Pirfenidone + BI 1015550 for Idiopathic Pulmonary Fibrosis

Not yet recruiting at 2 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Pirfenidone

Disqualifiers: Liver cirrhosis, Cardiovascular diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the interaction of two medicines, pirfenidone and BI 1015550 (a new potential drug), in individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. Participants will take these medications in a specific order to determine if one affects the blood levels of the other. The study aims to ensure the medicines work well together without causing unwanted effects. The trial seeks adults with IPF who are eligible for pirfenidone treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in IPF treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BI 1015550 is generally safe for people with idiopathic pulmonary fibrosis (IPF). One study found it safe for both healthy individuals and those with IPF, indicating that most participants tolerated the treatment well.

Pirfenidone, a treatment already used for IPF, has a well-established safety record. Studies indicate it effectively slows the disease's progression. While some side effects may occur, they are usually manageable with a doctor's assistance.

Both BI 1015550 and pirfenidone have demonstrated promising safety results in past studies, making them suitable candidates for further research together. Always consult your healthcare provider to understand what this means for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for idiopathic pulmonary fibrosis, like nintedanib and pirfenidone, aim to slow down lung damage by inhibiting pathways that lead to fibrosis. However, researchers are excited about BI 1015550 because it introduces a novel mechanism, acting as a PDE4B inhibitor. This action potentially addresses inflammation and fibrosis more directly. When combined with pirfenidone, this dual approach might enhance the overall effectiveness, offering a promising new angle to tackle the progression of this challenging condition.

What evidence suggests that this trial's treatments could be effective for idiopathic pulmonary fibrosis?

Previous studies have shown that BI 1015550 holds promise for treating idiopathic pulmonary fibrosis (IPF) by preventing lung deterioration. It blocks a specific enzyme, potentially slowing the disease. Research has also found that another medicine, Pirfenidone, slows the disease in IPF patients, reducing the risk of lung function decline and improving overall survival chances. In this trial, participants will initially receive BI 1015550, followed by a combination of Pirfenidone and BI 1015550. Both medicines have proven effective in managing IPF symptoms and slowing the disease's progression. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 40+ with idiopathic pulmonary fibrosis (IPF) can join this study if they have a BMI of 18.5-29.9 kg/m^2 and are suitable for pirfenidone treatment as per the doctor's assessment. Women must use effective birth control, and all participants need to consent to the trial's procedures.

Inclusion Criteria

I am 40 years old or older.

I can and will use effective birth control if I'm able to have children.

My BMI is between 18.5 and 29.9.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take one dose of BI 1015550, followed by pirfenidone tablets with increasing doses over three weeks, and then another dose of BI 1015550

3 weeks

15 visits (in-person), including 2 overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1015550
• Pirfenidone

Trial Overview

The trial tests how pirfenidone affects the blood levels of BI 1015550 in IPF patients. Participants take BI 1015550 once, followed by increasing doses of pirfenidone over three weeks, then another dose of BI 1015550. The study lasts just over a month with frequent health checks.

How Is the Trial Designed?

Group I: BI 1015550, then Pirfenidone + BI 1015550 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36537726/

Plain language summary: Clinical study of BI 1015550 as a ...

These results provide evidence that BI 1015550 prevents lung function from worsening in people with IPF. Further clinical studies will be ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04419506

A Study to Test How Taking BI 1015550 for 12 Weeks ...

The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function.

3.

boehringer-ingelheim.com

boehringer-ingelheim.com/us/human-health/topline-results-boehringers-phase-iii-ipf-study

Topline results from Boehringer's Phase III IPF Study

(2023) Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis ( ...

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2201737

Trial of a Preferential Phosphodiesterase 4B Inhibitor for ...

In this phase 2, double-blind, placebo-controlled trial, we investigated the efficacy and safety of BI 1015550, an oral preferential inhibitor of the PDE4B ...

5.

pulmonologyadvisor.com

pulmonologyadvisor.com/news/efficacy-safety-of-ipf-treatment-with-bi-1015550/

Efficacy/Safety of Idiopathic Pulmonary Fibrosis Treatment ...

Treatment of patients with IPF with BI 1015550, with or without an antifibrotic agent, prevented a decrease in lung function.

6.

boehringer-ingelheim.com

boehringer-ingelheim.com/us/human-health/lung-diseases/pulmonary-fibrosis/fda-grants-bi-1015550-breakthrough-therapy-designation-idiopathic-pulmonary-fibrosis

FDA Grants BI 1015550 Breakthrough Therapy ...

Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022; Boehringer Ingelheim plans to study this ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05321069

NCT05321069 | A Study to Find Out Whether BI 1015550 ...

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9589333/

Phase I studies of BI 1015550, a preferential ... - PMC

BI 1015550 had an acceptable safety profile in healthy male subjects and male and female patients with IPF, supporting further development in larger trials.