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A Double Blind, Randomised, Placebo-controlled Trial to Evaluate the Dose-exposure and Safety of Nintedanib Per os on Top of Standard of Care for 24 Weeks, Followed by Open Label Treatment With Nintedanib of Variable Duration, in Children and Adolescents (6 to 17 Year-old) With Clinically Significant Fibrosing Interstitial Lung Disease

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Trial Profile

A Double Blind, Randomised, Placebo-controlled Trial to Evaluate the Dose-exposure and Safety of Nintedanib Per os on Top of Standard of Care for 24 Weeks, Followed by Open Label Treatment With Nintedanib of Variable Duration, in Children and Adolescents (6 to 17 Year-old) With Clinically Significant Fibrosing Interstitial Lung Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2024

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At a glance

  • Drugs Nintedanib (Primary)
  • Indications Interstitial lung diseases
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms InPedILD; InPedILD&TRADE
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 25 Jul 2023 According to a Boehringer Ingelheim Media Release, based on results from this study the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for OFEV (nintedanib), investigating a potential treatment for children and adolescents between 6 to 17 years old with fibrosing interstitial lung disease
  • 24 May 2023 Results assessing effect of nintedanib in adults to estimate the effect of nintedanib on FVC in children and adolescents, presented at the 119th International Conference of the American Thoracic Society.
  • 05 Sep 2022 According to a Boehringer Ingelheim Media Release, based on results from this study regulatory applications will be submitted to the European Medicines Agency and U.S. Food and Drug Administration.

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