A110-14 Baseline Characteristics of Patients in the ALOFT-IPF Phase 3, Randomized, Placebo-Controlled Trial of Admilparant (BMS-986278), an Oral Lysophosphatidic Acid Receptor 1 Antagonist, in Idiopathic Pulmonary Fibrosis

Rationale Idiopathic pulmonary fibrosis (IPF) is an irreversible disease associated with progressive loss of lung function and poor prognosis, despite existing antifibrotic therapies. Admilparant (BMS-986278) is an oral lysophosphatidic acid receptor 1 antagonist in development for treatment of IPF and progressive pulmonary fibrosis. We present the baseline characteristics of patients enrolled in the ongoing ALOFT-IPF phase 3 trial, which aims to evaluate the safety, tolerability, and efficacy of admilparant over 52 weeks in patients with IPF. Methods ALOFT-IPF (NCT06003426) is a multicenter, randomized, placebo-controlled trial being conducted in 32 countries. Using a 2-cohort design, adults (age ≥40 years) with IPF are randomized to receive admilparant 60 or 120 mg or placebo (1:1:1) orally, twice daily for ≥52 weeks, stratified by concurrent antifibrotic therapy (nintedanib vs pirfenidone vs none) and sex. Other key inclusion criteria are IPF diagnosis within 7 years, percent of predicted forced vital capacity (ppFVC) ≥40%, and percent of predicted diffusing capacity of the lung for carbon monoxide (ppDLCO) ≥25%. Cohort 1 enrolled patients to evaluate the safety and tolerability of admilparant after 4 weeks of treatment; based on data evaluation, continuation of the trial is permitted without change. Subsequent patients are recruited into cohort 2, a registrational, double-blind design to evaluate the safety and efficacy of admilparant versus placebo. The primary endpoint for cohort 2 is absolute change in FVC from baseline to week 52. Results ALOFT-IPF enrollment is complete. Between September 14, 2023, and September 5, 2025, 1251 patients with IPF were randomized and received ≥1 dose of study drug (cohort 1, N = 60; cohort 2, N = 1191; Table). Overall, 42.5% of patients were enrolled from Asia-Pacific countries, 23.6% from Europe, 18.2% from North America, and 15.7% from Latin America. Median (interquartile range; IQR) age was 71.0 (66.0-75.0) years, 79.4% were male, and 57.7% were White. Overall, 64.1% of patients were receiving background antifibrotics at baseline; the median (IQR) time since diagnosis was 2.1 (1.0-3.9) years. Baseline median FVC was 2710 (2200-3230) mL, and percent predicted FVC and DLCO were 78.9% and 51.9%, respectively. Conclusion Patients enrolled in the ALOFT-IPF trial are generally representative of people with IPF and are similar to other recent phase 3 trials, consisting of adults with advanced age, a preponderance of males and, on average, moderately impaired lung function. ALOFT-IPF will assess the impact of treatment with admilparant for up to 3 years in a typical population of patients with IPF.