Bexotegrast for treatment of idiopathic pulmonary fibrosis (BEACON-IPF): study protocol for a multinational, phase 2b/3, double-blind, randomised, multicentre, controlled trial - PubMed

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Bexotegrast is an oral, dual-selective inhibitor of integrins αvβ6 and αvβ1 being developed for idiopathic pulmonary fibrosis (IPF).
BEACON-IPF is a phase 2b/3 randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of bexotegrast over 52 weeks in IPF patients.
The study will enroll 360 participants in the phase 2b cohort, randomized to receive bexotegrast 160 mg, 320 mg, or placebo.
Participants must be adults (≥40 years) with an IPF diagnosis ≤7 years, FVCpp ≥45%, and DLCO ≥30%.
Primary endpoint: Change from baseline in absolute forced vital capacity (FVC) at week 52.
Secondary endpoints include safety, disease progression, symptom assessments, and lung fibrosis extent.
Background therapy with pirfenidone or nintedanib is permitted in ≤70% of participants.
Results will be disseminated in peer-reviewed journals and conferences.

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