonaires, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France

  • S Assassi

    5   Department of Rheumatology and Clinical Immunogenetics, Mcgovern Medical School, University of Texas, Houston, TX, USA

  • A Hoffmann-Vold

    6   Department of Rheumatology, Oslo University Hospital, Oslo, Norway

  • F Martinez

    7   Department of Medicine, Cornell University, New York City, Ny, USA

  • J Oldham

    8   University of Michigan, Pulmonary and Critical Care Medicine, Ann Abor, MI, United States

  • C Valenzuela

    9   Ild Unit, Pulmonology Department, Hospital Universitario de la Princesa, University Autonomade Madrid, Madrid, Spain

  • M Wijsenbeek

    10   Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, The Netherlands

  • Y Liu

    11   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Ct, USA

  • D Wachtlin

    12   Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein, Germany

  • S Stowasser

    13   Ta Inflammation Med, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany

  • D Zoz

    11   Boehringer Ingelheim Pharmaceuticals, Ridgefield, Ct, USA

  • L Richeldi

    14   Unità Operativa Complessa DI Pneumologia, Fondazione Policlinico Universitario A. Gemelli Irccs, Università Cattolica del Sacro Cuore, Rome, Italy
Weitere Informationen
Auch verfügbar auf
 

Background/Purpose There is a need for better treatments that modify the disease course and improve symptoms of idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing interstitial lung diseases (PF-ILD). BI 1015550, a preferential phosphodiesterase 4B inhibitor, prevented lung function decline in a Phase II study in IPF. Based on its anti-inflammatory and antifibrotic properties it may provide an additional treatment option, alone or with nintedanib, in patients with IPF or PF-ILD.

Methods We describe the design of the FIBRONEER-ILDTM and FIBRONEER-IPF™ trials, two randomized, placebo-controlled, Phase III studies evaluating the efficacy and safety of BI 1015550 in patients with PF-ILD (NCT05321082) or with IPF (NCT05321069). Patients will be randomized in a 1:1:1 ratio to either BI 1015550 18 mg twice daily (BID), 9 mg BID, or placebo in addition to standard of care, over at least 52 weeks ([Figure 1]). The primary endpoint is the absolute change from baseline in FVC (mL) at Week 52. The key secondary endpoint is the time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death, over the duration of the trial. FIBRONEER-ILDTM will be stratified by HRCT pattern (UIP vs other fibrotic pattern), and by baseline use of nintedanib (yes/no); FIBRONEER-IPF™ by the presence or absence of background treatment with antifibrotics ([Fig. 2]).

Zoom
Fig. 1 Study design schematic.
Zoom
Fig. 2 Main inclusion and exclusion criteria

Results In Germany the trials are planned to be conducted in 70 patients each at 25 study sites, with a recruitment start in Q.4/2022 and a planned completion date in March 2025.

Conclusion The FIBRONEER-ILDTM and FIBRONEER-IPF™ trials are designed to investigate the potential use of BI 1015550 as a treatment option for patients with non-IPF progressive fibrosing ILDs or IPF, respectively, with and without background antifibrotic medication.

Funding The studies are sponsored by Boehringer Ingelheim International GmbH



Publikationsverlauf

Artikel online veröffentlicht:
09. März 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag
Rüdigerstraße 14, 70469 Stuttgart, Germany