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BI 3810477 for Idiopathic Pulmonary Fibrosis

Not yet recruiting at 41 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Boehringer Ingelheim
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is for adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF). Women can only participate if they cannot get pregnant. The purpose of this study is to find out whether a medicine called BI 3810477 can slow down the worsening of lung function in people with IPF.

Participants are put into 2 groups randomly, which means by chance. One group receives BI 3810477 and the other group receives placebo. Placebo looks like BI 3810477 but does not contain any medicine. Participants receive BI 3810477 or placebo for 12 weeks. Participants may continue their regular treatment for IPF during the study.

Participants are in the study for about 6 to 7 months. During this time, they visit the study site regularly, about 18 times. Some of the visits may be done at the participant's home instead of the study site. Doctors regularly test how well the lungs work by doing lung function tests. They also look at lung scans and measure markers in the blood that are linked to lung health. The results are compared between the 2 groups to see whether BI 3810477 works. The doctors also regularly check participants' health and note any unwanted effects.

Are You a Good Fit for This Trial?

This trial is for adults aged 40 or older who have idiopathic pulmonary fibrosis (IPF). Women must not be able to become pregnant. Participants can continue their usual IPF treatment during the study.

Inclusion Criteria

Patients with forced vital capacity (FVC) ≥45% predicted at Visit 1 calculated according to Global Lung Function Initiative (GLI)
Diffusing capacity of the lung for carbon monoxide (DLCO) ≥25% and <80% of predicted normal corrected for haemoglobin at Visit 1
Further inclusion criteria apply
See 7 more

Exclusion Criteria

Other clinically significant pulmonary abnormalities per investigator opinion
There are additional reasons I may not be eligible for this trial.
I have had a recent flare-up of my lung fibrosis within the last 12 weeks.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • BI 3810477

Trial Overview

The study tests if a new medicine, BI 3810477, helps slow lung function decline in people with IPF compared to a placebo. Participants are randomly assigned to receive either BI 3810477 or placebo for 12 weeks while continuing standard care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 3810477Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

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