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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003688-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brensocatib 10 milligrams (mg) | Experimental | Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks. |
|
| Brensocatib 25 mg | Experimental | Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brensocatib 10 mg | Drug | Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Pulmonary Exacerbations (PEs) | 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. | Up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First PE | 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. |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA013 | Birmingham | Alabama | 35233 | United States | ||
| USA080 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41519018 | Derived | Morimoto K, Chalmers JD, Burgel PR, Daley CL, De Soyza A, Mauger D, Metersky ML, Zhang X, Li S, Goto Y, Teper A, Fernandez C, Hasegawa N. Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial. Respir Investig. 2026 Mar;64(2):101357. doi: 10.1016/j.resinv.2025.101357. Epub 2026 Jan 9. | |
| 40267423 |
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A total of 2296 participants were screened, 1767 participants with non-cystic fibrosis bronchiectasis were enrolled in the study. Due to the war in Ukraine, 44 participants from Ukraine were discontinued and excluded from all analyses. There were 2 additional participants who were excluded from all analyses due to serious Good Clinical Practice (GCP) non-compliance. A total of 1721 participants were randomized and analyzed.
Participants took part in the study at 373 sites in 36 countries from 01 Dec 2020 to 28 Oct 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brensocatib 10 Milligrams (mg) | Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks. |
| FG001 | Brensocatib 25 mg | Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2024 | Nov 28, 2025 |
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| Brensocatib 25 mg | Drug | Oral tablet. |
|
|
| Placebo | Drug | Brensocatib-matching oral tablet. |
|
| Up to Week 52 |
| Responder Status for Exacerbation-Free Over the 52-Week Treatment Period | 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. | Up to Week 52 |
| Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1) | 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. | Baseline, Week 52 |
| Annualized Rate of Severe PEs | 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. | Up to Week 52 |
| Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants | 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. | Baseline, Week 52 |
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) | 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. | Up to Week 56 |
| 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 |
| 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 |
| 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 |
| Conway |
| Arkansas |
| 72032 |
| United States |
| USA044 | Little Rock | Arkansas | 72205 | United States |
| USA104 | Fresno | California | 93702 | United States |
| USA055 | Los Angeles | California | 90048 | United States |
| USA029 | Newport Beach | California | 92663 | United States |
| USA102 | Northridge | California | 91324 | United States |
| USA022 | Palm Springs | California | 92262 | United States |
| USA024 | Sacramento | California | 95817 | United States |
| USA035 | San Diego | California | 92120 | United States |
| USA078 | Santa Barbara | California | 93105 | United States |
| USA027 | Ventura | California | 93003 | United States |
