Protocol and rationale for a randomised, double-blind, placebo-controlled phase 3 trial of admilparant (BMS-986278), an oral lysophosphatidic acid receptor 1 antagonist, in patients with idiopathic pulmonary fibrosis: ALOFT-IPF
In brief
Phase 3 trial tests admilparant against placebo in 1,191 with idiopathic pulmonary fibrosis
The global trial is testing two doses of admilparant, taken twice daily, against placebo in 1,191 people with idiopathic pulmonary fibrosis, with background antifibrotic treatment allowed. The main measure is change in lung capacity after 52 weeks; a phase 2 study found slower lung-function decline, but this trial has not yet reported whether that benefit holds up.
- Journal
- BMJ open respiratory research (Q1)
- Published
- 9 October 2026
- Study design
- Phase 2 randomized trial (exploratory)
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Toby M Maher, Fernando Martinez, Michael Kreuter, Tamera J Corte, Marlies Wijsenbeek, Takashi Ogura, et al.
- PMID
- 42869508
- DOI
- 10.1136/bmjresp-2026-004324
Why clinicians should know about it
- Picked for Pulmonary and Respiratory Medicine (paper of the day, 16 October 2026): admilparant phase 3 trial design for idiopathic pulmonary fibrosis
Abstract
Introduction Idiopathic pulmonary fibrosis (IPF) is associated with progressive loss of lung function and poor prognosis. There remains a need for novel therapies for patients with IPF. Admilparant, an oral lysophosphatidic acid receptor 1 antagonist, slowed lung function decline and was well tolerated in a phase 2 trial when administered 60 mg two times per day in patients with IPF over 26 weeks. This report describes the design and rationale of the pivotal ALOFT-IPF phase 3 trial, which aims to further evaluate admilparant for patients with IPF.Methods and analysis ALOFT-IPF, a global, phase 3, multicentre, randomised, double-blind, placebo-controlled clinical trial, completed enrolment on 5 September 2025. Adults (≥40 years) with IPF were randomised to receive admilparant 60 mg or 120 mg or placebo (1:1:1) orally, two times per day for ≥52 weeks. Inclusion criteria included IPF diagnosis within 7 years, percentage of predicted forced vital capacity ≥40% and percentage of predicted diffusing capacity of the lung for carbon monoxide ≥25%. Background antifibrotic treatment was permitted. Randomisation was stratified by antifibrotic therapy and sex. A two-cohort design was used to assess the safety of admilparant 120 mg. Cohort 1 (n=60), a single-blind design, evaluated safety and tolerability of admilparant; the primary endpoint was the number of spontaneous syncopal episodes after 4 weeks. Based on data evaluation, continuation of the trial was permitted without change and recruitment into cohort 2 initiated. Cohort 2 (n=1191) has a registrational, double-blind design to evaluate the efficacy, safety and tolerability of admilparant compared with placebo; the primary endpoint is absolute change in forced vital capacity from baseline at week 52. The trial is estimated to complete in October 2026.Ethics and dissemination This trial is being conducted in accordance with the protocol and international guidelines, applicable local laws, regulations and requirements.Trial registration number NCT06003426.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.