Brensocatib for Bronchiectasis

(ASPEN Trial)

No longer recruiting at 633 trial locations

Overseen By Insmed Medical Information

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Insmed Incorporated

Must not be taking: Prohibited medications

Disqualifiers: COPD, Asthma, Cystic fibrosis, HIV, 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: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called brensocatib to determine if it can reduce lung flare-ups in people with bronchiectasis, a lung condition marked by chronic coughing, sputum production, and frequent lung infections. Participants will receive either 10 mg or 25 mg of brensocatib, or a placebo (a dummy treatment with no active medication), to compare the frequency of lung exacerbations over a year. It suits individuals with bronchiectasis not related to cystic fibrosis who have experienced at least two lung flare-ups requiring antibiotics in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that some medications or therapies are prohibited during the study. It's best to discuss your current medications with the study team to see if they are allowed.

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

Previous studies have shown that brensocatib is generally safe for people taking it. Research indicates that both the 10 mg and 25 mg doses of brensocatib helped reduce lung flare-ups in patients with bronchiectasis. These studies did not reveal any major safety concerns for most patients.

In another study, patients who took brensocatib once a day experienced fewer lung problems over a year. The safety profile of this treatment was similar to a placebo, suggesting it is well-tolerated. While some patients experienced mild side effects, these were not severe enough to discontinue treatment.

Overall, current data suggests that brensocatib is safe for people with bronchiectasis and is tolerated by most patients. ^{1 2 3 4 5}

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

Brensocatib is unique because it targets an enzyme called neutrophil serine protease, which is involved in the inflammatory process of bronchiectasis. Unlike other treatments that focus on relieving symptoms or managing infections, brensocatib aims to reduce inflammation at its source by inhibiting this enzyme. Researchers are excited about this approach because it could potentially address the underlying cause of the condition, leading to better long-term outcomes for patients. Additionally, brensocatib offers a convenient oral tablet form, making it easy to incorporate into daily routines.

What evidence suggests that brensocatib might be an effective treatment for bronchiectasis?

This trial will compare the effects of different doses of brensocatib with a placebo in managing bronchiectasis. Studies have shown that taking brensocatib once a day can reduce lung flare-ups in people with bronchiectasis. Specifically, research indicates that both the 10 mg and 25 mg doses of brensocatib, which participants in this trial may receive, led to fewer yearly lung flare-ups compared to those taking a placebo (a pill with no active medicine). Additionally, patients taking brensocatib experienced a longer time before their first flare-up. Overall, these findings suggest that brensocatib can help manage bronchiectasis by reducing lung-related issues. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with non-cystic fibrosis bronchiectasis, confirmed by CT scan, who've had at least one lung infection needing antibiotics in the past year. Participants must be able to consent and follow study procedures. Pregnant women or those of childbearing potential must use effective contraception.

Inclusion Criteria

I have a lung condition confirmed by a CT scan, not related to cystic fibrosis.

I have needed antibiotics for respiratory infections at least twice in the last year.

I am a teenager and have had at least one lung flare-up in the last year.

Exclusion Criteria

I have not received a live vaccine in the last 4 weeks.

Inability to follow the procedures of the study (eg, due to language problems or psychological disorders)

Participated in any other interventional clinical studies within 3 months before Screening Visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brensocatib or placebo once daily for 52 weeks to evaluate the effect on pulmonary exacerbations

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brensocatib
• Placebo

Trial Overview The trial tests brensocatib's effectiveness at two doses (10 mg and 25 mg) versus a placebo in reducing lung infections over a year. It aims to see if brensocatib can lower the frequency of these exacerbations compared to not taking the drug.

How Is the Trial Designed?

Group I: Brensocatib 25 mg Experimental Treatment 1 Intervention

Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.

Group II: Brensocatib 10 mg Experimental Treatment 1 Intervention

Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials

44

Recruited

7,600+

Citations

1. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2411664

Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in ... Among patients with bronchiectasis, once-daily treatment with brensocatib (10 mg or 25 mg) led to a lower annualized rate of pulmonary exacerbations than ...

2. icer.org icer.org/wp-content/uploads/2025/10/ICER_NCFB-Final-Report_For-Publication_103025.pdf

Brensocatib for Non-Cystic Fibrosis Bronchiectasis clinical trial effectiveness using the results of brensocatib 10 mg compared with placebo from the. ASPEN trial. Analysis 5 (Subgroup ...

3. investor.insmed.com investor.insmed.com/2025-05-21-Brensocatib-Shows-Consistent-Efficacy-and-Safety-Across-Three-Prespecified-Subgroups-in-New-Data-from-Landmark-ASPEN-Study

Brensocatib Shows Consistent Efficacy and Safety Across ... Three prespecified subgroup analyses from ASPEN showed brensocatib reduced pulmonary exacerbations, prolonged time to first exacerbation, and reduced lung ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04594369

NCT04594369 | A Study to Assess the Efficacy, Safety, and ... The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations ...

5. icer.org icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-evidence-report-on-treatment-for-non-cystic-fibrosis-bronchiectasis/

Institute for Clinical and Economic Review Publishes ... According to current evidence, brensocatib improves overall health outcomes within the trial population, however some important uncertainties ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40753522/

A Phase IIa, Single-Blind, Placebo-Controlled, Parallel ... This study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of brensocatib in adults with cystic ...

7. icer.org icer.org/wp-content/uploads/2025/07/ICER_NCFB_Draft-Report_For-Publication_072325.pdf

Brensocatib for Non-Cystic Fibrosis Bronchiectasis Model results therefore represent average findings across patients and should not be presumed to represent the clinical or cost outcomes for any.