@article{Wuyts:2026:10.1136/bmjresp-2024-002937,
author = {Wuyts, WA and Lancaster, L and Maher, TM and Ryerson, CJ and Kreuter, M and Corte, TJ and Valenzuela, C and Barnes, CN and Lefebvre, ÉA and Cosgrove, GP and Flaherty, KR and Richeldi, L and Cottin, V},
doi = {10.1136/bmjresp-2024-002937},
journal = {BMJ Open Respir Res},
title = {Bexotegrast for treatment of idiopathic pulmonary fibrosis (BEACON-IPF): study protocol for a multinational, phase 2b/3, double-blind, randomised, multicentre, controlled trial.},
url = {http://dx.doi.org/10.1136/bmjresp-2024-002937},
volume = {13},
year = {2026}
}

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TY  - JOUR
AB  - INTRODUCTION: Bexotegrast is an oral, once-daily, dual-selective inhibitor of integrins αvβ6 and αvβ1 in development for idiopathic pulmonary fibrosis (IPF). In the phase 2a study INTEGRIS-IPF study (NCT04396756), bexotegrast was well tolerated and showed antifibrotic activity. METHODS AND ANALYSIS: BEACON-IPF (NCT06097260) is a randomised, double-blind, placebo-controlled, dose-finding, operationally seamless, adaptive phase 2b/3 study evaluating the efficacy and safety of bexotegrast over 52 weeks in participants with IPF. The phase 2b dose selection cohort will enrol 360 participants randomised 1:1:1 to once-daily bexotegrast 160 mg, 320 mg or placebo. After enrolling the last participant in the phase 2b cohort and while conduct is ongoing, the phase 3 cohort will immediately begin enrolment with a 'seamless group' using the same 1:1:1 randomisation. Once the phase 2b cohort has completed and a dose has been selected, the remainder of the phase 3 cohort will be enrolled. Participants in the phase 2b cohort receiving the non-selected dose will be eligible for an open-label study at the selected phase 3 dose. Background therapy with pirfenidone or nintedanib is permitted in ≤70% of the study population. Participants must be adults (≥40 years), have an IPF diagnosis ≤7 years per 2018 international guidelines, per cent predicted forced vital capacity (FVCpp) ≥45% and diffusing capacity for carbon monoxide (haemoglobin adjusted) ≥30%. The primary endpoint is change from baseline in absolute FVC at week 52. Additional endpoints include safety and tolerability, time to disease progression, participant-reported symptom assessments and quantitative lung fibrosis extent. ETHICS AND DISSEMINATION: This study was approved by Advarra institutional review board (IRB; OHRP and Food and Drug Administration registration 00000971) and at each participating site by IRBs and local ethics review committees. Participants will p
AU  - Wuyts,WA
AU  - Lancaster,L
AU  - Maher,TM
AU  - Ryerson,CJ
AU  - Kreuter,M
AU  - Corte,TJ
AU  - Valenzuela,C
AU  - Barnes,CN
AU  - Lefebvre,ÉA
AU  - Cosgrove,GP
AU  - Flaherty,KR
AU  - Richeldi,L
AU  - Cottin,V
DO  - 10.1136/bmjresp-2024-002937
PY  - 2026///
TI  - Bexotegrast for treatment of idiopathic pulmonary fibrosis (BEACON-IPF): study protocol for a multinational, phase 2b/3, double-blind, randomised, multicentre, controlled trial.
T2  - BMJ Open Respir Res
UR  - http://dx.doi.org/10.1136/bmjresp-2024-002937
UR  - https://www.ncbi.nlm.nih.gov/pubmed/41807015
VL  - 13
ER  - 

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