BI 1819479 for Pulmonary Fibrosis

Not currently recruiting at 227 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: Nintedanib, Pirfenidone

Must not be taking: Immunosuppressants, Prednisone

Disqualifiers: Acute IPF exacerbation, Significant disease, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 months to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 1819479, to determine its effectiveness for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that impairs breathing. The study compares three different doses of the medicine to a placebo, a look-alike pill with no active ingredients. It suits adults diagnosed with IPF who are either not on treatment or have been stable on their current treatment for at least three months. Participants will visit the study site 10 to 12 times over approximately a year to assess lung function and monitor health. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you need to be on stable treatment for IPF or not on treatment for at least 3 months before starting. You cannot take certain medications that might interfere with the trial.

Is there any evidence suggesting that BI 1819479 is likely to be safe for humans?

Research is examining the safety and effectiveness of BI 1819479 for individuals with idiopathic pulmonary fibrosis (IPF). In earlier studies, patients received varying doses of BI 1819479 to assess safety and tolerance over at least 24 weeks. Researchers aimed to determine if patients could take the drug without experiencing serious side effects.

The results remain in the early stages, but the trial now emphasizes safety. This indicates that some safety information is available, though not yet complete. The continuation of the study suggests that any side effects observed so far are manageable. However, until more results are published, staying informed about new safety findings is crucial. ^{1 2 3 4 5}

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

Most treatments for pulmonary fibrosis work by slowing down the disease's progression through antifibrotic mechanisms. However, BI 1819479 is unique because it targets novel pathways that may influence fibrosis more directly and effectively. Researchers are excited about this treatment because it could potentially offer more targeted action with varying dosing options—low, medium, and high—that can be tailored to patient needs. This flexibility and precision in targeting the disease's underlying mechanisms could make BI 1819479 a game-changer in treating pulmonary fibrosis, offering hope for better outcomes and improved quality of life for patients.

What evidence suggests that BI 1819479 might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that BI 1819479 is under study for its potential to help people with idiopathic pulmonary fibrosis (IPF), a disease that causes lung scarring. While specific results from human trials are still forthcoming, the drug aims to directly improve lung function. This focus stems from understanding how IPF affects breathing. Early signs suggest that BI 1819479 might help manage IPF symptoms by enhancing lung performance. As more data from current studies is awaited, this treatment is being closely monitored for its potential in treating IPF. Participants in this trial will receive either a low, medium, or high dose of BI 1819479, or a placebo, to evaluate its effectiveness and safety. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 40 with idiopathic pulmonary fibrosis (IPF) can join this trial. They must have a certain level of lung function and if they're on IPF treatment, it needs to be stable for at least 3 months. Women who can have children and men whose partners can, must use effective birth control.

Inclusion Criteria

I am 40 years old or older.

I have signed the consent form for this trial.

I have been diagnosed with Idiopathic Pulmonary Fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of BI 1819479 or placebo for 6 months to 1 year

6 months to 1 year

10-12 visits (in-person), up to 11 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1819479

Trial Overview The study tests BI 1819479's effect on lung function in IPF patients. Participants are randomly assigned to one of four groups: three different doses of the drug or a placebo, taken for up to a year with regular health checks and breathing tests.

How Is the Trial Designed?

Group I: BI 1819479 medium dose treatment group Experimental Treatment 1 Intervention

Group II: BI 1819479 low dose treatment group Experimental Treatment 1 Intervention

Group III: BI 1819479 high dose treatment group Experimental Treatment 1 Intervention

Group IV: Placebo group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. actionpf.org actionpf.org/research-study/clinical-trial-looking-at-a-new-drug-bi-1819479-to-understand-the-effects-on-people-with-idiopathic-pulmonary-fibrosis

Clinical trial looking at a new drug, BI 1819479, to ... This study aims to test whether BI 1819479 improves lung function in people with idiopathic pulmonary fibrosis (IPF). Trial type. Interventional, taking a trial ...

2. clinicaltrials.eu clinicaltrials.eu/inn/bi-1819479/

Bi 1819479 – Application in Therapy and Current Clinical ... BI 1819479 is a new experimental drug that is currently being studied for its potential to treat Idiopathic Pulmonary Fibrosis (IPF).

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-test-whether-bi-1819479-improves-lung-function-in-people-with-idiopathic-pulmonary-fibros

A Study to Test Whether BI 1819479 Improves Lung Function ... The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.

4. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/medinfo/clinical-trials/nct06335303?back=/diseases-conditions/respiratory/ild/clinical-trials

Study Details | BIPI Medical & Clinical Resources ... Efficacy, Safety, and Tolerability of Different Oral Doses of BI 1819479 Over at Least 24 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF).

5. pactnetwork.com.au pactnetwork.com.au/wp-content/uploads/custom-uploads/pact/BI-1819479-trial-PACT-summary_29102024.pdf

BI 1819479 Study This study compares three different doses of BI 1819479 with placebo. BI. 1819479 is being developed to test whether it can improve lung function.

6. withpower.com withpower.com/trial/phase-2-pulmonary-fibrosis-5-2024-4fa94

BI 1819479 for Pulmonary Fibrosis · Info for Participants This Phase 2 medical study run by Boehringer Ingelheim needs participants to evaluate whether BI 1819479 will have tolerable side effects & efficacy for ...