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A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594369
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Cystic Fibrosis Bronchiectasis Drug: Brensocatib 10 mg Drug: Brensocatib 25 mg Drug: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : March 22, 2024
Estimated Study Completion Date : March 22, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Brensocatib 10 mg
Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
 Drug: Brensocatib 10 mg
Oral tablet.
Other Name: INS1007
Experimental: Brensocatib 25 mg
Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
 Drug: Brensocatib 25 mg
Oral tablet.
Other Name: INS1007
Placebo Comparator: Placebo
Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.
 Drug: Placebo
Brensocatib-matching oral tablet.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Adjudicated Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  1. Time to First Adjudicated 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) [ Time Frame: Baseline, at Week 52 ]
  4. Rate of Severe Adjudicated 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 in Adult Participants [ Time Frame: Baseline to Week 52 ]
  6. Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 56 Weeks ]
  7. Plasma Concentration of Brensocatib at Select Time Points [ Time Frame: Pre-dose and post-dose at multiple time points up to Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594369


Contacts
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Contact: Insmed Medical Information 1-844-446-7633 medicalinformation@insmed.com

Locations
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Sponsors and Collaborators
Insmed Incorporated
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT04594369    
Other Study ID Numbers: INS1007-301
2020-003688-25 ( EudraCT Number )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Insmed Incorporated:
ASPEN
Brensocatib
INS1007
Additional relevant MeSH terms:
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Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases