A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
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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 : May 22, 2023
|
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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 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 |
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. |
- Rate of Adjudicated Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]
- Time to First Adjudicated 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) [ Time Frame: Baseline, at Week 52 ]
- Rate of Severe Adjudicated 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 ]
- Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 56 Weeks ]
- Plasma Concentration of Brensocatib at Select Time Points [ Time Frame: Pre-dose and post-dose at multiple time points up to Week 52 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 85 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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.
- 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.
-
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.
- 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 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:
- 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 2019 corona virus disease (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 for 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.
- 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.
- 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.

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


United States, Alabama | |
USA013 | Active, not recruiting |
Birmingham, Alabama, United States, 35233-1711 | |
United States, Arkansas | |
USA059 | Active, not recruiting |
Conway, Arkansas, United States, 72032 | |
USA044 | Active, not recruiting |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
USA104 | Active, not recruiting |
Fresno, California, United States, 93702 | |
USA055 | Active, not recruiting |
Los Angeles, California, United States, 90048 | |
USA029 | Active, not recruiting |
Newport Beach, California, United States, 92663 | |
USA102 | Completed |
Northridge, California, United States, 91324-3138 | |
USA022 | Completed |
Palm Springs, California, United States, 92262 | |
USA024 | Active, not recruiting |
Sacramento, California, United States, 95817-1460 | |
USA035 | Completed |
San Diego, California, United States, 92120 | |
USA078 | Completed |
Santa Barbara, California, United States, 93105-4353 | |
USA027 | Recruiting |
Ventura, California, United States, 93003 | |
United States, Colorado | |
USA075 | Active, not recruiting |
Denver, Colorado, United States, 80206-2761 | |
USA008 | Active, not recruiting |
Lafayette, Colorado, United States, 80026 | |
United States, Connecticut | |
USA017 | Active, not recruiting |
Farmington, Connecticut, United States, 06030 | |
United States, District of Columbia | |
USA001 | Active, not recruiting |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
USA015 | Completed |
Clearwater, Florida, United States, 33765 | |
USA076 | Active, not recruiting |
Gainesville, Florida, United States, 32610-0001 | |
USA082 | Active, not recruiting |
Jacksonville, Florida, United States, 32224-1865 | |
USA039 | Active, not recruiting |
Kissimmee, Florida, United States, 34746 | |
USA072 | Active, not recruiting |
