Trial Outcomes & Findings for Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis (NCT NCT03218917)
NCT ID: NCT03218917
Last Updated: 2023-03-27
Results Overview
Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. 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 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation. The analysis was performed using the stratified log rank test and using Kaplan Meier (KM) curves.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
Baseline (Day 1) to Week 24
Results posted on
2023-03-27
Participant Flow
Participants took part in the trial at 116 sites in 14 countries from 31 October 2017 to 12 December 2019.
416 participants were screened with 160 participants resulting in a screen failure. A total of 256 participants were randomized.
Participant milestones
| Measure |
Brensocatib 10 mg
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
87
|
87
|
|
Overall Study
Received Study Treatment (Safety Population)
|
81
|
89
|
85
|
|
Overall Study
Participants Did Not Receive Drug
|
0
|
0
|
1
|
|
Overall Study
Pharmacodynamic (PD) Population
|
80
|
89
|
84
|
|
Overall Study
COMPLETED
|
76
|
75
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
13
|
Reasons for withdrawal
| Measure |
Brensocatib 10 mg
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
2
|
|
Overall Study
Subject withdrew consent
|
2
|
4
|
10
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Reason Missing
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
0
|
1
|
0
|
Baseline Characteristics
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Baseline characteristics by cohort
| Measure |
Brensocatib 10 mg
n=82 Participants
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=87 Participants
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=87 Participants
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 12.67 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 12.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian (White)
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · African American/Black of African origin
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants who were randomized. Overall number of participants analyzed are number of participants with at least one exacerbation over 24-week treatment period.
Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. 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 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation. The analysis was performed using the stratified log rank test and using Kaplan Meier (KM) curves.
Outcome measures
| Measure |
Brensocatib 10 mg
n=26 Participants
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=29 Participants
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=42 Participants
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
|
NA days
The median, upper and lower limit of confidence interval (CI) was not estimated due to insufficient number of participants with exacerbations in Brensocatib 10 mg group.
|
NA days
The median, upper and lower limit of CI was not estimated due to insufficient number of participants with exacerbations in Brensocatib 25 mg group.
|
189.0 days
Interval 141.0 to
The upper limit of CI was not estimated due to insufficient number of participants with exacerbations in placebo.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants who were randomized. Overall number of participants analyzed are the number of participants with data available for analyses at the latest assessment visit over the 24-week treatment period.
The QOL-B is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning, and health-related (HR) QOL for participants with non-cystic fibrosis bronchiectasis (NCFBE). The QOL-B 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 and HR QoL. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. The analysis was based on mixed model for repeated measures (MMRM) approach.
Outcome measures
| Measure |
Brensocatib 10 mg
n=75 Participants
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=77 Participants
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=72 Participants
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period
|
3.8 score on a scale
Standard Error 0.78
|
5.9 score on a scale
Standard Error 0.76
|
5.7 score on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Screening (Days -42 to -1) to Week 24Population: ITT population included all participants who were randomized. Overall number of participants analyzed are the number of participants with data available for analyses over the 24-week treatment period.
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath. The percent predicted FEV1 was calculated by converting the spirometer reading to a percentage of what would be predicted as normal FEV1 based on a several personal factors (e.g. sex, age, etc.). Change from screening in percent predicted FEV1 to Week 24 was calculated as: percent predicted FEV1 value at Week 24 and percent predicted FEV1 value at screening. A positive percent change from screening indicates an improvement in lung function. The analysis was done using analysis of covariance (ANCOVA) with Pa colonization status and maintenance macrolide antibiotic use at Baseline as covariates.
Outcome measures
| Measure |
Brensocatib 10 mg
n=77 Participants
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=77 Participants
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=73 Participants
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period
|
-0.3 percent predicted FEV1
Standard Error 0.88
|
-0.3 percent predicted FEV1
Standard Error 0.85
|
-1.8 percent predicted FEV1
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: Pharmacodynamic population included participants who received at least 1 dose of the study drugs, have at least 1 pre-dose and 1 post-dose measurement for NE, or proteinase 3, or cathepsin G, or other biomarkers, and have no major protocol deviations that considered to impact on the analysis of the PD data.
The concentration of active NE in sputum, was measured by the difference between the pre-treatment concentration and on-treatment concentration. In bronchiectasis, activation of neutrophils in the airway leads to release of NE which leads to damaged airway walls, mucus hypersecretion, exacerbated inflammation, which in turn affects neutrophil and macrophage functions, increasing the risk of infection. Negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Brensocatib 10 mg
n=80 Participants
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=89 Participants
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=84 Participants
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum
|
-2.928 microgram/ milliliter (µg/mL)
Standard Error 0.351
|
-4.117 microgram/ milliliter (µg/mL)
Standard Error 0.322
|
-1.409 microgram/ milliliter (µg/mL)
Standard Error 0.313
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 24Population: ITT population included all participants who were randomized.
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 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation.
Outcome measures
| Measure |
Brensocatib 10 mg
n=82 Participants
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=87 Participants
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=87 Participants
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Pulmonary Exacerbation
|
26 Participants
|
29 Participants
|
42 Participants
|
Adverse Events
Brensocatib 10 mg
Serious events: 11 serious events
Other events: 47 other events
Deaths: 0 deaths
Brensocatib 25 mg
Serious events: 10 serious events
Other events: 43 other events
Deaths: 1 deaths
Placebo
Serious events: 19 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brensocatib 10 mg
n=81 participants at risk
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=89 participants at risk
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=85 participants at risk
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
6.2%
5/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
4.5%
4/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
10.6%
9/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
4.5%
4/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
3.5%
3/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Aspergilloma
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
2.4%
2/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carotid artery occlusion
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Alcohol abuse
|
1.2%
1/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Brensocatib 10 mg
n=81 participants at risk
Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
|
Brensocatib 25 mg
n=89 participants at risk
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
|
Placebo
n=85 participants at risk
Participants received the matching placebo QD before breakfast, for 24 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
5/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
3.4%
3/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
10.6%
9/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
2.5%
2/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
5.6%
5/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
0.00%
0/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
3.7%
3/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
7.9%
7/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
7.1%
6/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
6/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
4.5%
4/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
4.7%
4/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
6.2%
5/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
4.5%
4/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
7.1%
6/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
6/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
9.9%
8/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
13.5%
12/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
3.5%
3/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
15/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
13.5%
12/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
11.8%
10/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
11.1%
9/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
10.1%
9/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
7.1%
6/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
3/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
9.0%
8/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
2.4%
2/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.4%
6/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
2.2%
2/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.2%
1/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
2.5%
2/81 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
1.1%
1/89 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
5.9%
5/85 • Baseline to Week 28 (End of study visit)
Safety population included all participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60