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History of Changes for Study: NCT04594369
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
Latest version (submitted September 27, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 14, 2020 None (earliest Version on record)
2 November 19, 2020 Study Status and IPDSharing
3 December 1, 2020 Recruitment Status, Contacts/Locations and Study Status
4 December 10, 2020 Study Status
5 March 11, 2021 Study Status and Contacts/Locations
6 March 25, 2021 Contacts/Locations and Study Status
7 April 9, 2021 Study Status and Contacts/Locations
8 April 22, 2021 Contacts/Locations and Study Status
9 June 7, 2021 Contacts/Locations, Study Status and Outcome Measures
10 June 21, 2021 Contacts/Locations and Study Status
11 June 24, 2021 Contacts/Locations and Study Status
12 June 30, 2021 Eligibility and Study Status
13 July 9, 2021 Study Status and Contacts/Locations
14 July 23, 2021 Contacts/Locations and Study Status
15 August 9, 2021 Contacts/Locations and Study Status
16 August 23, 2021 Contacts/Locations and Study Status
17 September 7, 2021 Study Status and Contacts/Locations
18 October 8, 2021 Contacts/Locations and Study Status
19 October 28, 2021 Contacts/Locations and Study Status
20 October 29, 2021 Contacts/Locations and Study Status
21 November 10, 2021 Study Status and Contacts/Locations
22 December 3, 2021 Contacts/Locations and Study Status
23 March 4, 2022 Contacts/Locations and Study Status
24 March 25, 2022 Contacts/Locations and Study Status
25 April 5, 2022 Contacts/Locations and Study Status
26 April 12, 2022 Contacts/Locations and Study Status
27 April 22, 2022 Contacts/Locations, Outcome Measures, Eligibility, Arms and Interventions and Study Status
28 May 13, 2022 Contacts/Locations and Study Status
29 May 25, 2022 Contacts/Locations and Study Status
30 June 7, 2022 Contacts/Locations and Study Status
31 June 20, 2022 Contacts/Locations and Study Status
32 July 11, 2022 Contacts/Locations and Study Status
33 July 27, 2022 Contacts/Locations and Study Status
34 August 1, 2022 Study Status and Contacts/Locations
35 August 18, 2022 Contacts/Locations and Study Status
36 August 30, 2022 Contacts/Locations and Study Status
37 September 12, 2022 Contacts/Locations and Study Status
38 September 27, 2022 Contacts/Locations and Study Status
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Study NCT04594369
Submitted Date:  October 14, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: INS1007-301
Brief Title: A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
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
Secondary IDs: 2020-003688-25 [EudraCT Number]
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: November 1, 2020
Primary Completion: March 1, 2024 [Anticipated]
Study Completion: March 1, 2024 [Anticipated]
First Submitted: October 14, 2020
First Submitted that
Met QC Criteria:
October 14, 2020
First Posted: October 20, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 14, 2020
Last Update Posted: October 20, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Insmed Incorporated
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: ASPEN
Brensocatib
INS1007
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 1620 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Brensocatib 10 mg
Participants will receive brensocatib 10 mg once daily, for 52 weeks.
Drug: Brensocatib 10 mg
Oral tablet.
Other Names:
  • INS1007
Experimental: Brensocatib 25 mg
Participants will receive brensocatib 25 mg once daily, for 52 weeks.
Drug: Brensocatib 25 mg
Oral tablet.
Other Names:
  • INS1007
Placebo Comparator: Placebo
Participants will receive a brensocatib-matching placebo once daily.
Drug: Placebo
Brensocatib-matching oral tablet.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of Pulmonary Exacerbations (PEs)
[ Time Frame: 52 Weeks ]

Secondary Outcome Measures:
1. Time to First Pulmonary Exacerbation (PE)
[ Time Frame: 52 Weeks ]

2. Percentage of Participants who are Pulmonary Exacerbation (PE) Free
[ Time Frame: 52 Weeks ]

3. Change from Baseline in Postbronchodilator Forced Expiratory Volume in 1 second (FEV1) Measurements
[ Time Frame: Baseline to Week 52 ]

4. Rate of Severe Pulmonary Exacerbations (PEs)
[ Time Frame: 52 Weeks ]

5. Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score
[ Time Frame: Baseline to Week 52 ]

6. Incidence and severity of treatment-emergent adverse events
[ Time Frame: Up to Week 56 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Provide their signed study informed consent to participate.
  • Clinical history consistent with non-cystic fibrosis bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan.
  • At least 2 pulmonary exacerbations 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.
  • Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective double barrier contraception (ie, methods that in combination achieve <1% unintended pregnancy rates per year) 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.

Exclusion Criteria:

  • A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
  • Bronchiectasis due to cystic fibrosis.
  • Current smokers as defined per Centers for Disease Control (CDC).
  • Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
  • Active and current symptomatic infection by COVID-19.
  • Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
  • Receiving medications or therapy that are prohibited as concomitant medications.
  • Previously participated in a clinical trial of brensocatib.
  • Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib.
  • Suffering an exacerbation 4 weeks before Screening or during the Screening period.
  • Unable to comply with ≥75% of completion of electronic diary entries or have compliance issues during the Screening Period.
  • Participated in any other interventional clinical studies within 3 months before Screening Visit.
  • History of alcohol or drug abuse within 6 months prior to the Screening Visit.
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Christine Syltevik
Telephone: 908-655-1817
Email: Christine.Syltevik@insmed.com
Central Contact Backup: Tomoko Shibata
Telephone: 732-487-7292
Email: Tomoko.Shibata@Insmed.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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