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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04594369




Registration number
NCT04594369
Ethics application status
Date submitted
14/10/2020
Date registered
20/10/2020

Titles & IDs
Public title
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Scientific 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
Secondary ID [1] 0 0
2020-003688-25
Secondary ID [2] 0 0
INS1007-301
Universal Trial Number (UTN)
Trial acronym
ASPEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Brensocatib 10 mg
Treatment: Drugs - Brensocatib 25 mg
Treatment: Drugs - Placebo

Experimental: Brensocatib 10 mg - Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.

Experimental: Brensocatib 25 mg - Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.

Placebo comparator: Placebo - Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.


Treatment: Drugs: Brensocatib 10 mg
Oral tablet.

Treatment: Drugs: Brensocatib 25 mg
Oral tablet.

Treatment: Drugs: Placebo
Brensocatib-matching oral tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Adjudicated Pulmonary Exacerbations (PEs)
Timepoint [1] 0 0
52 Weeks
Secondary outcome [1] 0 0
Time to First Adjudicated Pulmonary Exacerbation (PE)
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Percentage of Participants who are Pulmonary Exacerbation (PE) Free
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [3] 0 0
Baseline, at Week 52
Secondary outcome [4] 0 0
Rate of Severe Adjudicated Pulmonary Exacerbations (PEs)
Timepoint [4] 0 0
52 Weeks
Secondary outcome [5] 0 0
Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
56 Weeks
Secondary outcome [7] 0 0
Plasma Concentration of Brensocatib at Select Time Points
Timepoint [7] 0 0
Pre-dose and post-dose at multiple time points up to Week 52

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/03/2024
Actual
Sample size
Target
Accrual to date
Final
1767
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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AUS013 - Kogarah
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4870 - Cairns North
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4120 - Greenslopes
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4101 - South Brisbane
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5000 - Adelaide
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5042 - Bedford Park
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5006 - North Adelaide
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5011 - Woodville South
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3128 - Box Hill
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3168 - Clayton
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6150 - Murdoch
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6009 - Nedlands
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NSW 2139 - Concord
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6163 - Spearwood
Recruitment outside Australia
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Aveiro
Country [190] 0 0
Portugal
State/province [190] 0 0
Braga
Country [191] 0 0
Portugal
State/province [191] 0 0
Guarda
Country [192] 0 0
Portugal
State/province [192] 0 0
Guimaraes
Country [193] 0 0
Portugal
State/province [193] 0 0
Lisboa
Country [194] 0 0
Serbia
State/province [194] 0 0
Belgrade
Country [195] 0 0
Serbia
State/province [195] 0 0
Nis
Country [196] 0 0
Serbia
State/province [196] 0 0
Sombor
Country [197] 0 0
Serbia
State/province [197] 0 0
Uzice
Country [198] 0 0
Slovakia
State/province [198] 0 0
Bardejov
Country [199] 0 0
Slovakia
State/province [199] 0 0
Spisská Nová Ves
Country [200] 0 0
Spain
State/province [200] 0 0
A Coruña
Country [201] 0 0
Spain
State/province [201] 0 0
Asturias
Country [202] 0 0
Spain
State/province [202] 0 0
Barcelona
Country [203] 0 0
Spain
State/province [203] 0 0
Cantabria
Country [204] 0 0
Spain
State/province [204] 0 0
Madrid
Country [205] 0 0
Spain
State/province [205] 0 0
Navarra
Country [206] 0 0
Spain
State/province [206] 0 0
Girona
Country [207] 0 0
Spain
State/province [207] 0 0
L´Hospitalet de Llobregat
Country [208] 0 0
Taiwan
State/province [208] 0 0
Kaohsiung City
Country [209] 0 0
Taiwan
State/province [209] 0 0
Kaohsiung
Country [210] 0 0
Taiwan
State/province [210] 0 0
New Taipei City
Country [211] 0 0
Taiwan
State/province [211] 0 0
Taipei City
Country [212] 0 0
Taiwan
State/province [212] 0 0
Taipei
Country [213] 0 0
Thailand
State/province [213] 0 0
Nakhon Nayok
Country [214] 0 0
Thailand
State/province [214] 0 0
Nonthaburi
Country [215] 0 0
Thailand
State/province [215] 0 0
Khon Kaen
Country [216] 0 0
Turkey
State/province [216] 0 0
Samsun
Country [217] 0 0
Turkey
State/province [217] 0 0
Ankara
Country [218] 0 0
Turkey
State/province [218] 0 0
Canakkale
Country [219] 0 0
Turkey
State/province [219] 0 0
Izmir
Country [220] 0 0
Turkey
State/province [220] 0 0
Kocaeli
Country [221] 0 0
Turkey
State/province [221] 0 0
Konya
Country [222] 0 0
Turkey
State/province [222] 0 0
Mersin
Country [223] 0 0
Ukraine
State/province [223] 0 0
Kharkivs'ka Oblast
Country [224] 0 0
Ukraine
State/province [224] 0 0
Khersons'ka Oblast
Country [225] 0 0
Ukraine
State/province [225] 0 0
Poltavs'ka Oblast
Country [226] 0 0
Ukraine
State/province [226] 0 0
Dnipro
Country [227] 0 0
Ukraine
State/province [227] 0 0
Ivano-Frankivsk
Country [228] 0 0
Ukraine
State/province [228] 0 0
Kyiv
Country [229] 0 0
Ukraine
State/province [229] 0 0
Odesa
Country [230] 0 0
Ukraine
State/province [230] 0 0
Vinnytsia
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Cambridgeshire
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Devon
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Norfolk
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Vale Of Glamorgan, The
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Yorkshire
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Birmingham
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Chertsey
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Dundee
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Liverpool
Country [240] 0 0
United Kingdom
State/province [240] 0 0
London
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Manchester
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Newcastle upon Tyne
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Salford
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Southampton
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04594369