Leesburg, Florida, United States, 34748-5077 | |
USA019 | Active, not recruiting |
Miami Lakes, Florida, United States, 33014 | |
USA037 | Completed |
Miami, Florida, United States, 33126 | |
USA049 | Active, not recruiting |
Naples, Florida, United States, 34102-5444 | |
USA052 | Active, not recruiting |
Orlando, Florida, United States, 32825 | |
USA103 | Active, not recruiting |
Plantation, Florida, United States, 33324 | |
USA089 | Completed |
Saint Petersburg, Florida, United States, 33704 | |
USA074 | Completed |
Saint Petersburg, Florida, United States, 33707 | |
USA084 | Active, not recruiting |
Sarasota, Florida, United States, 34239-3509 | |
USA120 | Active, not recruiting |
Tampa, Florida, United States, 33606 | |
United States, Georgia | |
USA012 | Active, not recruiting |
Atlanta, Georgia, United States, 30342 | |
USA053 | Active, not recruiting |
Augusta, Georgia, United States, 30912 | |
United States, Illinois | |
USA073 | Active, not recruiting |
Chicago, Illinois, United States, 60611-2951 | |
USA061 | Active, not recruiting |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
USA115 | Active, not recruiting |
Hammond, Indiana, United States, 46324-2213 | |
United States, Iowa | |
USA063 | Active, not recruiting |
Iowa City, Iowa, United States, 52242 | |
United States, Kansas | |
USA031 | Active, not recruiting |
Kansas City, Kansas, United States, 66160 | |
United States, Louisiana | |
USA020 | Completed |
New Orleans, Louisiana, United States, 70112 | |
USA051 | Active, not recruiting |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
USA003 | Active, not recruiting |
Baltimore, Maryland, United States, 21224-3057 | |
United States, Massachusetts | |
USA079 | Active, not recruiting |
Boston, Massachusetts, United States, 02114 | |
USA064 | Active, not recruiting |
Springfield, Massachusetts, United States, 01199 | |
United States, Minnesota | |
USA010 | Active, not recruiting |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
USA006 | Completed |
Chesterfield, Missouri, United States, 63017 | |
USA122 | Recruiting |
Columbia, Missouri, United States, 65212-1000 | |
USA059 | Active, not recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
USA110 | Active, not recruiting |
Lincoln, Nebraska, United States, 68510 | |
United States, New Jersey | |
USA065 | Completed |
Toms River, New Jersey, United States, 08755 | |
United States, New York | |
USA095 | Active, not recruiting |
Bronx, New York, United States, 10461 | |
USA066 | Active, not recruiting |
New Hyde Park, New York, United States, 11042-1102 | |
USA021 | Active, not recruiting |
New York, New York, United States, 10017-6739 | |
USA085 | Active, not recruiting |
New York, New York, United States, 10032-3729 | |
United States, North Carolina | |
USA033 | Active, not recruiting |
Gastonia, North Carolina, United States, 28054 | |
USA096 | Active, not recruiting |
Huntersville, North Carolina, United States, 28078-5082 | |
USA026 | Active, not recruiting |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Ohio | |
USA067 | Completed |
Cincinnati, Ohio, United States, 45267 | |
USA028 | Recruiting |
Cleveland, Ohio, United States, 44106 | |
USA093 | Active, not recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
USA023 | Active, not recruiting |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
USA038 | Completed |
DuBois, Pennsylvania, United States, 15801 | |
