BI 1015550 for Idiopathic Pulmonary Fibrosis

Recruiting at 411 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Disqualifiers: Pulmonary abnormalities, Infections, Malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 13

Duration: 52 weeks

1177 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking nintedanib or pirfenidone for your IPF, you can continue these medications during the study. The trial does not specify about other medications, so it's best to discuss with the study team.

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

The trial compared BI 1015550 to a placebo (a dummy drug) to see how well it worked for people with idiopathic pulmonary fibrosis (IPF), a condition where the lungs become scarred and breathing becomes difficult. Some participants also took other approved treatments like nintedanib or pirfenidone, which are known to help reduce lung scarring. ^{1 2 3 4 5}

Is BI 1015550 safe for humans?

In a clinical trial for idiopathic pulmonary fibrosis, BI 1015550 was compared to a placebo, and the study reported additional medical issues (adverse events) experienced by participants. This suggests that safety data was collected, but specific details about the safety profile of BI 1015550 are not provided in the available summaries. ^{1 6 7 8 9}

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

BI 1015550 is unique because it is a phosphodiesterase 4 (PDE4) inhibitor with antifibrotic properties, which means it helps reduce lung scarring in idiopathic pulmonary fibrosis (IPF). Unlike some existing treatments, it can be used as an add-on therapy for patients who are already on other antifibrotic medications like nintedanib or pirfenidone. ^{1 3 10 11 12}

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Idiopathic Pulmonary Fibrosis.

I have signed and understand the consent form for this trial.

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

Exclusion Criteria

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

I tested positive for COVID-19 and haven't fully recovered in the last 4 weeks.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 1015550 or placebo tablets twice a day for up to 52 weeks

52 weeks

10 visits (in-person) during the first year

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 78 weeks

Visits every 3 months

Treatment Details

Interventions

• BI 1015550
• Placebo

Trial Overview 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.

Participant Groups

Group I: BI 1015550 low dose Experimental Treatment 1 Intervention

Group II: BI 1015550 high dose Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 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]

A systematic review of six studies showed that pirfenidone, nintedanib, and pamrevlumab are all effective in slowing the decline of forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF), with pamrevlumab showing the highest effect size.

Only pirfenidone demonstrated a significant impact on all-cause mortality, suggesting it may offer additional benefits beyond just slowing FVC decline, while pamrevlumab is emerging as a promising candidate for future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis. Di Martino, E., Provenzani, A., Vitulo, P., et al.[2021]

In a study involving 13 patients with idiopathic pulmonary fibrosis (IPF), pirfenidone treatment did not significantly reduce the number of fibroblast foci, indicating that its anti-fibrotic effects may not be immediately observable in tissue samples after 6 months.

Despite the lack of significant changes in fibroblast foci and proliferation markers, the treatment was well-tolerated, and there was an increase in certain cytokines associated with angiogenesis and anti-inflammation, suggesting potential immunomodulatory effects of pirfenidone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue and Bronchoalveolar Lavage Biomarkers in Idiopathic Pulmonary Fibrosis Patients on Pirfenidone. Ronan, N., Bennett, DM., Khan, KA., et al.[2019]

The IFIGENIA trial demonstrated that N-acetylcysteine, when used alongside prednisone and azathioprine, significantly slowed the decline in lung function in patients with idiopathic pulmonary fibrosis over 12 months.

Pirfenidone is the first approved antifibrotic drug for idiopathic pulmonary fibrosis in the EU, showing efficacy in slowing lung function decline and reducing disease progression in over 1,100 patients across four clinical trials, though it may cause side effects like gastrointestinal discomfort and skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. Costabel, U., Bonella, F.[2021]

A comprehensive safety analysis of pirfenidone, involving 789 patients over a median exposure of 2.6 years, shows that it is generally safe and well tolerated for treating idiopathic pulmonary fibrosis (IPF).

The most common side effects were mild to moderate gastrointestinal and skin-related events, with serious liver enzyme elevations occurring in only 2.7% of patients, indicating a low risk of severe adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis. Valeyre, D., Albera, C., Bradford, WZ., et al.[2022]

In a study of 281 patients with idiopathic pulmonary fibrosis (IPF) treated with either pirfenidone or nintedanib, both drugs were found to be safe and well-tolerated, confirming their safety profiles in real-world settings.

Nintedanib was associated with a lower rate of permanent treatment discontinuation (8.3%) compared to pirfenidone (18.3%), and adverse events from nintedanib were generally easier to manage, indicating it may be a more favorable option for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. Levra, S., Guida, G., Sprio, AE., et al.[2022]

This study analyzed data from the Japanese Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) to investigate the incidence of interstitial lung disease (ILD) potentially caused by antifibrotic drugs nintedanib and pirfenidone, both of which are first-line treatments for idiopathic pulmonary fibrosis (IPF).

The findings indicated that both nintedanib and pirfenidone were associated with signals for causing ILD, emphasizing the need for careful monitoring of these drugs due to their limited effectiveness and potential to induce lung damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the potential complication of interstitial lung disease associated with antifibrotic drugs using data from databases reporting spontaneous adverse effects. Nawa, H., Hamano, H., Niimura, T., et al.[2023]

In a Phase I study involving 42 healthy male subjects, BI 1015550 showed a higher incidence of drug-related adverse events (AEs) compared to placebo, with 50% of subjects experiencing AEs after a single dose, primarily headaches.

In a Phase Ic study with 15 patients suffering from idiopathic pulmonary fibrosis (IPF), 90% of those treated with BI 1015550 reported drug-related AEs, mainly gastrointestinal issues, indicating that while the drug has an acceptable safety profile, further investigation in larger trials is warranted.

NCBI (Pubmed)

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. Maher, TM., Schlecker, C., Luedtke, D., et al.[2022]

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]

GDC-3280, an oral medication for idiopathic pulmonary fibrosis, was found to be generally well tolerated in a phase 1 trial with 80 participants, showing no serious adverse events and mostly mild side effects like headache and nausea.

The pharmacokinetics of GDC-3280 indicated that it is effectively absorbed, with significant increases in drug exposure when taken with food, supporting its future use in clinical trials for twice-daily administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects. Cheung, D., Fong, A., Ding, HT., et al.[2021]

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

Pirfenidone in real life: A retrospective observational multicentre study in Italian patients with idiopathic pulmonary fibrosis. [2020]

5. Japan pubmed.ncbi.nlm.nih.gov

Perioperative pirfenidone treatment for lung cancer patients with idiopathic pulmonary fibrosis. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Evaluation of the potential complication of interstitial lung disease associated with antifibrotic drugs using data from databases reporting spontaneous adverse effects. [2023]

10. 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]

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects. [2021]