{
  "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_shown": true,
  "affiliations": [
    "National Heart and Lung Institute, Imperial College London, London, UK",
    "Royal Prince Alfred Hospital and University of Sydney, Sydney, New South Wales, Australia",
    "5University of Colorado School of Medicine, Denver, Colorado, United States of America",
    "Lung Center Mainz, University Medical Center, Mainz and Marienhaus Clinic Mainz, Mainz, Germany",
    "National Reference Centre for Rare Pulmonary Diseases (Orphalung), Louis Pradel Hospital, Lyon, France",
    "Department of Oncology, Chengdu BOE Hospital, Chengdu, Sichuan, China",
    "Department of Respiratory Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands",
    "University of Massachusetts Chan Medical School/UMass Memorial Health System, Worcester, Massachusetts, USA",
    "Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan",
    "Peking Union Medical College Hospital, Beijing, China",
    "Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan",
    "Department of Conservative Dentistry and Endodontics, Datta Meghe Institute of Higher Education and Research Deemed to be University, Wardha, India",
    "Bristol Myers Squibb, Princeton, New Jersey, USA"
  ],
  "article_type": null,
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  "author_total": 14,
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      "name": "Toby M Maher"
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      "name": "Tamera J Corte"
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      "name": "Aryeh Fischer"
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      "name": "Vincent Cottin"
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      "name": "Yue Wang"
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      "name": "Marlies Wijsenbeek"
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      "name": "Fernando Martinez"
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      "name": "Takafumi Suda"
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      "name": "Zuojun Xu"
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      "name": "Aditya Patel"
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      "name": "Elizabeth Cerullo"
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    {
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        12
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      "name": "Walid Elsharkawi"
    }
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  "bibtex": "https://research.draconitic.com/paper/awnem4x7t8ahq.bib",
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  "doi": "10.1136/bmjresp-2026-004324",
  "fulltext_url": "https://bmjopenrespres.bmj.com/content/13/1/e004324.full",
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  "language": "en",
  "licence": "CC-BY",
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  "pdf_url": "https://bmjopenrespres.bmj.com/content/13/1/e004324.full.pdf",
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  "published": "2026-10-23",
  "publisher": "BMJ Publishing Group",
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  "title": "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:43:47Z",
  "url": "https://research.draconitic.com/paper/awnem4x7t8ahq",
  "venue": "BMJ Open Respiratory Research",
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