USA046 | Active, not recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
USA005 | Active, not recruiting |
Charleston, South Carolina, United States, 29425 | |
USA036 | Completed |
Rock Hill, South Carolina, United States, 29732 | |
United States, Tennessee | |
USA041 | Active, not recruiting |
Franklin, Tennessee, United States, 37067 | |
USA109 | Active, not recruiting |
Nashville, Tennessee, United States, 37232-0028 | |
United States, Texas | |
USA097 | Active, not recruiting |
Dallas, Texas, United States, 75246-2081 | |
USA050 | Active, not recruiting |
McKinney, Texas, United States, 75069-8085 | |
USA011 | Active, not recruiting |
San Antonio, Texas, United States, 78258 | |
USA002 | Active, not recruiting |
Tyler, Texas, United States, 75708 | |
United States, Virginia | |
USA034 | Active, not recruiting |
Williamsburg, Virginia, United States, 23188 | |
United States, Washington | |
USA088 | Completed |
Vancouver, Washington, United States, 98664-1913 | |
Argentina | |
ARG027 | Recruiting |
Bahia Blanca, Buenos Aires, Argentina, 8000 | |
ARG021 | Active, not recruiting |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1121ABE | |
ARG022 | Active, not recruiting |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK | |
ARG002 | Active, not recruiting |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1414AIF | |
ARG001 | Active, not recruiting |
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425AZB | |
ARG003 | Completed |
Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina, C1425BEN | |
ARG004 | Active, not recruiting |
Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina, C1426ABP | |
ARG006 | Active, not recruiting |
la Plata, Buenos Aires, Argentina, B1902COS | |
ARG013 | Recruiting |
Mar del Plata, Buenos Aires, Argentina, B7600FYK | |
ARG017 | Active, not recruiting |
Mar Del Plata, Buenos Aires, Argentina, CP 7600 | |
ARG009 | Recruiting |
Villa Vatteone, Buenos Aires, Argentina, B1853AIK | |
ARG012 | Active, not recruiting |
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C10227AAP | |
ARG018 | Active, not recruiting |
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1060 | |
ARG026 | Recruiting |
Recoleta, Ciudad Autónoma De BuenosAires, Argentina, C1425EFD | |
ARG023 | Recruiting |
Río Cuarto, Córdoba, Argentina, 5800 | |
ARG014 | Completed |
Vistalba, Mendoza, Argentina, M5544 | |
ARG010 | Active, not recruiting |
Rosario, Santa Fe, Argentina, S2000DTC | |
ARG015 | Active, not recruiting |
San Miguel de Tucumán, Tucumán, Argentina, 4000 | |
ARG025 | Recruiting |
San Miguel de Tucumán, Tucumán, Argentina, T4000IHE | |
ARG005 | Active, not recruiting |
Córdoba, Argentina, X5003DCE | |
ARG007 | Active, not recruiting |
Mendoza, Argentina, M5500CCG | |
ARG011 | Active, not recruiting |
Rosario, Argentina, S2000JKR | |
ARG019 | Recruiting |
Santa Fe, Argentina, 3000 | |
Australia, New South Wales | |
AUS013 | Active, not recruiting |
Kogarah, New South Wales, Australia, 2217 | |
AUS008 | Active, not recruiting |
New Lambton Heights, New South Wales, Australia, 2305 | |
AUS007 | Active, not recruiting |
Westmead, New South Wales, Australia, 2145 | |
Australia, Queensland | |
AUS012 | Active, not recruiting |
Cairns North, Queensland, Australia, 4870 | |
AUS001 | Active, not recruiting |
Chermside, Queensland, Australia, 4032 | |
AUS010 | Active, not recruiting |
Greenslopes, Queensland, Australia, 4120 | |
