BI 1839100 for Pulmonary Fibrosis

No longer recruiting at 233 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Nintedanib, Pirfenidone, Immunomodulatory

Disqualifiers: Acute exacerbation, Reversible airflow, Chronic infection, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively the new treatment, BI 1839100, reduces coughing in individuals with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Participants with IPF are divided into groups to receive either varying doses of the treatment or a placebo, which resembles the treatment but contains no active medicine. The trial assesses coughing and lung function to evaluate the treatment's effectiveness. This study suits those who have experienced a chronic cough for more than eight weeks due to IPF or PPF and have not found relief with other treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are taking nintedanib or pirfenidone, you can continue these medications as long as you have been on a stable dose for at least 12 weeks before starting the trial and plan to stay on them throughout the trial. If you are not on these medications, you should not start or restart them during the trial. For PPF, if you are on immunomodulatory therapy like tacrolimus, mycophenolate mofetil, or azathioprine, you can continue if the dose has been stable for 12 weeks before the trial.

Is there any evidence suggesting that BI 1839100 is likely to be safe for humans?

Research shows that BI 1839100 has undergone testing for safety and tolerability. In studies, participants taking up to 300 mg of BI 1839100 did not experience more side effects than those taking a placebo, a harmless pill. This suggests that the treatment is generally well-tolerated. The drug's movement through the body remained consistent across different doses. These results are encouraging, but more information is needed before certainty can be achieved. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary fibrosis?

Unlike the standard treatments for pulmonary fibrosis, which often include medications like pirfenidone and nintedanib that aim to slow disease progression, BI 1839100 works differently by potentially targeting new pathways involved in the disease. Researchers are excited about BI 1839100 because of its novel approach, offering low, medium, and high-dose options to explore optimal efficacy and safety. This treatment could provide a fresh avenue for patients, especially those who may not respond well to existing therapies.

What evidence suggests that BI 1839100 might be an effective treatment for pulmonary fibrosis?

Research has shown that BI 1839100 might help reduce coughing in people with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Early studies found it can lower the frequency of coughing in these conditions. In this trial, participants will receive different doses of BI 1839100 or a placebo to test its effectiveness in reducing cough frequency and severity. Although still under study, early results appear promising for those with chronic coughing due to IPF and PPF. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 40+ with idiopathic pulmonary fibrosis (IPF) or those aged 18+ with progressive pulmonary fibrosis (PPF), who have a chronic cough, can join this study. They must not be on certain lung fibrosis treatments for at least 12 weeks before the trial and should not plan to start them during the trial. Their lungs must function at a minimum level.

Inclusion Criteria

I have been diagnosed with idiopathic pulmonary fibrosis.

I have a chronic cough for over 8 weeks due to IPF, not improved by treatments.

I am at least 40 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive BI 1839100 or placebo for 12 weeks. Coughing is measured monthly, and questionnaires and breathing tests are conducted.

12 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1839100

Trial Overview The study tests if BI 1839100 reduces cough in IPF or PPF patients compared to a placebo. Participants are randomly assigned to receive different doses of BI 1839100 or placebo for three months, with their coughing measured using a portable device and through questionnaires.

How Is the Trial Designed?

Group I: Phase IIb, PPF cohort: BI 1839100 high dose Experimental Treatment 1 Intervention

Group II: Phase IIa/IIb, IPF cohort: BI 1839100 medium dose Experimental Treatment 1 Intervention

Group III: Phase IIa/IIb, IPF cohort: BI 1839100 low dose Experimental Treatment 1 Intervention

Group IV: Phase IIa/IIb, IPF cohort: BI 1839100 high dose Experimental Treatment 1 Intervention

Group V: Phase IIb, PPF cohort: Placebo Placebo Group 1 Intervention

Group VI: Phase IIa/IIb, IPF cohort: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

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]

BIBF 1000 effectively reduced lung fibrosis in a rat model by decreasing collagen deposition and inhibiting pro-fibrotic gene expression, indicating its potential as an anti-fibrotic treatment.

In ex vivo assays, BIBF 1000 demonstrated dose-dependent inhibition of fibroblast differentiation driven by TGF-beta, outperforming imatinib mesylate, suggesting it could be a promising new therapy for idiopathic pulmonary fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of PDGF, VEGF and FGF signalling attenuates fibrosis. Chaudhary, NI., Roth, GJ., Hilberg, F., 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]

Idiopathic pulmonary fibrosis is a serious disease with limited treatment options, and it involves complex interactions among various proinflammatory and profibrogenetic growth factors.

BIBF 1120, a potent triple blocker of these growth factor receptors, has shown promise in preclinical and clinical studies by delaying disease progression and improving outcomes for patients with idiopathic pulmonary fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib (BIBF 1120) for IPF: a tomorrow therapy? Antoniu, SA.[2021]

Pirfenidone, an antifibrotic drug, was used in combination with steroids to treat two human cases of bleomycin-induced pneumonitis (BIP), but unfortunately, both patients died, suggesting that the treatment may have been initiated too late.

The findings highlight the need for further research into early or preventive use of pirfenidone during bleomycin-containing chemotherapy to potentially improve outcomes for patients at risk of developing BIP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No effect of pirfenidone treatment in fulminant bleomycin-induced pneumonitis. Bendstrup, E., Hyldgaard, C., Agerbæk, M., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06360094

A Study to Test Whether BI 1839100 Improves Cough in ... The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF. Participants who have IPF are put into 4 groups by ...

2. clinicaltrial.be clinicaltrial.be/fr/details/447458?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Study to Test Whether BI 1839100 Improves Cough in ... ... Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis With Clinically Meaningful Cough ... BI 1839100 helps reduce coughing in people with IPF or PPF.

3. pulmonaryfibrosis.org pulmonaryfibrosis.org/patients-caregivers/education-resources/clinical-trials-blog/clinical-trials/2025/08/20/july-2025-clinical-trial-highlights

July 2025 clinical trial highlights ... BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis ... IPF trial shows positive results.

4. clinicaltrials.eu clinicaltrials.eu/inn/bi-1839100/

Bi 1839100 – Application in Therapy and Current ... These trials aim to assess the safety, tolerability, and effectiveness of BI 1839100 in healthy individuals and patients with idiopathic pulmonary fibrosis (IPF) ...

5. withpower.com withpower.com/trial/phase-2-pulmonary-fibrosis-6-2024-04f62

BI 1839100 for Pulmonary Fibrosis · Info for Participants 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06360094

NCT06360094 | A Study to Test Whether BI 1839100 ... The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF. Participants who have IPF are put into 4 groups by ...

7. pulmonaryfibrosis.org pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/clinical-trials-education-center/pipeline/drug/idiopathic-pulmonary-fibrosis/bi-1839100

BI 1839100 The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12292558/

Proof of Pharmacology, Safety, and ... This study aims to support the pharmacological rationale of BI 1839100 based on preclinical evidence and to test its safety, pharmacokinetic (PK) profile, and ...

9. sigma.larvol.com sigma.larvol.com/product.php?e1=1000901&tab=newstrac

BI 1839100 News No significant imbalance in occurrence of adverse events was detected between single doses of BI 1839100 up to 300?mg and placebo, and PK profiles were dose- ...