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Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD

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Trial Profile

Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Pirfenidone (Primary)
  • Indications Interstitial lung diseases
  • Focus Registrational; Therapeutic Use
  • Sponsors Roche; Roche Farma

    • Most Recent Events

    • 22 Dec 2021 Results of subgroup analysis assessing the effects of immunomodulators (concomitant mycophenolate mofetil [MMF]and/or previous corticosteroids) with pirfenidone in patients with uILD published in the Advances in Therapy
    • 21 Jan 2021 According to a Genentech media release, U.S. Food and Drug Administration (FDA) has accepted the companys supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.The sNDA is based on results from this trial.
    • 20 May 2020 Results (n=45) of subgroup analysis evaluating benefit from pirfenidone stratified by concomitant Mycophenolate Mofetil (MMF) Use, presented at the 116th International Conference of the American Thoracic Society
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