AUS006 | Active, not recruiting |
South Brisbane, Queensland, Australia, 4101 | |
AUS019 | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Australia, South Australia | |
AUS011 | Active, not recruiting |
Adelaide, South Australia, Australia, 5000 | |
AUS017 | Active, not recruiting |
Bedford Park, South Australia, Australia, 5042 | |
AUS022 | Recruiting |
North Adelaide, South Australia, Australia, 5006 | |
AUS009 | Completed |
Woodville South, South Australia, Australia, 5011 | |
Australia, Victoria | |
AUS002 | Active, not recruiting |
Box Hill, Victoria, Australia, 3128 | |
AUS014 | Active, not recruiting |
Clayton, Victoria, Australia, 3168 | |
AUS020 | Recruiting |
Parkville, Victoria, Australia, 3052 | |
Australia, Western Australia | |
AUS018 | Active, not recruiting |
Murdoch, Western Australia, Australia, 6150 | |
AUS005 | Active, not recruiting |
Nedlands, Western Australia, Australia, 6009 | |
AUS021 | Recruiting |
Nedlands, Western Australia, Australia, 6009 | |
Australia | |
AUS003 | Active, not recruiting |
Concord, Australia, NSW 2139 | |
AUS015 | Active, not recruiting |
Spearwood, Australia, 6163 | |
Austria | |
AUT002 | Active, not recruiting |
Linz, Austria, 4021 | |
Belgium | |
BEL002 | Active, not recruiting |
Gent, Oost-Vlaanderen, Belgium, 9000 | |
BEL009 | Recruiting |
Gent, Oost-Vlaanderen, Belgium, 9000 | |
BEL004 | Recruiting |
Roeselare, West-Vlaanderen, Belgium, 8800 | |
BEL001 | Recruiting |
Leuven, Belgium, 3000 | |
BEL007 | Recruiting |
Liège, Belgium, 4000 | |
BEL003 | Active, not recruiting |
Mechelen, Belgium, 2800 | |
BEL008 | Active, not recruiting |
Sint-Niklaas, Belgium, 9100 | |
Brazil | |
BRA009 | Active, not recruiting |
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120 | |
BRA005 | Active, not recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074 | |
BRA001 | Active, not recruiting |
Blumenau, Santa Catarina, Brazil, 89030-240 | |
BRA006 | Active, not recruiting |
Santo André, São Paulo, Brazil, 09090-790 | |
BRA003 | Active, not recruiting |
Botucatu, Brazil, 18618-686 | |
BRA004 | Active, not recruiting |
São Bernardo do Campo, Brazil, 09715-090 | |
BRA011 | Active, not recruiting |
São Paulo, Brazil, 05403-000 | |
Bulgaria | |
BGR011 | Completed |
Sofia, Sofia-Grad, Bulgaria, 1336 | |
BGR009 | Completed |
Sofia, Sofia-Grad, Bulgaria, 1510 | |
BGR002 | Completed |
Sofia, Sofia-Grad, Bulgaria, 1680 | |
BGR005 | Completed |
Blagoevgrad, Bulgaria, 2700 | |
BGR006 | Completed |
Gabrovo, Bulgaria, 5300 | |
BGR014 | Completed |
Kozloduy, Bulgaria, 3320 | |
BGR015 | Completed |
Lovech, Bulgaria, 5500 | |
BGR007 | Completed |
Montana, Bulgaria, 3400 | |
BGR018 | Completed |
Pazardzhik, Bulgaria, 4400 | |
BGR019 | Completed |
Pleven, Bulgaria, 5800 | |
BGR004 | Completed |
Plovdiv, Bulgaria, 4023 | |
BGR008 | Completed |
Ruse, Bulgaria, 7002 | |
BGR017 | Completed |
Sliven, Bulgaria, 8800 | |
BGR010 | Completed |
Sofia, Bulgaria, 1233 | |
BGR012 | Completed |
Veliko Tarnovo, Bulgaria, 5000 | |
BGR013 | Completed |
Vidin, Bulgaria, 3700 | |
BGR016 | Completed |
Vratsa, Bulgaria, 3000 | |
Canada, Ontario | |
CAN004 | Active, not recruiting |
Toronto, Ontario, Canada, M5T 3A9 | |
Canada, Quebec | |
CAN002 | Completed |
Montreal, Quebec, Canada, H2X 0A9 | |
Chile | |
CHL007 | Active, not recruiting |
Valdivia, Los Ríos, Chile, 5110683 | |
CHL005 | Active, not recruiting |
