Trial · NCT04594369

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

NCT04594369, Phase 3, Completed, Insmed Incorporated; results first posted 2025-12-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis. Trials, record NCT04594369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04594369

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
NCT number: NCT04594369
Status: Completed
Phases: Phase 3
Enrollment: 1,767 participants, actual
Lead sponsor: Insmed Incorporated
Conditions: Non-Cystic Fibrosis Bronchiectasis
Interventions: Brensocatib 10 mg, Brensocatib 25 mg, Placebo
First posted: 2020-10-20
Last updated: 2025-12-16
Other registries' IDs: eudract:2020-003688-25
Results first posted: 2025-12-16

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Annualized Rate of Pulmonary Exacerbations (PEs)	Up to Week 52	PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Secondary	Time to First PE	Up to Week 52	PE was defined as having 3 or more of following symptoms for at least 48 hours resulting in physician's decision to prescribe antibiotics:1.Increased cough2.Increased sputum volume or change in sputum consistency3.Increased sputum purulence4.Increased breathlessness \&/or decreased exercise tolerance5.Fatigue \&/or malaise6.Hemoptysis.Severe PE were those requiring IV antibacterial drug treatment \&/or hospitalization. Minimum of 14 days must have occurred between one exacerbation onset and next. Any exacerbation that occurred within 14 days of prior exacerbation was not considered a new exacerbation. Time to first PE was calculated from randomization date to onset date of the first exacerbation. Participants who did not have exacerbation at end of 52-week treatment period were considered as censored at date of Week 52 in Cox proportional hazard model. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil protocol definition.
Secondary	Responder Status for Exacerbation-Free Over the 52-Week Treatment Period	Up to Week 52	Responder status was based on percentage of participants who were exacerbation free over 52-weeks of treatment period. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee of pulmonary physicians adjudicated reported PE events to see if they fulfill protocol definition. For discontinuation prior to Week 52 without having experienced a confirmed PE, responder status was imputed by multiple imputation.
Secondary	Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline, Week 52	FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by spirometer. Postbronchodilator FEV1 tests included spirometry tests performed referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol, terbutaline or ipratropium). A positive change from baseline indicates an improvement in lung function. Baseline was the most recent non-missing assessment determined as best effort prior to the first dose of the investigational product.
Secondary	Annualized Rate of Severe PEs	Up to Week 52	Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe PE was defined as those requiring IV antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjucated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Secondary	Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants	Baseline, Week 52	The QOL-B is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with non-cystic fibrosis bronchiectasis (NCFBE). It contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. Baseline refers to most recent assessment on or before study Day 1.
Secondary	Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)	Up to Week 56	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occurred on or after the date of first dose of study drugs and within 28 days after the end of treatment.
Secondary	Plasma Concentration of Brensocatib in Adults (Main Study)	2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52
Secondary	Plasma Concentration of Brensocatib in Adults (PK Substudy)	0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52
Secondary	Plasma Concentration of Brensocatib in Adolescents (Main Study)	0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annualized Rate of Pulmonary Exacerbations (PEs)	Up to Week 52	The ITT analysis set included all participants who were randomized.	exacerbation per participant-year	NUMBER
SECONDARY	Time to First PE	Up to Week 52	The ITT analysis set included all participants who were randomized.	weeks	MEDIAN
SECONDARY	Responder Status for Exacerbation-Free Over the 52-Week Treatment Period	Up to Week 52	The ITT analysis set included all participants who were randomized.	percentage of participants	NUMBER
SECONDARY	Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline, Week 52	The ITT analysis set included all participants who were randomized. 'Overall number of participants analyzed' indicates the number of participants with data available for analyses.	liter (L)	LEAST_SQUARES_MEAN
SECONDARY	Annualized Rate of Severe PEs	Up to Week 52	The ITT analysis set included all participants who were randomized.	exacerbation per participant-year	NUMBER
SECONDARY	Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants	Baseline, Week 52	The ITT analysis set included all participants who were randomised. Overall number of participants analyzed indicates the number of participants with data available for analyses.	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)	Up to Week 56	The Safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plasma Concentration of Brensocatib in Adults (Main Study)	2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52	The Pharmacokinetics (PK) concentration analysis set included adult participants who consented to participate in the main study in adult's cohort, received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adult participants with data available for analysis at specified time point.	nanograms per milliliter (ng/ml)	GEOMETRIC_MEAN
SECONDARY	Plasma Concentration of Brensocatib in Adults (PK Substudy)	0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52	The PK concentration analysis set included adult participants who consented to participate in the PK substudy and received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adult participants with data available for analysis at specified time point.	ng/ml	GEOMETRIC_MEAN
SECONDARY	Plasma Concentration of Brensocatib in Adolescents (Main Study)	0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52	The PK concentration analysis set included adolescent participants who consented to participate in the main study and received at least 1 dose of brensocatib, and had at least 1 postdose plasma concentration of brensocatib. 'Overall number of participants analyzed' indicates the number of participants with data available for analysis. 'Number analyzed' signifies number of adolescent participants with data available for analysis at specified time point.	ng/ml	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group91

