BI 1291583 for Bronchiectasis

No longer recruiting at 157 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Antifungals, Antituberculars, Antivirals, others

Disqualifiers: Cystic fibrosis, Liver disease, HIV, others

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

Compensation: Varies

Number of Visits: 10

Duration: 24-52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new medicine, BI 1291583, can help people with bronchiectasis, a lung condition that causes persistent cough and sputum production. Participants divide into four groups; three receive different doses of the medicine, while one group receives a placebo (a pill that looks like the medicine but has no active ingredients). The researchers aim to determine if the medicine reduces the frequency of flare-ups (sudden worsening of symptoms). This trial suits adults who regularly produce sputum and have experienced flare-ups requiring antibiotics in the past year. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that patients who must continue taking restricted medications or any drug likely to interfere with the trial may be excluded. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BI 1291583, a new treatment for bronchiectasis, looks promising in safety studies. Earlier research found that this medicine had a good balance between benefits and risks for patients, with no major safety concerns at the doses tested. Researchers are studying BI 1291583 to assess its tolerability and safety. These studies suggest that the treatment is well-tolerated. Participants in previous trials did not report significant side effects, indicating it might be safe for use in humans. ^{1 2 3 4 5}

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

Researchers are excited about BI 1291583 for bronchiectasis because it offers a new approach to managing this chronic lung condition. Unlike existing treatments that primarily focus on managing symptoms and infections, BI 1291583 works by potentially targeting the underlying inflammation that contributes to bronchiectasis. The drug is being tested in varying doses, which might help identify the optimal dosage for reducing inflammation with the best balance of efficacy and safety. This new mechanism of action could lead to more effective management of the condition and improve the quality of life for patients who currently have limited treatment options.

What evidence suggests that this trial's treatments could be effective for bronchiectasis?

Research has shown that BI 1291583 might help reduce flare-ups in people with bronchiectasis. In earlier studies, this medication lowered the chances of experiencing a sudden worsening of symptoms, known as an exacerbation. BI 1291583 blocks an enzyme possibly linked to inflammation. In this trial, participants will receive different doses of BI 1291583 or a placebo to assess its impact on flare-ups. Early results suggest that varying doses of this treatment can affect the timing of a flare-up. This offers hope for managing symptoms and possibly improving the quality of life for people with bronchiectasis. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-85 with bronchiectasis, who produce sputum and have had flare-ups requiring antibiotics can join this study. They must use effective contraception if of childbearing potential. Excluded are those with certain other diseases like Cystic Fibrosis or immune deficiencies, severe liver disease, recent infections, or uncontrolled medical conditions.

Inclusion Criteria

I will use contraception if my partner can become pregnant.

I am using highly effective birth control and one barrier method.

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

Exclusion Criteria

You have another serious health condition that could be made worse by taking part in the study.

You have certain medical conditions, such as cystic fibrosis, immune system disorders, skin conditions, or infections, that would prevent you from participating in the trial.

I have severe gum disease or teeth issues that could cause pain or need extraction.

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 1291583 or placebo for 6 months to 1 year

24-52 weeks

10 visits (in-person), 5 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 1291583
• Placebo

Trial Overview The trial is testing the effectiveness of BI 1291583 in different doses compared to a placebo for treating bronchiectasis. Participants will be randomly assigned to one of four groups and take tablets daily for 6 months to a year while their health and flare-up frequency are monitored.

How Is the Trial Designed?

Group I: BI 1291583: Medium dose group Experimental Treatment 1 Intervention

Group II: BI 1291583: Low dose group Experimental Treatment 1 Intervention

Group III: BI 1291583: High dose group Experimental Treatment 1 Intervention

Group IV: 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 double-blind, placebo-controlled study of 24 patients with bronchiectasis, inhaled fluticasone significantly reduced inflammatory markers in sputum, including leukocyte density and interleukin levels, indicating its efficacy in managing inflammation associated with the condition.

The treatment group experienced fewer exacerbations (1 episode) compared to the placebo group (3 episodes), and there were no significant changes in lung function or adverse reactions, suggesting that fluticasone is safe for use in bronchiectasis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled fluticasone reduces sputum inflammatory indices in severe bronchiectasis. Tsang, KW., Ho, PL., Lam, WK., et al.[2015]

Bronchiectasis (BE) is a growing global health issue characterized by airway dilation and persistent infections, leading to significant impacts on patients' quality of life, yet treatment guidelines are based on limited high-quality evidence.

Experts identified critical unmet needs in BE management, including the need for better pharmacological treatments to clear airways and reduce inflammation, improved methods for classifying patients, and the establishment of clinical endpoints for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. Flume, PA., Basavaraj, A., Garcia, B., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39255990/

AIRLEAF, a phase II randomised, double-blind, placebo ... Conclusion: Treatment with BI 1291583 resulted in a reduction in the risk of experiencing an exacerbation in adults with bronchiectasis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05238675

NCT05238675 | A Study to Test Whether Different Doses of ... The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37465817/

A Phase 2 randomised study to establish efficacy, safety ... The primary efficacy objective is to evaluate the dose-response relationship for the three oral doses of BI 1291583 versus placebo on time to ...

4. publications.ersnet.org publications.ersnet.org/content/erjor/9/3/00633-2022

A Phase 2 randomised study to establish efficacy, safety and ... This study aims to evaluate the efficacy, safety and optimal dosing of the novel CatC inhibitor BI 1291583 in adults with bronchiectasis. If efficacy and safety ...

5. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/lung-diseases/phase-iii-airtivity-trial

Phase III AIRTIVITY trial Verducatib (BI 1291583) is a novel dipeptyl peptidase 1 (DPP1) / cathepsin C (CatC) inhibitor with the potential to improve symptoms and quality of life for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569199325007775

WS19.05 A Phase II trial (CLAIRAFLY) to evaluate the ... The CatC inhibitor BI 1291583 has been shown to reduce pulmonary exacerbations (PEx) in people with non–CF BE (NCFBE) (Ph 2 study AIRLEAF®). We present the ...

7. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.16249

A randomized phase I study of the safety and ... The results show that BI 1291583 has an appropriate benefit–risk ratio for Japanese patients, with no safety or exposure concerns at the doses studied.