| USA075 | Denver | Colorado | 80206 | United States |
| USA017 | Farmington | Connecticut | 06030 | United States |
| USA001 | Washington D.C. | District of Columbia | 20007 | United States |
| USA015 | Clearwater | Florida | 33765 | United States |
| USA076 | Gainesville | Florida | 32610 | United States |
| USA082 | Jacksonville | Florida | 32224 | United States |
| USA039 | Kissimmee | Florida | 34746 | United States |
| USA072 | Leesburg | Florida | 34748 | United States |
| USA037 | Miami | Florida | 33126 | United States |
| USA019 | Miami Lakes | Florida | 33014 | United States |
| USA049 | Naples | Florida | 34102 | United States |
| USA052 | Orlando | Florida | 32825 | United States |
| USA103 | Plantation | Florida | 33324 | United States |
| USA084 | Sarasota | Florida | 34239 | United States |
| USA089 | St. Petersburg | Florida | 33704 | United States |
| USA074 | St. Petersburg | Florida | 33707 | United States |
| USA120 | Tampa | Florida | 33606 | United States |
| USA012 | Atlanta | Georgia | 30342 | United States |
| USA053 | Augusta | Georgia | 30912 | United States |
| USA073 | Chicago | Illinois | 60611 | United States |
| USA061 | Maywood | Illinois | 60153 | United States |
| USA115 | Hammond | Indiana | 46324 | United States |
| USA063 | Iowa City | Iowa | 52242 | United States |
| USA031 | Kansas City | Kansas | 66160 | United States |
| USA020 | New Orleans | Louisiana | 70112 | United States |
| USA051 | New Orleans | Louisiana | 70112 | United States |
| USA003 | Baltimore | Maryland | 21224 | United States |
| USA079 | Boston | Massachusetts | 02114 | United States |
| USA064 | Springfield | Massachusetts | 01199 | United States |
| USA010 | Rochester | Minnesota | 55905 | United States |
| USA006 | Chesterfield | Missouri | 63017 | United States |
| USA059 | St Louis | Missouri | 63110 | United States |
| USA110 | Lincoln | Nebraska | 68510 | United States |
| USA065 | Toms River | New Jersey | 08755 | United States |
| USA066 | New Hyde Park | New York | 11042 | United States |
| USA021 | New York | New York | 10017 | United States |
| USA085 | New York | New York | 10032 | United States |
| USA033 | Gastonia | North Carolina | 28054 | United States |
| USA096 | Huntersville | North Carolina | 28078 | United States |
| USA026 | Winston-Salem | North Carolina | 27103 | United States |
| USA067 | Cincinnati | Ohio | 45267 | United States |
| USA093 | Cleveland | Ohio | 44195 | United States |
| USA023 | Portland | Oregon | 97239 | United States |
| USA038 | DuBois | Pennsylvania | 15801 | United States |
| USA046 | Philadelphia | Pennsylvania | 19104 | United States |
| USA005 | Charleston | South Carolina | 29425 | United States |
| USA036 | Rock Hill | South Carolina | 29732 | United States |
| USA041 | Franklin | Tennessee | 37067 | United States |
| USA109 | Nashville | Tennessee | 37232 | United States |
| USA097 | Dallas | Texas | 75246 | United States |
| USA050 | McKinney | Texas | 75069 | United States |
| USA011 | San Antonio | Texas | 78258 | United States |
| USA002 | Tyler | Texas | 75708 | United States |
| USA034 | Williamsburg | Virginia | 23188 | United States |
| USA088 | Vancouver | Washington | 98664 | United States |
| ARG027 | Bahía Blanca | Buenos Aires | 8000 | Argentina |
| ARG021 | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1121ABE | Argentina |
| ARG022 | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1122AAK | Argentina |
| ARG002 | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1414AIF | Argentina |
| ARG001 | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1425AZB | Argentina |
| ARG003 | Ciudad Autónoma de BuenosAires | Buenos Aires | C1425BEN | Argentina |
