What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone. Nintedanib is known to cause side effects such as diarrhea, nausea, and liver enzyme elevations, which require regular monitoring of liver function tests. Pirfenidone commonly causes nausea, rash, and photosensitivity, and patients may also experience gastrointestinal discomfort. Both medications aim to slow disease progression and reduce acute exacerbations, but they do not cure IPF.

What prior FDA approvals exist?

The FDA has approved two primary antifibrotic agents for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a receptor blocker for multiple tyrosine kinases that mediate fibrogenic growth factors, and it has been shown to slow the rate of disease progression in IPF. Pirfenidone, on the other hand, has demonstrated efficacy in reducing the decline in forced vital capacity (FVC) and improving progression-free survival. Both drugs aim to slow the progression of lung fibrosis, similar to the investigational drug BI 1015550, which is being studied for its potential to improve lung function in IPF patients.

What other types of research exist?

Promising novel alternatives to BI 1015550 for IPF patients include: 1) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown positive results in phase 2 trials. 2) Nintedanib, an antifibrotic agent, which has demonstrated efficacy in slowing disease progression in multiple studies. 3) Pirfenidone, another antifibrotic agent, which has been shown to reduce the decline in lung function and improve survival rates in clinical trials.

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BI 1015550 for Idiopathic Pulmonary Fibrosis

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 Idiopathic Pulmonary Fibrosis (IPF)

Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method

Must not have

Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

Pivotal Trial

Summary

This trial tests a new medicine called BI 1015550 to see if it helps adults aged 40+ with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). The study checks if this medicine can improve lung function by slowing down lung damage.

Who is the study for?

Adults aged 40 or older with Idiopathic Pulmonary Fibrosis (IPF) can join this study. They may continue existing treatments with nintedanib or pirfenidone if stable for at least 12 weeks. Participants must have a certain level of lung function and women able to bear children must use effective birth control.

What is being tested?

The trial is testing BI 1015550, a new medicine for IPF, given as tablets twice daily against placebo (no active medicine). There are three groups: two different doses of BI 1015550 and one placebo group. The study lasts up to two and a half years with regular lung function tests.

What are the potential side effects?

While the specific side effects of BI 1015550 aren't listed here, common side effects in trials like this could include gastrointestinal issues, skin reactions, liver enzyme changes, fatigue, and potential risks associated with long-term medication use.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Idiopathic Pulmonary Fibrosis.

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

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I am 40 years old or older.

Exclusion Criteria

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

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I haven't had, nor do I plan to have, any major surgery within 6 weeks before or during the trial.

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I do not have HIV or hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 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

Pulmonary Fibrosis

+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 / 5Eligibility 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

Nintedanib, a tyrosine kinase inhibitor, targets pathways involved in fibrosis, such as platelet-derived growth factor and vascular endothelial growth factor. Pirfenidone inhibits TGF-beta synthesis, reducing inflammation and fibrosis. BI 1015550, a phosphodiesterase 4B inhibitor, prevents cyclic adenosine monophosphate degradation, offering antifibrotic and immunomodulatory effects. These mechanisms are vital for IPF patients as they aim to slow disease progression, improve lung function, and potentially reduce mortality.