What is the mechanism of action of this treatment?

Common treatments for Interstitial Lung Disease (ILD) include antifibrotic agents like nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the fibrotic process, such as PDGF, FGF, and VEGF receptors, thereby slowing disease progression. Pirfenidone has antifibrotic and anti-inflammatory effects, likely through the inhibition of TGF-β synthesis. These mechanisms are important for ILD patients as they can help slow lung fibrosis progression, improve lung function, and reduce acute exacerbations, ultimately enhancing the quality of life.

What side effects are associated with this type of intervention?

Nintedanib and pirfenidone are common treatments for idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD). Nintedanib is associated with side effects such as diarrhea, nausea, vomiting, liver enzyme elevation, and abdominal pain. Pirfenidone's side effects include nausea, rash, fatigue, diarrhea, and liver enzyme abnormalities. Both medications require regular monitoring due to these potential adverse effects. These side effects are important considerations for patients and healthcare providers when managing ILD.

What prior FDA approvals exist?

The FDA has approved nintedanib and pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF), a type of interstitial lung disease (ILD). Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, while pirfenidone is an antifibrotic agent that reduces fibroblast proliferation and collagen synthesis. Both drugs aim to slow disease progression and improve lung function, similar to the therapeutic goals of BI 1015550, which is currently being studied for its potential benefits in patients with progressive fibrosing interstitial lung diseases (PF-ILDs).

What other types of research exist?

Promising alternatives to BI 1015550 for ILD patients include nintedanib and pirfenidone. Nintedanib is a multikinase inhibitor that has demonstrated efficacy in slowing disease progression and reducing the rate of decline in forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone is another antifibrotic agent that has shown to improve lung function and slow disease progression in IPF patients. Both drugs have been well-studied and are considered effective options for managing ILD.

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BI 1015550 for Interstitial Lung Disease

Phase 3

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).

Patients ≥18 years old at the time of signed informed consent

Must not have

Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix

Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 31 months

Awards & highlights

Pivotal Trial

Summary

This trial tests if BI 1015550 can help adults with certain progressive lung diseases. Participants take the medicine as tablets, and their lung function is checked over time to see if it improves. The study aims to find out if this new treatment can slow down the worsening of their lung condition.

Who is the study for?

Adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) other than Idiopathic Pulmonary Fibrosis can join this study. They must have a certain level of lung function, not have had recent severe respiratory infections or lung exacerbations, and women must use effective birth control. People with recent major surgeries or certain liver issues cannot participate.

What is being tested?

The trial is testing BI 1015550 to see if it improves lung function in PF-ILD patients. Participants are randomly assigned to receive either different doses of BI 1015550 or a placebo, resembling the actual drug but without active ingredients, for up to two and a half years with regular health checks.

What are the potential side effects?

While specific side effects aren't listed here, participants' health will be monitored for any unwanted effects throughout the study period. This includes checking for any adverse reactions related to the medication or placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor confirmed I have a worsening lung condition that is not IPF.

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I am 18 years old or older.

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My doctor confirmed I have a worsening lung condition that is not IPF.

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I am using or willing to use effective birth control methods if I can have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer, except for certain skin or cervical cancers, in the last 5 years.

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I do not have HIV or hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 31 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 31 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52

Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52

Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52

+1 more

Side effects data

From 2021 Phase 2 trial • 147 Patients • NCT04419506

31%

Diarrhoea

Nasopharyngitis

Cough

Headache

Condition aggravated

Flatulence

Dyspepsia

Fatigue

Vasculitis

Constipation

Peripheral nerve paresis

Nausea

Asthenia

100%

80%

60%

40%

20%

Study treatment Arm

BI 1015550 - Antifibrotics at Baseline

Placebo - Antifibrotics at Baseline

Placebo - Non-antifibrotics at Baseline

BI 1015550 - Non-antifibrotics at Baseline

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 1015550 low doseExperimental Treatment1 Intervention

Group II: BI 1015550 high doseExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 1015550

2023

Completed Phase 2

~600

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Interstitial Lung Disease (ILD) include antifibrotic agents like nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the fibrotic process, such as PDGF, FGF, and VEGF receptors, thereby slowing disease progression. Pirfenidone has antifibrotic and anti-inflammatory effects, likely through the inhibition of TGF-β synthesis. These mechanisms are important for ILD patients as they can help slow lung fibrosis progression, improve lung function, and reduce acute exacerbations, ultimately enhancing the quality of life.

Treatment of connective tissue disease-associated interstitial lung disease: the pulmonologist's point of view.Emerging drugs for idiopathic pulmonary fibrosis.