BI 1015550 for Pulmonary Fibrosis

(FIBRONEER™-ON Trial)

Recruiting in Palo Alto (17 mi)

+389 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Boehringer Ingelheim

Must be taking: Nerandomilast

Disqualifiers: Suicidality, Severe depression, Malignant neoplasm, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550 (study 1305-0014 or 1305-0023). The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Will I have to stop taking my current medications?

The trial allows participants to continue their regular treatment for pulmonary fibrosis during the study. However, if you are taking any restricted medications or drugs that might interfere with the trial, you may need to stop those. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug BI 1015550 for pulmonary fibrosis?

The BI 1015550 drug was tested in a trial for idiopathic pulmonary fibrosis (IPF) and showed positive results in improving lung function, as measured by forced vital capacity (FVC), over 12 weeks. This suggests it may help slow the progression of lung scarring in IPF patients. ^{1 2 3 4 5}

Is BI 1015550 safe for humans?

BI 1015550 has been studied for safety in both healthy individuals and patients with idiopathic pulmonary fibrosis (IPF). The studies looked at how well people tolerated the drug and monitored any additional medical issues (adverse events) that occurred during the trials. ^{1 6 7 8 9}

How is the drug BI 1015550 different from other treatments for pulmonary fibrosis?

BI 1015550, also known as Nerandomilast, is unique because it is a phosphodiesterase 4 (PDE4) inhibitor with antifibrotic properties, which means it helps reduce lung scarring by targeting a specific enzyme pathway. This mechanism is different from other treatments like nintedanib and pirfenidone, which also aim to reduce scarring but through different biological pathways. ^{1 3 5 7 10}

Research Team

Eligibility Criteria

This trial is for people with idiopathic or progressive pulmonary fibrosis who completed a previous study (1305-0014 or 1305-0023) without dropping out early. They must consent to the study's rules and, if they can have children, agree to use effective birth control during the trial.

Inclusion Criteria

I finished treatment in trials 1305-0014 or 1305-0023 without stopping early, even if there were short breaks.

I have signed and dated the consent form according to guidelines before joining the trial.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take nerandomilast as tablets for up to 1 year and 10 months

22 months

Regular visits to doctors

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 1015550 (Other)

Trial Overview The trial tests long-term tolerance of BI 1015550 in patients with pulmonary fibrosis. It aims to see if this drug improves lung function and delays worsening symptoms, hospital visits, or death. Participants take BI 1015550 tablets alongside their usual treatments for up to one year and ten months.

Participant Groups

Group I: BI 1015550 treatment group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

In a trial involving 147 participants with idiopathic pulmonary fibrosis (IPF) across 22 countries, the medication BI 1015550 was found to effectively prevent the decline in lung function compared to a placebo.

While BI 1015550 did not lead to a higher rate of severe adverse events compared to placebo, it was associated with more cases of diarrhea, and 13 participants discontinued treatment due to medical issues, indicating the need for further studies to assess its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plain language summary: Clinical study of BI 1015550 as a potential treatment for idiopathic pulmonary fibrosis. Richeldi, L., Azuma, A., Cottin, V., et al.[2023]

The BI 101550 trial, a phase 2 randomized controlled trial, demonstrated positive results in improving lung function (measured by forced vital capacity) in patients with idiopathic pulmonary fibrosis (IPF) over 12 weeks, indicating its potential as an effective add-on therapy.

The RELIEF trial also showed positive outcomes for patients with progressive fibrosing interstitial lung disease (PFILD) over 48 weeks, suggesting that both trials contribute valuable insights into the evolving treatment landscape for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Add-on therapy for pulmonary fibrosis, a forthcoming era with implications for practice: the BI 101550 and RELIEF trials. Planas-Cerezales, L., Fabbri, L., Pearmain, L.[2023]

In a study of 92 patients with idiopathic pulmonary fibrosis (IPF) receiving pirfenidone, the drug showed an acceptable safety profile, with skin-related (25%) and gastrointestinal (17.5%) adverse events being the most common, leading to discontinuation in 22.5% of cases.

Despite some patients experiencing significant improvements in lung function, the overall decline in lung function (%FVC and %DLCO) was noted over 36 months, highlighting the need for further research through prospective observational registries to better understand pirfenidone's long-term efficacy in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece. Tzouvelekis, A., Karampitsakos, T., Ntolios, P., et al.[2022]

In a study of 261 patients with idiopathic pulmonary fibrosis (IPF), those treated with pirfenidone had a significantly lower discontinuation rate due to adverse events compared to those treated with nintedanib (37% vs. 76% within one year).

Despite similar overall survival rates and treatment continuity, the higher rate of discontinuation due to adverse events in the nintedanib group suggests that managing these side effects is crucial for maintaining long-term antifibrotic therapy in IPF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Discontinuation Profiles between Pirfenidone and Nintedanib in Patients with Idiopathic Pulmonary Fibrosis. Takehara, K., Koga, Y., Hachisu, Y., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Plain language summary: Clinical study of BI 1015550 as a potential treatment for idiopathic pulmonary fibrosis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Tissue and Bronchoalveolar Lavage Biomarkers in Idiopathic Pulmonary Fibrosis Patients on Pirfenidone. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Add-on therapy for pulmonary fibrosis, a forthcoming era with implications for practice: the BI 101550 and RELIEF trials. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Phase I studies of BI 1015550, a preferential phosphodiesterase 4B inhibitor, in healthy males and patients with idiopathic pulmonary fibrosis. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Differential Discontinuation Profiles between Pirfenidone and Nintedanib in Patients with Idiopathic Pulmonary Fibrosis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

No effect of pirfenidone treatment in fulminant bleomycin-induced pneumonitis. [2020]