| ARG004 | Ciudad Autónoma de BuenosAires | Buenos Aires | C1426ABP | Argentina |
| ARG006 | La Plata | Buenos Aires | B1902COS | Argentina |
| ARG013 | Mar del Plata | Buenos Aires | B7600FYK | Argentina |
| ARG017 | Mar del Plata | Buenos Aires | CP 7600 | Argentina |
| ARG009 | Villa Vatteone | Buenos Aires | B1853AIK | Argentina |
| ARG012 | Buenos Aires | Ciudad Autónoma de BuenosAires | C10227AAP | Argentina |
| ARG018 | Buenos Aires | Ciudad Autónoma de BuenosAires | C1060 | Argentina |
| ARG026 | Recoleta | Ciudad Autónoma de BuenosAires | C1425EFD | Argentina |
| ARG023 | Río Cuarto | Córdoba Province | 5800 | Argentina |
| ARG014 | Vistalba | Mendoza Province | M5544 | Argentina |
| ARG010 | Rosario | Santa Fe Province | S2000DTC | Argentina |
| ARG015 | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| ARG025 | San Miguel de Tucumán | Tucumán Province | T4000IHE | Argentina |
| ARG005 | Córdoba | X5003DCE | Argentina |
| ARG007 | Mendoza | M5500CCG | Argentina |
| ARG011 | Rosario | S2000JKR | Argentina |
| ARG019 | Santa Fe | 3000 | Argentina |
| AUS013 | Kogarah | New South Wales | 2217 | Australia |
| AUS008 | New Lambton Heights | New South Wales | 2305 | Australia |
| AUS007 | Westmead | New South Wales | 2145 | Australia |
| AUS012 | Cairns North | Queensland | 4870 | Australia |
| AUS001 | Chermside | Queensland | 4032 | Australia |
| AUS010 | Greenslopes | Queensland | 4120 | Australia |
| AUS006 | South Brisbane | Queensland | 4101 | Australia |
| AUS019 | South Brisbane | Queensland | 4101 | Australia |
| AUS011 | Adelaide | South Australia | 5000 | Australia |
| AUS017 | Bedford Park | South Australia | 5042 | Australia |
| AUS022 | North Adelaide | South Australia | 5006 | Australia |
| AUS009 | Woodville South | South Australia | 5011 | Australia |
| AUS002 | Box Hill | Victoria | 3128 | Australia |
| AUS014 | Clayton | Victoria | 3168 | Australia |
| AUS018 | Murdoch | Western Australia | 6150 | Australia |
| AUS005 | Nedlands | Western Australia | 6009 | Australia |
| AUS003 | Concord | NSW 2139 | Australia |
| AUS015 | Spearwood | 6163 | Australia |
| AUT002 | Linz | 4021 | Austria |
| BEL002 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| BEL009 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| BEL004 | Roeselare | West-Vlaanderen | 8800 | Belgium |
| BEL001 | Leuven | 3000 | Belgium |
| BEL007 | Liège | 4000 | Belgium |
| BEL003 | Mechelen | 2800 | Belgium |
| BEL008 | Sint-Niklaas | 9100 | Belgium |
| BRA009 | Passo Fundo | Rio Grande do Sul | 99010-120 | Brazil |
| BRA005 | Porto Alegre | Rio Grande do Sul | 90035-074 | Brazil |
| BRA001 | Blumenau | Santa Catarina | 89030-240 | Brazil |
| BRA006 | Santo André | São Paulo | 09090-790 | Brazil |
| BRA003 | Botucatu | 18618-686 | Brazil |
| BRA004 | São Bernardo do Campo | 09715-090 | Brazil |
| BRA011 | São Paulo | 05403-000 | Brazil |
| BGR011 | Sofia | Sofia-Grad | 1336 | Bulgaria |
| BGR009 | Sofia | Sofia-Grad | 1510 | Bulgaria |
| BGR002 | Sofia | Sofia-Grad | 1680 | Bulgaria |
| BGR005 | Blagoevgrad | 2700 | Bulgaria |
| BGR006 | Gabrovo | 5300 | Bulgaria |
| BGR014 | Kozloduy | 3320 | Bulgaria |
| BGR015 | Lovech | 5500 | Bulgaria |
| BGR007 | Montana | 3400 | Bulgaria |
| BGR018 | Pazardzhik | 4400 | Bulgaria |
| BGR019 | Pleven | 5800 | Bulgaria |
| BGR004 | Plovdiv | 4023 | Bulgaria |
| BGR008 | Rousse | 7002 | Bulgaria |
| BGR017 | Sliven | 8800 | Bulgaria |
| BGR010 | Sofia | 1233 | Bulgaria |
| BGR012 | Veliko Tarnovo | 5000 | Bulgaria |
| BGR013 | Vidin | 3700 | Bulgaria |
| BGR016 | Vratsa | 3000 | Bulgaria |
| CAN004 | Toronto | Ontario | M5T 3A9 | Canada |