Curicó, Maule, Chile, 3440000 | |
CHL010 | Active, not recruiting |
Talca, Maule, Chile, 3465586 | |
CHL001 | Active, not recruiting |
Providencia, Región-MetropolitanadeSantiago, Chile, 7500000 | |
CHL002 | Active, not recruiting |
Providencia, Región-MetropolitanadeSantiago, Chile, 7500010 | |
CHL008 | Active, not recruiting |
Providencia, Región-MetropolitanadeSantiago, Chile, 7500587 | |
CHL004 | Active, not recruiting |
Quillota, Chile, 2260000 | |
Colombia | |
COL006 | Active, not recruiting |
Zipaquira, Cundinamarca, Colombia, 250252 | |
COL001 | Active, not recruiting |
Bogotá, Distrito Capital De Bogotá, Colombia, 111211 | |
COL005 | Active, not recruiting |
Floridablanca, Santander, Colombia, 681004 | |
COL003 | Active, not recruiting |
Cali, Valle Del Cauca, Colombia, 760026 | |
COL002 | Active, not recruiting |
Bogota DC, Colombia, 110131 | |
COL004 | Active, not recruiting |
Santiago de Cali, Colombia, 076001 | |
Denmark | |
DNK008 | Active, not recruiting |
Copenhagen O, Capital, Denmark, 2100 | |
DNK001 | Completed |
Hvidovre, Capital, Denmark, DK-2650 | |
DNK005 | Active, not recruiting |
Odense C, South Denmark, Denmark, 5000 | |
DNK006 | Active, not recruiting |
Vejle, South Denmark, Denmark, 7100 | |
DNK003 | Active, not recruiting |
Aalborg, Denmark, 9000 | |
DNK007 | Active, not recruiting |
Aarhus, Denmark, DK-8200 | |
DNK004 | Active, not recruiting |
Hellerup, Denmark, 2900 | |
DNK002 | Active, not recruiting |
Roskilde, Denmark, 4000 | |
France | |
FRA002 | Active, not recruiting |
Strasbourg, Bas-Rhin, France, 67091 | |
FRA005 | Active, not recruiting |
Montpellier, Hérault, France, 34295 | |
FRA004 | Active, not recruiting |
Amiens cedex 1, France, 80054 | |
FRA011 | Recruiting |
Creteil, France, 94010 | |
FRA003 | Active, not recruiting |
Nantes, France, 44093 | |
FRA009 | Active, not recruiting |
Nice, France, 6002 | |
FRA010 | Active, not recruiting |
Paris, France, 75014 | |
FRA006 | Active, not recruiting |
Toulouse, France, 31400 | |
Germany | |
DEU009 | Active, not recruiting |
Heidelberg, Baden-Württemberg, Germany, 69126 | |
DEU025 | Active, not recruiting |
München, Bayern, Germany, 80336 | |
DEU027 | Active, not recruiting |
Potsdam, Brandenburg, Germany, 14467 | |
DEU008 | Active, not recruiting |
Frankfurt am Main, Hessen, Germany, 60590 | |
DEU005 | Active, not recruiting |
Marburg, Hessen, Germany, 35037 | |
DEU031 | Recruiting |
Hannover, Niedersachsen, Germany, 30625 | |
DEU013 | Active, not recruiting |
Essen, Nordrhein-Westfalen, Germany, 45239 | |
DEU016 | Active, not recruiting |
Halle, Sachsen-Anhalt, Germany, 06120 | |
DEU003 | Active, not recruiting |
Leipzig, Sachsen, Germany, 04347 | |
DEU020 | Active, not recruiting |
Geesthacht, Schleswig-Holstein, Germany, 21502 | |
DEU002 | Completed |
Berlin, Germany, 10717 | |
DEU019 | Active, not recruiting |
Berlin, Germany, 10969 | |
DEU006 | Active, not recruiting |
Berlin, Germany, 13125 | |
DEU011 | Recruiting |
Berlin, Germany, 13353 | |
DEU014 | Active, not recruiting |
Dresden, Germany, 01307 | |
DEU021 | Active, not recruiting |
Frankfurt, Germany, 60389 | |
DEU015 | Active, not recruiting |
Hannover, Germany, 30625 | |
DEU023 | Active, not recruiting |
Mainz, Germany, 55128 | |
DEU029 | Recruiting |
Muenster, Germany, 48149 | |
Greece | |
GRC003 | Active, not recruiting |
Alexandroupoli, Evros, Greece, 681 00 | |
GRC007 | Active, not recruiting |
Herakleion, Greece, 71110 | |
