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Phase 3 Completed N=1,721 Randomized Double-blind Treatment

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

Non-Cystic Fibrosis Bronchiectasis
Source: ClinicalTrials.gov NCT04594369 ↗
Enrolled (actual)
1,721
Serious AEs
17.8%
Results posted
Dec 2025
Primary outcomePrimary: Annualized Rate of Pulmonary Exacerbations (PEs) — 1.015; 1.036; 1.286 exacerbation per participant-year — p==0.0019
◆ Published Evidence
Highly cited
136citations · ~136 / year
Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis.
The New England journal of medicine · 2025 · Open access · Likely link

Summary

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 (PEs) over the 52-week treatment period.

Linked Publications (4)

  • Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis.
    The New England journal of medicine · 2025 · 136 citations · Open access · Likely link
  • Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics.
    ERJ open research · 2024 · 32 citations · Open access · Likely link
  • Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis.
    Clinical pharmacokinetics · 2022 · 24 citations · Open access · Likely link
  • Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial.
    Respiratory investigation · 2026 · 0 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Annualized Rate of Pulmonary Exacerbations (PEs)
1.015; 1.036; 1.286 =0.0019 sig
SECONDARY
Time to First PE
49.000; 50.714; 36.714 =0.01 sig
SECONDARY
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period
48.5; 48.5; 40.3 =0.0059 sig
SECONDARY
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
-0.050; -0.024; -0.062 =0.3841
SECONDARY
Annualized Rate of Severe PEs
0.137; 0.137; 0.185 =0.1277
SECONDARY
Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
6.841; 8.575; 4.809 =0.0594
SECONDARY
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
452; 440; 448
SECONDARY
Plasma Concentration of Brensocatib in Adults (Main Study)
40.52; 134.9; 52.60; 157.4; 100.5; 293.6
SECONDARY
Plasma Concentration of Brensocatib in Adults (PK Substudy)
34.51; 85.13; 44.52; 120.0; 38.13; 108.5
SECONDARY
Plasma Concentration of Brensocatib in Adolescents (Main Study)
63.20; 109.3; 68.33; 202.5; 56.07; 196.1

Eligibility Criteria

Inclusion Criteria

  • Provide their signed study informed consent to participate.

a. Adolescent participants must have signed study assent form to participate, and the adolescent's parent or legal guardian must have provided signed informed consent for the adolescent to participate.

  • Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan.
  • At least 2 PEs defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.

a. Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.

  • Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (ie, methods that can achieve a failure rate <1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
  • Male participants with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
  • Male participants with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.

Exclusion Criteria

  • A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
  • Bronchiectasis due to cystic fibrosis.
  • Current smokers as defined per Centers for Disease Control (CDC).
  • Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
  • Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
  • Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
  • Receiving medications or therapy that are prohibited as concomitant medications.
  • Previously participated in a clinical trial for brensocatib.
  • Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib.
  • Suffering an exacerbation 4 weeks before Screening or during the Screening period.
  • Adult participants only: Have compliance issues with completion of electronic diary entries during the Screening Period and in the opinion of the Investigator, compliance is unlikely to improve during the study.
  • Participated in any other interventional clinical studies within 3 months before Screening Visit.
  • History of alcohol or drug abuse within 6 months prior to the Screening Visit.
  • Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
  • Known history of hypersensitivity to brensocatib or any of its excipients.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04594369) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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