| CAN002 | Montreal | Quebec | H2X 0A9 | Canada |
| CHL007 | Valdivia | Los Ríos Region | 5110683 | Chile |
| CHL005 | Curicó | Maule Region | 3440000 | Chile |
| CHL010 | Talca | Maule Region | 3481349 | Chile |
| CHL001 | Providencia | Región-MetropolitanadeSantiago | 7500000 | Chile |
| CHL002 | Providencia | Región-MetropolitanadeSantiago | 7500000 | Chile |
| CHL008 | Providencia | Región-MetropolitanadeSantiago | 7500587 | Chile |
| CHL004 | Quillota | 2260000 | Chile |
| COL001 | Bogotá | Bogota D.C. | 111211 | Colombia |
| COL006 | Zipaquirá | Cundinamarca | 250252 | Colombia |
| COL005 | Floridablanca | Santander Department | 681004 | Colombia |
| COL003 | Cali | Valle del Cauca Department | 760026 | Colombia |
| COL002 | Bogota DC | 110131 | Colombia |
| COL004 | Santiago de Cali | 076001 | Colombia |
| DNK008 | Copenhagen O | Capital | 2100 | Denmark |
| DNK001 | Hvidovre | Capital | DK-2650 | Denmark |
| DNK005 | Odense C | Region Syddanmark | 5000 | Denmark |
| DNK006 | Vejle | Region Syddanmark | 7100 | Denmark |
| DNK003 | Aalborg | 9000 | Denmark |
| DNK007 | Aarhus | DK-8200 | Denmark |
| DNK004 | Hellerup | 2900 | Denmark |
| DNK002 | Roskilde | 4000 | Denmark |
| FRA002 | Strasbourg | Bas-Rhin | 67091 | France |
| FRA005 | Montpellier | Hérault | 34295 | France |
| FRA004 | Amiens | 80054 | France |
| FRA011 | Créteil | 94010 | France |
| FRA003 | Nantes | 44093 | France |
| FRA009 | Nice | 6002 | France |
| FRA010 | Paris | 75014 | France |
| FRA006 | Toulouse | 31400 | France |
| DEU009 | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| DEU025 | München | Bavaria | 80336 | Germany |
| DEU027 | Potsdam | Brandenburg | 14467 | Germany |
| DEU008 | Frankfurt am Main | Hesse | 60590 | Germany |
| DEU005 | Marburg | Hesse | 35037 | Germany |
| DEU031 | Hanover | Lower Saxony | 30625 | Germany |
| DEU013 | Essen | North Rhine-Westphalia | 45239 | Germany |
| DEU003 | Leipzig | Saxony | 04347 | Germany |
| DEU016 | Halle | Saxony-Anhalt | 06120 | Germany |
| DEU020 | Geesthacht | Schleswig-Holstein | 21502 | Germany |
| DEU002 | Berlin | 10717 | Germany |
| DEU019 | Berlin | 10961 | Germany |
| DEU006 | Berlin | 13125 | Germany |
| DEU011 | Berlin | 13353 | Germany |
| DEU014 | Dresden | 01307 | Germany |
| DEU021 | Frankfurt | 60389 | Germany |
| DEU015 | Hanover | 30625 | Germany |
| DEU023 | Mainz | 55128 | Germany |
| DEU029 | Münster | 48149 | Germany |
| GRC003 | Alexandroupoli | Evros | 681 00 | Greece |
| GRC007 | Heraklion | 71110 | Greece |
| GRC006 | Thessaloniki | 57010 | Greece |
| HUN005 | Tatabánya | Komárom-Esztergom | 2800 | Hungary |
| IRL003 | Dublin | 15 | Ireland |
| IRL002 | Dublin | Dublin 8 | Ireland |
| IRL001 | Limerick | V94 F858 | Ireland |
| ISR001 | Ashkelon | 78278 | Israel |
| ISR010 | Beersheba | 84101 | Israel |
| ISR008 | Haifa | 34362 | Israel |
| ISR006 | Jerusalem | 91031 | Israel |
| ISR002 | Jerusalem | 91120 | Israel |
| ISR009 | Kefar Sava | 44281 | Israel |
| ISR011 | Petah Tikva | 49100 | Israel |
| ISR007 | Ramat Gan | 52621 | Israel |
| ISR003 | Rehovot | 76100 | Israel |
| ISR004 | Ẕerifin | 70300 | Israel |
| ITA010 | Bologna | Emilia-Romagna | 40138 | Italy |
| ITA008 | Ferrara | Emilia-Romagna | 44124 | Italy |
| ITA002 | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| ITA006 | Milan | Lombardy | 20122 | Italy |
| ITA012 | Milan | Lombardy | 20122 | Italy |
| ITA011 | Rozzano | Lombardy | 20089 | Italy |
| ITA004 | Siena | Tuscany | 53100 | Italy |
| ITA003 | Milan | 20157 | Italy |
| ITA001 | Palermo | 90127 | Italy |
| ITA007 | Pavia | 27100 | Italy |
| ITA009 | Roma | 00168 | Italy |
| JPN029 | Toyoake | Aiti | 470-1192 | Japan |
