Fibroneer ILD - A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases

Interstitial lung disease

Interstitial lung disease (ILD) is a group of diseases which that cause scarring of the lungs. The scarring causes lung stiffness which can make it difficult to breathe. Common symptoms include shortness of breath, dry cough, chest discomfort, fatigue and occasionally weight loss.  Lung damage from ILDs is usually permanent, so available treatments aim to relieve symptoms, improve quality of life and slow disease progression. 

BI 1015550 is a new anti-inflammatory drug which was developed to improve outcomes in diseases associated with tissue scarring, including ILDs.  This clinical trial tests whether the addition of BI 1015550 to standard care helps to reduce the decline in lung function in people with ILD.  Participants in the study will be randomly assigned to receive the study drug plus standard care or placebo plus standard care. 

Category
Trial Status
Recruiting
Trial Phase
Phase 3 Drug Trial
Trial contact details
Contact Person
RIO Clinical Trials Unit
What you need to know

Who can take part?

You may participate in this study if you:

  • Have been diagnosed with progressive fibrosing interstitial lung disease (ILD)
  • Are 18 years of age or older

You may not participate in the study if you:

  • Developed ILD as a result of COVID-19 infection in the last 12 months
  • Have certain infections or health conditions which the study doctor will discuss with you

What is involved for you?

Participants in the study will undertake the following assessments, tests and procedures:

  • Medical history
  • Health questionnaires
  • Physical exam
  • Electrocardiogram
  • Lung function test
  • Blood tests
  • Women who can have children must take pregnancy tests
  • Take two oral tablets twice a day containing study drug or placebo for one year

Trial dates

March 2023 to November 2023

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