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A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment

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Trial Profile

A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 11 Jan 2022

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At a glance

  • Drugs Nintedanib (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Biomarker; Pharmacodynamics
  • Acronyms INMARK; PROFILE
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 08 Jan 2021 Results published in the European Respiratory Journal
  • 20 May 2020 Results presented at the 116th International Conference of the American Thoracic Society
  • 20 May 2020 Results (n=1690) of pooled analysis of five studies (TOMORROW, INPULSIS-1, 2, INMARK & NCT01979952) assessing efficacy and safety of nintedanib in patients with IPF and multiple comorbidities in < vs ≥5 comorbidities sub-groups, presented at the 116th International Conference of the American Thoracic Society.

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