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Annualized Rate of Pulmonary Exacerbations (PEs)	Brensocatib 10 mg	1.015	95% Confidence Interval 0.910 to 1.132	exacerbation per participant-year
Annualized Rate of Pulmonary Exacerbations (PEs)	Brensocatib 25 mg	1.036	95% Confidence Interval 0.927 to 1.157	exacerbation per participant-year
Annualized Rate of Pulmonary Exacerbations (PEs)	Placebo	1.286	95% Confidence Interval 1.158 to 1.428	exacerbation per participant-year
Time to First PE	Brensocatib 10 mg	49.000	95% Confidence Interval 40.000 to NA	weeks
Time to First PE	Brensocatib 25 mg	50.714	95% Confidence Interval 37.571 to NA	weeks
Time to First PE	Placebo	36.714	95% Confidence Interval 31.143 to 41.429	weeks
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period	Brensocatib 10 mg	48.5		percentage of participants
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period	Brensocatib 25 mg	48.5		percentage of participants
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period	Placebo	40.3		percentage of participants
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Brensocatib 10 mg	-0.050	Standard Error 0.0093	liter (L)

1 to 10 of 91Source ClinicalTrials.gov

See all 91 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Brensocatib 10 Milligrams (mg)	583
Overall Study	STARTED	Brensocatib 25 mg	575
Overall Study	STARTED	Placebo	563
Overall Study	COMPLETED	Brensocatib 10 Milligrams (mg)	458
Overall Study	COMPLETED	Brensocatib 25 mg	466
Overall Study	COMPLETED	Placebo	457
Overall Study	NOT COMPLETED	Brensocatib 10 Milligrams (mg)	125
Overall Study	NOT COMPLETED	Brensocatib 25 mg	109
Overall Study	NOT COMPLETED	Placebo	106

Source ClinicalTrials.gov

Adverse events522

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	COVID-19	Infections and infestations	Brensocatib 10 mg	89	582
other	COVID-19	Infections and infestations	Brensocatib 25 mg	113	574
other	COVID-19	Infections and infestations	Placebo	83	563
other	Nasopharyngitis	Infections and infestations	Brensocatib 10 mg	45	582
other	Nasopharyngitis	Infections and infestations	Brensocatib 25 mg	36	574
other	Nasopharyngitis	Infections and infestations	Placebo	43	563
other	Urinary tract infection	Infections and infestations	Brensocatib 10 mg	27	582
other	Urinary tract infection	Infections and infestations	Brensocatib 25 mg	30	574
other	Urinary tract infection	Infections and infestations	Placebo	33	563
other	Back pain	Musculoskeletal and connective tissue disorders	Brensocatib 10 mg	13	582

1 to 10 of 522Source ClinicalTrials.gov

See all 522 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brensocatib 10 mg	2	582
Total, all-cause mortality	Brensocatib 25 mg	4	574
Total, all-cause mortality	Placebo	8	563
Total, other adverse events	Brensocatib 10 mg	197	582
Total, other adverse events	Brensocatib 25 mg	213	574
Total, other adverse events	Placebo	203	563
Total, serious adverse events	Brensocatib 10 mg	101	582
Total, serious adverse events	Brensocatib 25 mg	97	574
Total, serious adverse events	Placebo	108	563

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35976570	DERIVED	PubMed
39040578	DERIVED	PubMed
40267423	DERIVED	PubMed
41519018	DERIVED	PubMed
42461571	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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