BI 1839100 for Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+181 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Boehringer Ingelheim

Must be taking: Nintedanib, Pirfenidone, Immunomodulatory

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. 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 chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF. During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

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.

How is the drug BI 1839100 different from other treatments for pulmonary fibrosis?

BI 1839100 is unique because it targets specific growth factor receptors involved in the development of pulmonary fibrosis, potentially slowing disease progression by inhibiting pathways that lead to lung scarring. This approach is different from other treatments that may not specifically target these pathways.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Hospital Gulfport Gulfport, MS

CIC Mauricie Inc. Trois-Rivieres, Canada

Clinical Research Associates of Central PA DuBois, PA

Critical Care, Pulmonary and Sleep Associates Lakewood, CO

More Trial Locations

Who Is Running the Clinical Trial?

Boehringer Ingelheim Lead Sponsor

References

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

No effect of pirfenidone treatment in fulminant bleomycin-induced pneumonitis. [2020] Bleomycin-induced pneumonitis (BIP) is a serious and potentially fatal adverse effect of bleomycin. Currently, BIP is treated on an empirical basis with high dose steroid. Pirfenidone is a new antifibrotic drug, which has been proven beneficial in idiopathic pulmonary fibrosis and is able to inhibit or reverse BIP in animal models. Here, the first two cases of human BIP treated with pirfenidone in addition to steroid therapy are presented. Unfortunately, both patients died, which may be explained by the initiation of therapy at a late stage. Therefore, studies of early or prophylactic treatment with pirfenidone in relation to bleomycin-containing chemotherapy regimens are needed.

2. England pubmed.ncbi.nlm.nih.gov

Plain language summary: Clinical study of BI 1015550 as a potential treatment for idiopathic pulmonary fibrosis. [2023] Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This plain language summary describes the main findings from a trial in people with idiopathic pulmonary fibrosis (also called IPF) that was recently published in the New England Journal of Medicine. IPF is a rare disease, where the lungs become more and more scarred, with breathing and oxygen uptake becoming increasingly difficult. This trial looked at the medication BI 1015550 as a potential treatment for IPF. It compared BI 1015550 to placebo (a dummy drug that does not contain any active ingredients) to investigate the effectiveness of the drug in treating people with IPF. The study also looked at the additional medical issues (referred to as adverse events) reported during the study. Some participants took approved treatments to reduce scarring (nintedanib or pirfenidone), and some did not.

3. England pubmed.ncbi.nlm.nih.gov

Inhibition of PDGF, VEGF and FGF signalling attenuates fibrosis. [2023] BIBF 1000 is a small molecule inhibitor targeting the receptor kinases of platelet-derived growth factor (PDGF), basic fibroblast growth factor and vascular endothelial growth factor, which have known roles in the pathogenesis of pulmonary fibrosis. The anti-fibrotic potential of BIBF 1000 was determined in a rat model of bleomycin-induced lung fibrosis and in an ex vivo fibroblast differentiation assay. Rats exposed to a single intra-tracheal injection of bleomycin were treated with BIBF 1000 starting 10 days after bleomycin administration. To gauge for anti-fibrotic activity, collagen deposition and pro-fibrotic growth factor gene expression was analysed in isolated lungs. Furthermore, the activity of BIBF 1000 was compared with imatinib mesylate (combined PDGF receptor, c-kit and c-abl kinase inhibitor) and SB-431542 (transforming growth factor (TGF)-beta receptor I kinase inhibitor) in an ex vivo TGF-beta-driven fibroblast to myofibroblast differentiation assay, performed in primary human bronchial fibroblasts. Treatment of rats with BIBF 1000 resulted in the attenuation of fibrosis as assessed by the reduction of collagen deposition and the inhibition of pro-fibrotic gene expression. In the cellular assay both SB-431542 and BIBF 1000 showed dose-dependent inhibition of TGF-beta-induced differentiation, whereas imatinib mesylate was inactive. BIBF 1000, or related small molecules with a similar kinase inhibition profile, may represent a novel therapeutic approach for the treatment of idiopathic pulmonary fibrosis.

4. Italy pubmed.ncbi.nlm.nih.gov

Nintedanib (BIBF 1120) for IPF: a tomorrow therapy? [2021] Idiopathic pulmonary fibrosis is a rare, life threatening disease characterized by an anarchic fibrogenesis, limited survival and few therapeutic options. Its pathogenesis is complex and involves the interaction among various pathways driven by proinflammatory/profibrogenetic mediators such as platelet -derived growth factor, vascular endothelial growth factor or basic fibroblast growth factor. Given their prominent pathogenic roles in this disease such growth factor might be suitable therapeutic targets.In fact, the existing preclinical and clinical data demonstrated that their therapeutic inhibition results in a delayed progression of the pulmonary fibrosis and in the improvement of the disease outcome. BIBF 1120 is a potent triple blocker of the receptors of these growth factors which is currently evaluated as a potential therapy in the idiopathic pulmonary fibrosis. This review discusses the existing data supporting its potential use in this disease.

5. 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] BI 1015550 is a phosphodiesterase 4 (PDE4) inhibitor that has antifibrotic properties. Phase I and Ic studies were conducted to investigate the safety, tolerability and pharmacokinetics of BI 1015550 in healthy male subjects and patients with idiopathic pulmonary fibrosis (IPF).