• Chest · Nov 2018

    Randomized Controlled Trial Multicenter Study

    Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of BMS-986020, a Lysophosphatidic Acid Receptor Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis.

    • Scott M Palmer, Laurie Snyder, Jamie L Todd, Benjamin Soule, Rose Christian, Kevin Anstrom, Yi Luo, Robert Gagnon, and Glenn Rosen.
    • Division of Pulmonary and Critical Care Medicine, Duke University, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: scott.palmer@duke.edu.
    • Chest. 2018 Nov 1; 154 (5): 1061-1069.

    BackgroundIdiopathic pulmonary fibrosis (IPF) causes irreversible loss of lung function. The lysophosphatidic acid receptor 1 (LPA1) pathway is implicated in IPF etiology. Safety and efficacy of BMS-986020, a high-affinity LPA1 antagonist, was assessed vs placebo in a phase 2 study in patients with IPF.MethodsIM136003 was a phase 2, parallel-arm, multicenter, randomized, double-blind, placebo-controlled trial. Adults with IPF (FVC, 45%-90%; diffusing capacity for carbon monoxide, 30%-80%) were randomized to receive placebo or 600 mg BMS-986020 (once daily [qd] or bid) for 26 weeks. The primary end point was rate of change in FVC from baseline to week 26.ResultsOf 143 randomized patients, 108 completed the 26-week dosing phase. Thirty-five patients discontinued prematurely. Patient baseline characteristics were similar between treatment groups (placebo: n = 47; 600 mg qd: n = 48; 600 mg bid: n = 48). Patients treated with BMS-986020 bid experienced a significantly slower rate of decline in FVC vs placebo (-0.042 L; 95% CI, -0.106 to -0.022 vs -0.134 L; 95% CI, -0.201 to -0.068, respectively; P = .049). Dose-related elevations in hepatic enzymes were observed in both BMS-986020 treatment groups. The study was terminated early because of three cases of cholecystitis that were determined to be related to BMS-986020 after unblinding.ConclusionsBMS-986020 600 mg bid treatment for 26 weeks vs placebo significantly slowed the rate of FVC decline. Both regimens of BMS-986020 were associated with elevations in hepatic enzymes.Trial RegistryClinicalTrials.gov; No.: NCT01766817; URL: www.clinicaltrials.gov.Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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