| JPN031 | Toon-Shi | Ehime | 791-0203 | Japan |
| JPN027 | Fukuoka | Hukuoka | 815-0032 | Japan |
| JPN023 | Iizuka-Shi | Hukuoka | 820-0018 | Japan |
| JPN009 | Kobe | Hyôgo | 650-0047 | Japan |
| JPN020 | Kasama-Shi | Ibaraki | 309-1703 | Japan |
| JPN001 | Naka-gun | Ibaraki | 319-1113 | Japan |
| JPN022 | Takamatsu | Kagawa-ken | 761-8073 | Japan |
| JPN028 | Yokohama-Shi Konan-Ku | Kanagawa | 234-0054 | Japan |
| JPN005 | Koshi Shi | Kumamoto | 861-1196 | Japan |
| JPN008 | Matsusaka-shi | Mie-ken | 515-8544 | Japan |
| JPN011 | Tsu | Mie-ken | 514-1101 | Japan |
| JPN034 | Sendai | Miyagi | 981-0914 | Japan |
| JPN013 | Nagasaki | Nagasaki | 852-8501 | Japan |
| JPN012 | Chuo-ku | Niigata | 951-8510 | Japan |
| JPN015 | Matsue | Shimane | 690-8556 | Japan |
| JPN007 | Kiyose | Tokyo | 204-8522 | Japan |
| JPN014 | Ōta-ku | Tokyo | 143-8541 | Japan |
| JPN006 | Shinagawa-ku | Tokyo | 140-8522 | Japan |
| JPN017 | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| JPN002 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| JPN032 | Shinjuku-ku | Tokyo | 1628655 | Japan |
| JPN019 | Shimonoseki-Shi | Yamaguchi | 750-0041 | Japan |
| JPN030 | Fukuoka | 8408571 | Japan |
| JPN003 | Hamamatsu | 434-8511 | Japan |
| JPN004 | Kita Kyushu-shi | 807-8556 | Japan |
| JPN016 | Matsue | 690-8504 | Japan |
| JPN010 | Meguro-ku | 152-0021 | Japan |
| JPN018 | Toyonaka-shi | 560-8552 | Japan |
| LVA002 | Daugavpils | Daugavpils Aprinkis | LV-5401 | Latvia |
| LVA005 | Jūrmala | LV-2015 | Latvia |
| MYS004 | Kuantan | Pahang | 25100 | Malaysia |
| MYS001 | Kuala Lumpur | WilayahPersekutuan KualaLumpur | 50603 | Malaysia |
| MYS003 | Kota Bharu | 16150 | Malaysia |
| MYS005 | Kuala Lumpur | 50590 | Malaysia |
| MEX007 | Guadalajara | Jalisco | 44160 | Mexico |
| MEX008 | Guadalajara | Jalisco | 44160 | Mexico |
| MEX005 | Guadalajara | Jalisco | 44220 | Mexico |
| MEX004 | Guadalajara | Jalisco | 44700 | Mexico |
| MEX003 | Monterrey | Nuevo León | 64460 | Mexico |
| MEX006 | Durango | 34080 | Mexico |
| MEX001 | Monterrey | 64718 | Mexico |
| MEX002 | Oaxaca City | 68000 | Mexico |
| NLD003 | Arnhem | Gelderland | 6815 AD | Netherlands |
| NLD001 | Alkmaar | North Holland | 1815 JD | Netherlands |
| NLD002 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| NLD006 | Rotterdam | 3015 GD | Netherlands |
| NZL006 | Otahuhu | Auckland | 1640 | New Zealand |
| NZL009 | Hastings | Hawkes's Bay | 4122 | New Zealand |
| NZL005 | Christchurch | South Island | 8011 | New Zealand |
| NZL001 | Dunedin | South Island | 9001 | New Zealand |
| NZL002 | Hamilton | Waikato Region | 3204 | New Zealand |
| NZL011 | Paraparaumu | Wellington Region | 5032 | New Zealand |
| NZL003 | Auckland | 1051 | New Zealand |
| NZL008 | Auckland | 1051 | New Zealand |
| NZL007 | Tauranga | 3110 | New Zealand |
| NZL010 | Wellington | 6021 | New Zealand |
| PER005 | Chancay | 15131 | Peru |
| PER001 | Lima | 15001 | Peru |
| PER003 | Lima | 15036 | Peru |
| PER002 | Lima | 15084 | Peru |
| PER006 | Piura | 20001 | Peru |
| POL005 | Bialystok | 15-044 | Poland |
| POL006 | Bielsko-Biala | 43-300 | Poland |
| POL016 | Katowice | 40-081 | Poland |
| POL015 | Kielce | 25-751 | Poland |
| POL017 | Krakow | 30-510 | Poland |
| POL018 | Ksawerów | 95-054 | Poland |
| POL008 | Rabka-Zdrój | 34-700 | Poland |
| POL011 | Rzeszów | 35-051 | Poland |
| POL010 | Siedlce | 08-110 | Poland |
| POL007 | Sosnowiec | 41-208 | Poland |
| POL001 | Sucha Beskidzka | 34-200 | Poland |
| POL014 | Szczecin | 70-111 | Poland |
| POL009 | Tarnów | 33-100 | Poland |
| POL012 | Ostrowiec Świętokrzyski | Świętokrzyskie Voivodeship | 27-400 | Poland |
