Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

USA013
Birmingham, Alabama 35233

USA044
Little Rock, Arkansas 72205

USA055
Los Angeles, California 90048

USA029
Newport Beach, California 92663

USA102
Northridge, California 91324-3138

USA022
Palm Springs, California 92262

USA042
Palm Springs, California 92262

USA035
San Diego, California 92120

USA078
Santa Barbara, California 93102

USA027
Ventura, California 93303

USA008
Lafayette, Colorado 80026

USA017
Farmington, Connecticut 06030

USA001
Washington, District of Columbia 20007

USA054
Brandon, Florida 33511

USA015
Clearwater, Florida 33765

USA062
Fort Lauderdale, Florida 33316

USA007
Kissimmee, Florida 34741

USA039
Kissimmee, Florida 34746

USA019
Miami Lakes, Florida 33014

USA037
Miami, Florida 33126

USA049
Naples, Florida 34102

USA052
Orlando, Florida 32825

USA058
Sebring, Florida 33870

USA061
Maywood, Illinois 60153

USA063
Iowa City, Iowa 52242-1009

USA031
Kansas City, Kansas 66160

USA020
New Orleans, Louisiana 70112

USA051
New Orleans, Louisiana 70112

USA003
Baltimore, Maryland 21205

USA047
Columbia, Maryland 21044-3078

USA025
Towson, Maryland 21286

USA064
Springfield, Massachusetts 01199

USA010
Rochester, Minnesota 55905

USA006
Chesterfield, Missouri 63017

USA059
Saint Louis, Missouri 63110

USA009
Omaha, Nebraska 68131

USA065
Toms River, New Jersey 08755

USA069
Liverpool, New York 13088

USA066
New Hyde Park, New York 11042

USA068
New Hyde Park, New York 11042

USA072
New Hyde Park, New York 11042

USA075
New Hyde Park, New York 11042

USA080
New Hyde Park, New York 11042

USA084
New Hyde Park, New York 11042

USA089
New Hyde Park, New York 11042

USA091
New Hyde Park, New York 11042

USA021
New York, New York 10016

USA045
New York, New York 10029-6504

USA048
Charlotte, North Carolina 28277

USA033
Gastonia, North Carolina 28054

USA096
Huntersville, North Carolina 28078-5082

USA026
Winston-Salem, North Carolina 27103

USA023
Portland, Oregon 97239

USA038
DuBois, Pennsylvania 15801

USA046
Philadelphia, Pennsylvania 19104

USA005
Charleston, South Carolina 29425

USA067
Clinton, South Carolina 29325-7556

USA071
Clinton, South Carolina 29325-7556

USA074
Clinton, South Carolina 29325-7556

USA077
Clinton, South Carolina 29325-7556

USA081
Clinton, South Carolina 29325-7556

USA088
Clinton, South Carolina 29325-7556

USA090
Clinton, South Carolina 29325-7556

USA094
Clinton, South Carolina 29325-7556

USA036
Rock Hill, South Carolina 29732

USA041
Franklin, Tennessee 37067

USA043
Cypress, Texas 77429

USA087
Galveston, Texas 77555

USA050
McKinney, Texas 75069

USA018
Mesquite, Texas 75149

USA011
San Antonio, Texas 78258

USA002
Tyler, Texas 75708

USA034
Williamsburg, Virginia 23188

More Details

NCT ID
NCT04594369
Status
Recruiting
Sponsor
Insmed Incorporated

Study Contact

Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.