GRC006 | Active, not recruiting |
Thessaloniki, Greece, 57010 | |
Hungary | |
HUN005 | Completed |
Tatabánya, Komárom-Esztergom, Hungary, 2800 | |
Ireland | |
IRL003 | Active, not recruiting |
Dublin, Ireland, 15 | |
IRL002 | Active, not recruiting |
Dublin, Ireland, Dublin 8 | |
IRL001 | Active, not recruiting |
Limerick, Ireland, V94 F858 | |
Israel | |
ISR001 | Active, not recruiting |
Ashkelon, Israel, 78278 | |
ISR010 | Recruiting |
Beer Sheva, Israel, 84101 | |
ISR008 | Recruiting |
Haifa, Israel, 34362 | |
ISR006 | Recruiting |
Jerusalem, Israel, 91031 | |
ISR002 | Active, not recruiting |
Jerusalem, Israel, 91120 | |
ISR009 | Active, not recruiting |
Kefar-Sava, Israel, 44281 | |
ISR011 | Active, not recruiting |
Petach Tikva, Israel, 49100 | |
ISR007 | Recruiting |
Ramat Gan, Israel, 52621 | |
ISR003 | Active, not recruiting |
Rehovot, Israel, 76100 | |
ISR004 | Active, not recruiting |
Zerifin, Israel, 70300 | |
Italy | |
ITA010 | Active, not recruiting |
Bologna, Emilia-Romagna, Italy, 40138 | |
ITA008 | Active, not recruiting |
Ferrara, Emilia-Romagna, Italy, 44124 | |
ITA002 | Active, not recruiting |
Reggio Emilia, Emilia-Romagna, Italy, 42100 | |
ITA006 | Active, not recruiting |
Milano, Lombardia, Italy, 20122 | |
ITA012 | Recruiting |
Milano, Lombardia, Italy, 20122 | |
ITA011 | Active, not recruiting |
Rozzano, Lombardia, Italy, 20089 | |
ITA004 | Active, not recruiting |
Siena, Toscana, Italy, 53100 | |
ITA003 | Active, not recruiting |
Milano, Italy, 20157 | |
ITA001 | Active, not recruiting |
Palermo, Italy, 90127 | |
ITA007 | Active, not recruiting |
Pavia, Italy, 27100 | |
ITA009 | Active, not recruiting |
Roma, Italy, 00168 | |
Japan | |
JPN029 | Active, not recruiting |
Toyoake, Aiti, Japan, 470-1192 | |
JPN031 | Active, not recruiting |
Toon-Shi, Ehime, Japan, 791-0203 | |
JPN027 | Active, not recruiting |
Fukuoka-Shi, Hukuoka, Japan, 815-0032 | |
JPN023 | Active, not recruiting |
Iizuka-Shi, Hukuoka, Japan, 820-0018 | |
JPN021 | Active, not recruiting |
Kitakyushu-Shi, Hukuoka, Japan, 802-0052 | |
JPN009 | Recruiting |
Kobe-City, Hyôgo, Japan, 650-0047 | |
JPN020 | Recruiting |
Kasama-Shi, Ibaraki, Japan, 309-1703 | |
JPN001 | Active, not recruiting |
Naka-gun, Ibaraki, Japan, 319-1113 | |
JPN022 | Active, not recruiting |
Takamatsu-Shi, Kagawa, Japan, 761-8073 | |
JPN028 | Active, not recruiting |
Yokohama-Shi Konan-Ku, Kanagawa, Japan, 234-0054 | |
JPN005 | Active, not recruiting |
Koshi shi, Kumamoto, Japan, 861-1196 | |
JPN008 | Active, not recruiting |
Matsusaka-shi, Mie, Japan, 515-8544 | |
JPN011 | Active, not recruiting |
Tsu, Mie, Japan, 514-1101 | |
JPN034 | Active, not recruiting |
Sendai-shi, Miyagi, Japan, 980-0873 | |
JPN024 | Recruiting |
Sendai-shi, Miyagi, Japan, 984-8560 | |
JPN013 | Active, not recruiting |
Nagasaki-Shi, Nagasaki, Japan, 852-8501 | |
JPN012 | Active, not recruiting |
Chuo-ku, Niigata, Japan, 951-8510 | |
JPN015 | Active, not recruiting |
Matsue, Simane, Japan, 690-8556 | |
JPN007 | Recruiting |
Kiyose, Tokyo, Japan, 204-8522 | |
JPN014 | Active, not recruiting |
Ota-Ku, Tokyo, Japan, 143-8541 | |
JPN006 | Active, not recruiting |
Shinagawa-ku, Tokyo, Japan, 140-8522 | |
JPN017 | Active, not recruiting |
Shinagawa-ku, Tokyo, Japan, 141-8625 | |
JPN002 | Active, not recruiting |
Shinjuku-ku, Tokyo, Japan, 160-8582 | |
JPN032 | Active, not recruiting |
Shinjuku-ku, Tokyo, Japan, 1628655 | |