| PRT005 | Aveiro | 3814-501 | Portugal |
| PRT009 | Braga | 4710-243 | Portugal |
| PRT006 | Guarda | 6300-858 | Portugal |
| PRT002 | Guimarães | 4835-044 | Portugal |
| PRT003 | Lisbon | 1649-035 | Portugal |
| SRB001 | Belgrade | 11000 | Serbia |
| SRB003 | Belgrade | 11000 | Serbia |
| SRB007 | Niš | 18000 | Serbia |
| SRB014 | Sombor | 25000 | Serbia |
| SRB010 | Užice | 31000 | Serbia |
| SVK002 | Bardejov | 085 01 | Slovakia |
| SVK003 | Spisská Nová Ves | 052 01 | Slovakia |
| KOR015 | Ansan-si | Gyeonggido | 15355 | South Korea |
| KOR008 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| KOR007 | Seongnam-si | Gyeonggido | 13620 | South Korea |
| KOR003 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| KOR004 | Incheon | 21431 | South Korea |
| KOR012 | Seoul | 02447 | South Korea |
| KOR011 | Seoul | 02841 | South Korea |
| KOR009 | Seoul | 03312 | South Korea |
| KOR013 | Seoul | 03722 | South Korea |
| KOR010 | Seoul | 06273 | South Korea |
| KOR005 | Seoul | 06591 | South Korea |
| ESP009 | Santiago de Compostela | A Coruña | 15706 | Spain |
| ESP013 | Badalona | Barcelona | 08036 | Spain |
| ESP012 | Santander | Cantabria | 39008 | Spain |
| ESP015 | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| ESP011 | Pamplona | Navarre | 31008 | Spain |
| ESP008 | Oviedo | Principality of Asturias | 33011 | Spain |
| ESP003 | Barcelona | 08035 | Spain |
| ESP016 | Barcelona | 8036 | Spain |
| ESP001 | Girona | 17007 | Spain |
| ESP006 | L'Hospitalet de Llobregat | 08907 | Spain |
| ESP007 | Madrid | 28007 | Spain |
| ESP002 | Madrid | Spain |
| TWN003 | Kaohsiung City | 80756 | Taiwan |
| TWN002 | Kaohsiung City | 82544 | Taiwan |
| TWN001 | Kaohsiung City | 833 | Taiwan |
| TWN005 | New Taipei City | 22060 | Taiwan |
| TWN007 | Taipei | 10002 | Taiwan |
| TWN004 | Taipei | 11217 | Taiwan |
| TWN006 | Taipei | 11490 | Taiwan |
| THA004 | Nakhonnayok | Changwat Nakhon Nayok | 26120 | Thailand |
| THA002 | Muang | Changwat Nonthaburi | 11000 | Thailand |
| THA003 | Khon Kaen | 40002 | Thailand |
| TUR006 | Atakum | Samsun | 55270 | Turkey (Türkiye) |
| TUR010 | Ankara | 6010 | Turkey (Türkiye) |
| TUR011 | Ankara | 6340 | Turkey (Türkiye) |
| TUR003 | Çanakkale | 17110 | Turkey (Türkiye) |
| TUR008 | Izmir | 35100 | Turkey (Türkiye) |
| TUR004 | Izmir | 35110 | Turkey (Türkiye) |
| TUR009 | Kocaeli | 41380 | Turkey (Türkiye) |
| TUR005 | Konya | 42075 | Turkey (Türkiye) |
| TUR001 | Mersin | 33079 | Turkey (Türkiye) |
| UKR001 | Kharkiv | Kharkiv Oblast | 61124 | Ukraine |
| UKR007 | Kherson | Kherson Oblast | 73003 | Ukraine |
| UKR005 | Poltava | Poltava Oblast | 36010 | Ukraine |
| UKR012 | Dnipro | 49102 | Ukraine |
| UKR009 | Ivano-Frankivsk | 76018 | Ukraine |
| UKR008 | Kyiv | 01033 | Ukraine |
| UKR004 | Kyiv | 03038 | Ukraine |
| UKR003 | Odesa | 65025 | Ukraine |
| UKR010 | Vinnytsia | 21018 | Ukraine |
| GBR001 | Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| GBR015 | Exeter | Devon | EX2 5DW | United Kingdom |
| GBR017 | Norwich | Norfolk | NR4 7UY | United Kingdom |
| GBR013 | Llandough | Vale of Glamorgan, the | CF64 2XX | United Kingdom |
| GBR016 | Bradford | Yorkshire | BD9 6RJ | United Kingdom |
| GBR006 | Birmingham | B9 5SS | United Kingdom |
| GBR002 | Chertsey | KT16 0PZ | United Kingdom |
| GBR007 | Dundee | DDI 9SY | United Kingdom |
| GBR004 | Liverpool | L14 3PE | United Kingdom |
| GBR009 | London | SW3 6NP | United Kingdom |
| GBR008 | Manchester | M23 9LT | United Kingdom |
| GBR011 | Manchester | M8 5RB | United Kingdom |
| GBR003 | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| GBR012 | Salford | M6 8HD | United Kingdom |
