1199.227 Effect of nintedanib on biomarkers

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  203066

• Contact name

  Toby Maher

• Contact email

  t.maher@imperial.ac.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2015-003148-38

• Duration of Study in the UK

  1 years, 10 months, 11 days

• Research summary

  This study aims to assess the effect of nintedanib on a biomarker (a molecule found in the blood) which is associated with disease progression in patients with Idiopathic Pulmonary Fibrosis.

  The main criteria a patient must satisfy to be eligible for the trial are:
  - Provide written informed consent
  - Male or female patients aged ≥40 years
  - IPF diagnosed within the last 3 years and confirmed by a chest scan within the last 18 months and surgical lung biopsy (if available)
  - Forced Vital Capacity (FVC - a measurement of lung function) is ≥80% of predicted normal.

  A total of approximately 350 patients will be treated on the study. Each patient will first go through the screening period (lasting around 2 weeks) during which eligibility for study participation is established. There is then a 52 week treatment period. Patients will be randomised to receive either nintedanib (117 patients) or placebo (233 patients) for 12 weeks. Then, for the remaining 40 weeks of the treatment period, all patients will receive nintedanib. After the treatment period is finished patients will be followed up for another 4 weeks. Each patient's participation in the trial is estimated to last approximately 58 weeks in total.

  The study will be conducted in hospitals. Additional testing will include routine safety procedures such as safety laboratory testing and vital signs measurement.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/0793

• Date of REC Opinion

  6 Jun 2016

• REC opinion

  Further Information Favourable Opinion