JPN019 | Active, not recruiting |
Shimonoseki-Shi, Yamaguti, Japan, 750-0041 | |
JPN030 | Active, not recruiting |
Fukuoka-shi, Japan, 8408571 | |
JPN003 | Active, not recruiting |
Hamamatsu-Shi, Japan, 434-8511 | |
JPN004 | Active, not recruiting |
Kita Kyushu-shi, Japan, 807-8556 | |
JPN016 | Active, not recruiting |
Matsue-shi, Japan, 690-8504 | |
JPN010 | Active, not recruiting |
Meguro-ku, Japan, 152-0021 | |
JPN018 | Active, not recruiting |
Toyonaka-shi, Japan, 560-8552 | |
Korea, Republic of | |
KOR015 | Active, not recruiting |
Ansan-si, Gyeonggido, Korea, Republic of, 15355 | |
KOR008 | Completed |
Bucheon-si, Gyeonggido, Korea, Republic of, 14584 | |
KOR007 | Active, not recruiting |
Seongnam-si, Gyeonggido, Korea, Republic of, 13620 | |
KOR003 | Active, not recruiting |
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030 | |
KOR004 | Active, not recruiting |
Incheon, Korea, Republic of, 21431 | |
KOR012 | Active, not recruiting |
Seoul, Korea, Republic of, 02447 | |
KOR011 | Completed |
Seoul, Korea, Republic of, 02841 | |
KOR009 | Active, not recruiting |
Seoul, Korea, Republic of, 03312 | |
KOR013 | Active, not recruiting |
Seoul, Korea, Republic of, 03722 | |
KOR010 | Active, not recruiting |
Seoul, Korea, Republic of, 06273 | |
KOR005 | Active, not recruiting |
Seoul, Korea, Republic of, 06591 | |
Latvia | |
LVA002 | Active, not recruiting |
Daugavpils, Daugavpils Aprinkis, Latvia, LV-5401 | |
LVA005 | Active, not recruiting |
Jurmala, Latvia, LV-2015 | |
Malaysia | |
MYS004 | Active, not recruiting |
Kuantan, Pahang, Malaysia, 25100 | |
MYS002 | Active, not recruiting |
Bandar Puncak Alam, Selangor, Malaysia, 42300 | |
MYS001 | Active, not recruiting |
Kuala Lumpur, WilayahPersekutuan KualaLumpur, Malaysia, 50603 | |
MYS003 | Active, not recruiting |
Kota Bahru, Malaysia, 16150 | |
MYS005 | Active, not recruiting |
Kuala Lumpur, Malaysia, 50590 | |
Mexico | |
MEX007 | Active, not recruiting |
Guadalajara, Jalisco, Mexico, 44160 | |
MEX008 | Active, not recruiting |
Guadalajara, Jalisco, Mexico, 44160 | |
MEX005 | Active, not recruiting |
Guadalajara, Jalisco, Mexico, 44220 | |
MEX004 | Active, not recruiting |
Guadalajara, Jalisco, Mexico, 44700 | |
MEX003 | Active, not recruiting |
Monterrey, Nuevo León, Mexico, 64460 | |
MEX006 | Active, not recruiting |
Durango, Mexico, 34080 | |
MEX001 | Active, not recruiting |
Monterrey, Mexico, 64718 | |
MEX002 | Active, not recruiting |
Oaxaca, Mexico, 68000 | |
Netherlands | |
NLD003 | Active, not recruiting |
Arnhem, Gelderland, Netherlands, 6815 AD | |
NLD001 | Active, not recruiting |
Alkmaar, Noord-Holland, Netherlands, 1815 JD | |
NLD002 | Active, not recruiting |
Amsterdam, Noord-Holland, Netherlands, 1105 AZ | |
NLD006 | Active, not recruiting |
Rotterdam, Netherlands, 3015 GD | |
New Zealand | |
NZL006 | Active, not recruiting |
Otahuhu, Auckland, New Zealand, 1640 | |
NZL009 | Completed |
Hastings, Hawkes's Bay, New Zealand, 4122 | |
NZL005 | Active, not recruiting |
Christchurch, South Island, New Zealand, 8011 | |
NZL001 | Active, not recruiting |
Dunedin, South Island, New Zealand, 9001 | |
NZL002 | Completed |
Hamilton, Waikato, New Zealand, 3204 | |
NZL011 | Completed |
Paraparaumu, Wellington, New Zealand, 5032 | |
NZL003 | Active, not recruiting |
Auckland, New Zealand, 1051 | |
NZL008 | Active, not recruiting |
Auckland, New Zealand, 1051 | |
NZL007 | Active, not recruiting |
