Clinical trial NCT04594369: A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: ASPEN
Brensocatib
INS1007
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 1767
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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:

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

Primary outcomes:
measure: Rate of Adjudicated Pulmonary Exacerbations (PEs)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Time to First Adjudicated Pulmonary Exacerbation (PE)
timeFrame: 52 Weeks
measure: Percentage of Participants who are Pulmonary Exacerbation (PE) Free
timeFrame: 52 Weeks
measure: Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, at Week 52
measure: Rate of Severe Adjudicated Pulmonary Exacerbations (PEs)
timeFrame: 52 Weeks
measure: Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
timeFrame: Baseline to Week 52
measure: Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 56 Weeks
measure: Plasma Concentration of Brensocatib at Select Time Points
timeFrame: Pre-dose and post-dose at multiple time points up to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: USA013
state: Alabama
city: Conway
country: United States
facility: USA080
state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
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city: Los Angeles
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state: Región-MetropolitanadeSantiago
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state: Distrito Capital De Bogotá
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state: Bas-Rhin
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facility: FRA005
state: Hérault
city: Amiens cedex 1
country: France
facility: FRA004
city: Creteil
country: France
facility: FRA011
city: Nantes
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facility: FRA003
city: Nice
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facility: FRA009
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city: Heidelberg
country: Germany
facility: DEU009
state: Baden-Württemberg
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state: Brandenburg
city: Frankfurt am Main
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state: Hessen
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state: Komárom-Esztergom
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city: Palermo
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city: Toyoake
country: Japan
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country: Japan
facility: JPN027
state: Hukuoka
city: Iizuka-Shi
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state: Hukuoka
city: Kobe-City
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city: Kasama-Shi
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state: Ibaraki
city: Naka-gun
country: Japan
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state: Ibaraki
city: Takamatsu-Shi
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state: Kagawa
city: Yokohama-Shi Konan-Ku
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facility: JPN028
state: Kanagawa
city: Koshi shi
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state: Mie
city: Tsu
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state: Niigata
city: Matsue
country: Japan
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state: Simane
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city: Shinjuku-ku
country: Japan
facility: JPN032
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city: Fukuoka-shi
country: Japan
facility: JPN030
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country: Japan
facility: JPN003
city: Kita Kyushu-shi
country: Japan
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country: Japan
facility: JPN016
city: Meguro-ku
country: Japan
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city: Ansan-si
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country: Korea, Republic of
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state: Daugavpils Aprinkis
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country: Malaysia
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country: Malaysia
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state: Jalisco
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country: Mexico
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city: Guadalajara
country: Mexico
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state: Jalisco
city: Guadalajara
country: Mexico
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state: Jalisco
city: Monterrey
country: Mexico
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city: Durango
country: Mexico
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city: Monterrey
country: Mexico
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city: Oaxaca
country: Mexico
facility: MEX002
city: Arnhem
country: Netherlands
facility: NLD003
state: Gelderland
city: Alkmaar
country: Netherlands
facility: NLD001
state: Noord-Holland
city: Amsterdam
country: Netherlands
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state: Noord-Holland
city: Rotterdam
country: Netherlands
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country: New Zealand
facility: NZL006
state: Auckland
city: Hastings
country: New Zealand
facility: NZL009
