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A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)

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Trial Profile

A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Feb 2026

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At a glance

  • Drugs Nerandomilast (Primary)
  • Indications Interstitial lung diseases
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 23 Feb 2026 Planned initiation date changed from 15 Jun 2026 to 6 Jul 2026.
  • 03 Feb 2026 New trial record

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