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Trial record 1 of 1 for:    Aspen INS1007-301 | Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis
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A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)

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ClinicalTrials.gov Identifier: NCT04594369
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Tracking Information
First Submitted Date  ICMJE October 14, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date September 8, 2021
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
Rate of Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • Time to First Pulmonary Exacerbation (PE) [ Time Frame: 52 Weeks ]
  • Percentage of Participants who are Pulmonary Exacerbation (PE) Free [ Time Frame: 52 Weeks ]
  • Change from Baseline in Postbronchodilator Forced Expiratory Volume in 1 second (FEV1) Measurements [ Time Frame: Baseline to Week 52 ]
  • Rate of Severe Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]
  • 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 ]
  • Incidence and Severity of Treatment-Emergent Adverse Events [ Time Frame: 56 Weeks ]
  • Maximum Observed Concentration (Cmax) of Brensocatib at Steady State [ Time Frame: 56 Weeks ]
  • Time to Maximum Concentration (Tmax) of Brensocatib at Steady State [ Time Frame: 56 Weeks ]
  • Area Under the Concentration Versus Time Curve (AUC) of Brensocatib at Steady State [ Time Frame: 56 Weeks ]
  • Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score [ Time Frame: Baseline to Week 52 ]
  • Incidence and severity of treatment-emergent adverse events [ Time Frame: Up to Week 56 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • Time to First Pulmonary Exacerbation (PE) [ Time Frame: 52 Weeks ]
  • Percentage of Participants who are Pulmonary Exacerbation (PE) Free [ Time Frame: 52 Weeks ]
  • Change from Baseline in Postbronchodilator Forced Expiratory Volume in 1 second (FEV1) Measurements [ Time Frame: Baseline to Week 52 ]
  • Rate of Severe Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]
  • Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score [ Time Frame: Baseline to Week 52 ]
  • Incidence and severity of treatment-emergent adverse events [ Time Frame: Up to Week 56 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Cystic Fibrosis Bronchiectasis
Intervention  ICMJE
  • Drug: Brensocatib 10 mg
    Oral tablet.
    Other Name: INS1007
  • Drug: Brensocatib 25 mg
    Oral tablet.
    Other Name: INS1007
  • Drug: Placebo
    Brensocatib-matching oral tablet.
Study Arms  ICMJE
  • Experimental: Brensocatib 10 mg
    Participants will receive brensocatib 10 mg once daily, for 52 weeks.
    Intervention: Drug: Brensocatib 10 mg
  • Experimental: Brensocatib 25 mg
    Participants will receive brensocatib 25 mg once daily, for 52 weeks.
    Intervention: Drug: Brensocatib 25 mg
  • Placebo Comparator: Placebo
    Participants will receive a brensocatib-matching placebo once daily.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2020)
1620
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 subjects with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.

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.
  • Have compliance issues with completion of electronic diary entries (<75%) during the Screening Period AND in the opinion of the Investigator, compliance is unlikely to improve during the study.
  • 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.
  • Known history of hypersensitivity to brensocatib or any of its excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Insmed Medical Information 844-4-INSMED medicalinformation@insmed.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bulgaria,   Canada,   Chile,   Denmark,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Netherlands,   New Zealand,   Peru,   Poland,   Portugal,   Serbia,   Spain,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04594369
Other Study ID Numbers  ICMJE INS1007-301
2020-003688-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Insmed Incorporated
Study Sponsor  ICMJE Insmed Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Insmed Incorporated
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP