BI 1291583 for Bronchiectasis

Recruiting at 396 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must not be taking: DPP1 inhibitors

Disqualifiers: Immunodeficiency, Aspergillosis, Tuberculosis, 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: 10

Duration: 76 weeks

1680 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is open to adults with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants complete a daily diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on stable oral or inhaled antibiotics or CFTR-MT for bronchiectasis, you may continue them as long as you meet the other criteria.

What data supports the effectiveness of the drug BI 1291583 for bronchiectasis?

The Phase 2 trial of BI 1291583 aims to show that inhibiting cathepsin C can reduce airway inflammation and improve symptoms in bronchiectasis by decreasing the activation of certain enzymes that cause damage. This approach is similar to the anti-inflammatory effects seen with brensocatib, another drug in development for bronchiectasis, which has shown a favorable benefit-risk profile in trials. ^{1 2 3 4 5}

Eligibility Criteria

Adults with bronchiectasis who produce sputum and have had at least 2 flare-ups or 1 flare-up with significant symptoms can join. They must consent to the study, use effective birth control if applicable, and have a CT-confirmed diagnosis. Those on certain chronic treatments need at least one recent exacerbation.

Inclusion Criteria

I can produce sputum for testing.

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

I am at least 18 years old or the legal age of consent in my country.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 1 tablet once a day for up to 1 year and 6 months. The study involves up to 10 site visits and about 13 phone calls. Participants complete a daily diary on a smartphone about their bronchiectasis symptoms.

76 weeks

10 visits (in-person), 13 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment. The study doctors regularly check participants' health and take note of any unwanted effects.

4 weeks

Treatment Details

Interventions

• BI 1291583

Trial Overview The AIRTIVITY® Study is testing BI 1291583 tablets against placebo in people with bronchiectasis. Participants are randomly assigned to take either the actual medicine or a look-alike without active ingredients daily for up to 18 months, tracking symptoms and flare-ups.

Participant Groups

Group I: Treatment arm Experimental Treatment 1 Intervention

Group II: Placebo arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

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]

References

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

A Phase 2 randomised study to establish efficacy, safety and dosing of a novel oral cathepsin C inhibitor, BI 1291583, in adults with bronchiectasis: Airleaf. [2023]

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

Benefit-risk assessment of brensocatib for treatment of non-cystic fibrosis bronchiectasis. [2023]

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

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in bronchiectasis: a propensity-matched study. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Inhaled Corticosteroid Therapy in Bronchiectasis is Associated with All-Cause Mortality: A Prospective Cohort Study. [2023]