| GBR018 | Southampton | SO16 6YD | United Kingdom |
| GBR010 | Swansea | SA6 6NL | United Kingdom |
| Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Loebinger MR, McShane PJ, Ringshausen FC, Blasi F, Shteinberg M, Mange K, Teper A, Fernandez C, Zambrano M, Fan C, Zhang X, Metersky ML; ASPEN Investigators. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2025 Apr 24;392(16):1569-1581. doi: 10.1056/NEJMoa2411664. |
| 39040578 | Derived | Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Mange K, Teper A, Fernandez C, Conroy D, Metersky M. Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics. ERJ Open Res. 2024 Jul 22;10(4):00151-2024. doi: 10.1183/23120541.00151-2024. eCollection 2024 Jul. |
| 35976570 | Derived | Chalmers JD, Usansky H, Rubino CM, Teper A, Fernandez C, Zou J, Mange KC. Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. Clin Pharmacokinet. 2022 Oct;61(10):1457-1469. doi: 10.1007/s40262-022-01147-w. Epub 2022 Jul 25. |
| FG002 | Placebo | Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-treat (ITT) analysis set included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brensocatib 10 mg | Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks. |
| BG001 | Brensocatib 25 mg | Participants received brensocatib 25 mg tablets orally, once daily, for 52 weeks. |
| BG002 | Placebo | Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Rate of Pulmonary Exacerbations (PEs) | 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. | The ITT analysis set included all participants who were randomized. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Up to Week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First PE | 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. | The ITT analysis set included all participants who were randomized. | Posted | Median | 95% Confidence Interval | weeks | Up to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Responder Status for Exacerbation-Free Over the 52-Week Treatment Period | 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. | The ITT analysis set included all participants who were randomized. | Posted | Number | percentage of participants | Up to Week 52 |
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| Secondary | Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1) | 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. | 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. | Posted | Least Squares Mean | Standard Error | liter (L) | Baseline, Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Rate of Severe PEs | 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. | The ITT analysis set included all participants who were randomized. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Up to Week 52 |
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| Secondary | Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline, Week 52 |
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| Secondary | Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) | 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. | The Safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo. | Posted | Count of Participants | Participants | Up to Week 56 |
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| Secondary | Plasma Concentration of Brensocatib in Adults (Main Study) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/ml) | 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 |
|
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| Secondary | Plasma Concentration of Brensocatib in Adults (PK Substudy) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | 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 |