state: Hawkes's Bay
city: Christchurch
country: New Zealand
facility: NZL005
state: South Island
city: Dunedin
country: New Zealand
facility: NZL001
state: South Island
city: Hamilton
country: New Zealand
facility: NZL002
state: Waikato
city: Paraparaumu
country: New Zealand
facility: NZL011
state: Wellington
city: Auckland
country: New Zealand
facility: NZL003
city: Auckland
country: New Zealand
facility: NZL008
city: Tauranga
country: New Zealand
facility: NZL007
city: Wellington
country: New Zealand
facility: NZL010
city: Chancay
country: Peru
facility: PER005
city: Lima
country: Peru
facility: PER001
city: Lima
country: Peru
facility: PER003
city: Lima
country: Peru
facility: PER002
city: Piura
country: Peru
facility: PER006
city: Ostrowiec Swietokrzyski
country: Poland
facility: POL012
state: Swietokrzyskie
city: Bialystok
country: Poland
facility: POL005
city: Bielsko Biala
country: Poland
facility: POL006
city: Katowice
country: Poland
facility: POL016
city: Kielce
country: Poland
facility: POL015
city: Krakow
country: Poland
facility: POL017
city: Ksawerow
country: Poland
facility: POL018
city: Rabka-Zdroj
country: Poland
facility: POL008
city: Rzeszów
country: Poland
facility: POL011
city: Siedlce
country: Poland
facility: POL010
city: Sosnowiec
country: Poland
facility: POL007
city: Sucha Beskidzka
country: Poland
facility: POL001
city: Szczecin
country: Poland
facility: POL014
city: Tarnow
country: Poland
facility: POL009
city: Aveiro
country: Portugal
facility: PRT005
city: Braga
country: Portugal
facility: PRT009
city: Guarda
country: Portugal
facility: PRT006
city: Guimaraes
country: Portugal
facility: PRT002
city: Lisboa
country: Portugal
facility: PRT003
city: Belgrade
country: Serbia
facility: SRB001
city: Belgrade
country: Serbia
facility: SRB003
city: Nis
country: Serbia
facility: SRB007
city: Sombor
country: Serbia
facility: SRB014
city: Uzice
country: Serbia
facility: SRB010
city: Bardejov
country: Slovakia
facility: SVK002
city: Spisská Nová Ves
country: Slovakia
facility: SVK003
city: Santiago de Compostela
country: Spain
facility: ESP009
state: A Coruña
city: Oviedo
country: Spain
facility: ESP008
state: Asturias
city: Badalona
country: Spain
facility: ESP013
state: Barcelona
city: Santander
country: Spain
facility: ESP012
state: Cantabria
city: Pozuelo de Alarcon
country: Spain
facility: ESP015
state: Madrid
city: Pamplona
country: Spain
facility: ESP011
state: Navarra
city: Barcelona
country: Spain
facility: ESP003
city: Barcelona
country: Spain
facility: ESP016
city: Girona
country: Spain
facility: ESP001
city: L´Hospitalet de Llobregat
country: Spain
facility: ESP006
city: Madrid
country: Spain
facility: ESP007
city: Madrid
country: Spain
facility: ESP002
city: Kaohsiung City
country: Taiwan
facility: TWN003
city: Kaohsiung
country: Taiwan
facility: TWN002
city: Kaohsiung
country: Taiwan
facility: TWN001
city: New Taipei City
country: Taiwan
facility: TWN005
city: Taipei City
country: Taiwan
facility: TWN006
city: Taipei
country: Taiwan
facility: TWN007
city: Taipei
country: Taiwan
facility: TWN004
city: Nakhonnayok
country: Thailand
facility: THA004
state: Nakhon Nayok
city: Muang
country: Thailand
facility: THA002
state: Nonthaburi
city: Khon Kaen
country: Thailand
facility: THA003
city: Atakum
country: Turkey
facility: TUR006
state: Samsun
city: Ankara
country: Turkey
facility: TUR010
city: Ankara
country: Turkey
facility: TUR011
city: Canakkale
country: Turkey
facility: TUR003
city: Izmir
country: Turkey
facility: TUR008
city: Izmir
country: Turkey
facility: TUR004
city: Kocaeli
country: Turkey
facility: TUR009
city: Konya
country: Turkey
facility: TUR005
city: Mersin
country: Turkey
facility: TUR001
city: Kharkiv
country: Ukraine
facility: UKR001
state: Kharkivs'ka Oblast
city: Kherson
country: Ukraine
facility: UKR007
state: Khersons'ka Oblast
city: Poltava
country: Ukraine
facility: UKR005
state: Poltavs'ka Oblast
city: Dnipro
country: Ukraine
facility: UKR012
city: Ivano-Frankivsk
country: Ukraine
facility: UKR009
city: Kyiv
country: Ukraine
facility: UKR008
city: Kyiv
country: Ukraine
facility: UKR004
city: Odesa
country: Ukraine
facility: UKR003
city: Vinnytsia
country: Ukraine
facility: UKR010
city: Cambridge
country: United Kingdom
facility: GBR001
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: GBR015
state: Devon
city: Norwich
country: United Kingdom
facility: GBR017
state: Norfolk
city: Llandough, Penarth
country: United Kingdom
facility: GBR013
state: Vale Of Glamorgan, The
city: Bradford
country: United Kingdom
facility: GBR016
state: Yorkshire
city: Birmingham
country: United Kingdom
facility: GBR006
city: Chertsey
country: United Kingdom
facility: GBR002
city: Dundee
country: United Kingdom
facility: GBR007
city: Liverpool
country: United Kingdom
facility: GBR004
city: London
country: United Kingdom
facility: GBR009
city: Manchester
country: United Kingdom
facility: GBR008
city: Manchester
country: United Kingdom
facility: GBR011
city: Newcastle upon Tyne
country: United Kingdom
facility: GBR003
city: Salford
country: United Kingdom
facility: GBR012
city: Southampton
country: United Kingdom
facility: GBR018
city: Swansea
country: United Kingdom
facility: GBR010
Study officials:
References:
citation: 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.