A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
Key facts
- Where
- Bad Berka, Berlin, Cologne, Coswig, Essen, Frankfurt am Main, Gauting, Giessen, Greifswald, Hanover, Homburg, Kiel, Leipzig, Munich és Solingen, NémetországSee the 15 sites
- Phase
- 2/3. fázis
Where in Németország
- Zentralklinik Bad Berka GmbHBad Berka, NémetországNo longer taking part
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbHBerlin, NémetországNo longer taking part
- Kliniken der Stadt Koeln gGmbHCologne, NémetországNo longer taking part
- GWT-Tud GmbHCoswig, NémetországNo longer taking part
- Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbHEssen, NémetországNo longer taking part
- IKF Pneumologie GmbH & Co. KGFrankfurt am Main, NémetországNo longer taking part
- Asklepios Klinik Gauting GmbHGauting, NémetországNo longer taking part
- Justus-Liebig-Universitaet GiessenGiessen, NémetországNo longer taking part
- Universitaetsmedizin Greifswald KöRGreifswald, NémetországNo longer taking part
- Medizinische Hochschule HannoverHanover, NémetországNo longer taking part
- Universitaet Des SaarlandesHomburg, NémetországNo longer taking part
- Universitaetsklinikum Schleswig-HolsteinKiel, NémetországNo longer taking part
- Universitaet LeipzigLeipzig, NémetországNo longer taking part
- Klinikum der Universitaet Muenchen AöRMunich, NémetországNo longer taking part
- Krankenhaus Bethanien gGmbHSolingen, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pliant Therapeutics Inc.
- Trial code
- EU 2023-506185-31-00
- Record updated
- 2025. március 6.
- Original description
To characterize the effect of bexotegrast versus placebo on the change in force vital capacity FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52Read full original descriptionShow less
To characterize the effect of bexotegrast versus placebo on the change in force vital capacity FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52
Inclusion: ≥ 40 years of age prior to screening; IPF diagnosis ≤7 years prior to screening based upon American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association 2018 guidelines and confirmed with central review (Raghu et al 2018). An HRCT scan performed ≤ 2 years prior to screening may be used for eligibility; FVCpp ≥45% confirmed with central review; Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥30% and <90% confirmed with central review; Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening.
Exclusion: Receiving pharmacologic therapy for pulmonary hypertension; Forced expiratory volume in the first second/FVC ratio <0.7 at Screening (as confirmed with central review).