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| Secondary | Plasma Concentration of Brensocatib in Adolescents (Main Study) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | 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 |
|
|
Up to Week 56
The safety analysis set included all participants who were randomized and received at least 1 dose of brensocatib or placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brensocatib 10 mg | Participants received brensocatib 10 mg tablets, orally, once daily, for 52 weeks. | 2 | 582 | 101 | 582 | 197 | 582 |
| EG001 | Brensocatib 25 mg | Participants received brensocatib 25 mg tablets, orally, once daily, for 52 weeks. | 4 | 574 | 97 | 574 | 213 | 574 |
| EG002 | Placebo | Participants received a brensocatib matching placebo tablets orally, once daily, for 52 weeks. | 8 | 563 | 108 | 563 | 203 | 563 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Blindness transient | Eye disorders | 27.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 27.0 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | 27.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | 27.0 | Systematic Assessment |
| |
| Macular hole | Eye disorders | 27.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | 27.0 | Systematic Assessment |
| |
| Vitreoretinal traction syndrome | Eye disorders | 27.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Femoral hernia incarcerated | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 27.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Biliary cyst | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Bronchitis fungal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Burkholderia gladioli infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Gastroenteritis cryptosporidial | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Scrub typhus | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Foreign body in throat | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Urinary sediment abnormal | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | 27.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Pelvic organ prolapse | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Uterovaginal prolapse | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Insmed Medical Information | Insmed Incorporated | 1-844-446-7633 | medicalinformation@Insmed.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2024 | Oct 27, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000619932 | brensocatib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Unknown or Not Reported |
|
| More than one race |
|
| Model treatment & randomization stratification factor=geographic region, sputum sample (Pseudomonas aeruginosa) at start & PE last 12 months, age group (fixed effects) & time at risk (log scale) as offset variable. Robust sandwich covariance estimator used. | Negative binomial regression | =0.0046 | Adjusted p-value = 0.0048. The enhanced mixture-based gatekeeping procedure was used to control the overall type I error rate. Multiplicity adjusted p-value for the primary endpoint was tested at two-sided alpha = 0.01. | Rate ratio | 0.806 | 2-Sided | 95 | 0.694 | 0.936 | Superiority |
| OG002 |
| Placebo |
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks. |
|
|
|
| OG002 | Placebo | Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks. |
|
|
|
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks.
|
|
|
| Placebo |
Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks. |
|
|
|
| OG002 | Placebo | Participants received a brensocatib matching placebo, tablets orally, once daily, for 52 weeks. |
|
|
|
|
|
|
|
|