Tauranga, New Zealand, 3110 | |
NZL010 | Completed |
Wellington, New Zealand, 6021 | |
Peru | |
PER005 | Active, not recruiting |
Chancay, Peru, 15131 | |
PER001 | Active, not recruiting |
Lima, Peru, 15001 | |
PER003 | Active, not recruiting |
Lima, Peru, 15036 | |
PER002 | Active, not recruiting |
Lima, Peru, 15084 | |
PER006 | Active, not recruiting |
Piura, Peru, 20001 | |
Poland | |
POL012 | Completed |
Ostrowiec Swietokrzyski, Swietokrzyskie, Poland, 27-400 | |
POL005 | Completed |
Bialystok, Poland, 15-044 | |
POL006 | Completed |
Bielsko Biala, Poland, 43-300 | |
POL016 | Completed |
Katowice, Poland, 40-081 | |
POL015 | Completed |
Kielce, Poland, 25-751 | |
POL017 | Completed |
Krakow, Poland, 30-510 | |
POL018 | Completed |
Ksawerow, Poland, 95-054 | |
POL008 | Completed |
Rabka-Zdroj, Poland, 34-700 | |
POL011 | Completed |
Rzeszów, Poland, 35-051 | |
POL010 | Completed |
Siedlce, Poland, 08-110 | |
POL007 | Completed |
Sosnowiec, Poland, 41-208 | |
POL001 | Completed |
Sucha Beskidzka, Poland, 34-200 | |
POL014 | Completed |
Szczecin, Poland, 70-111 | |
POL009 | Completed |
Tarnow, Poland, 33-100 | |
Portugal | |
PRT005 | Completed |
Aveiro, Portugal, 3814-501 | |
PRT009 | Active, not recruiting |
Braga, Portugal, 4710-243 | |
PRT006 | Active, not recruiting |
Guarda, Portugal, 6300-858 | |
PRT002 | Active, not recruiting |
Guimaraes, Portugal, 4835-044 | |
PRT003 | Active, not recruiting |
Lisboa, Portugal, 1649-035 | |
Serbia | |
SRB001 | Completed |
Belgrade, Serbia, 11000 | |
SRB003 | Completed |
Belgrade, Serbia, 11000 | |
SRB007 | Completed |
Nis, Serbia, 18000 | |
SRB014 | Completed |
Sombor, Serbia, 25000 | |
SRB010 | Completed |
Uzice, Serbia, 31000 | |
Slovakia | |
SVK002 | Completed |
Bardejov, Slovakia, 085 01 | |
SVK003 | Completed |
Spisská Nová Ves, Slovakia, 052 01 | |
Spain | |
ESP009 | Active, not recruiting |
Santiago de Compostela, A Coruña, Spain, 15706 | |
ESP008 | Active, not recruiting |
Oviedo, Asturias, Spain, 33011 | |
ESP013 | Active, not recruiting |
Badalona, Barcelona, Spain, 08036 | |
ESP012 | Active, not recruiting |
Santander, Cantabria, Spain, 39008 | |
ESP015 | Active, not recruiting |
Pozuelo de Alarcon, Madrid, Spain, 28223 | |
ESP011 | Active, not recruiting |
Pamplona, Navarra, Spain, 31008 | |
ESP003 | Active, not recruiting |
Barcelona, Spain, 08035 | |
ESP016 | Active, not recruiting |
Barcelona, Spain, 8036 | |
ESP001 | Completed |
Girona, Spain, 17007 | |
ESP006 | Active, not recruiting |
L´Hospitalet de Llobregat, Spain, 08907 | |
ESP007 | Active, not recruiting |
Madrid, Spain, 28007 | |
ESP002 | Active, not recruiting |
Madrid, Spain | |
Taiwan | |
TWN003 | Active, not recruiting |
Kaohsiung City, Taiwan, 80756 | |
TWN002 | Completed |
Kaohsiung, Taiwan, 82544 | |
TWN001 | Active, not recruiting |
Kaohsiung, Taiwan, 833 | |
TWN005 | Active, not recruiting |
New Taipei City, Taiwan, 22060 | |
TWN006 | Completed |
Taipei City, Taiwan, 11490 | |
TWN007 | Active, not recruiting |
Taipei, Taiwan, 10002 | |
TWN004 | Completed |
Taipei, Taiwan, 11217 | |
Thailand | |
THA004 | Active, not recruiting |
Nakhonnayok, Nakhon Nayok, Thailand, 26120 | |
THA002 | Active, not recruiting |
Muang, Nonthaburi, Thailand, 11000 | |
THA003 | Active, not recruiting |
Khon Kaen, Thailand, 40002 | |
Turkey | |
TUR006 | Active, not recruiting |
Atakum, Samsun, Turkey, 55270 | |
TUR010 | Active, not recruiting |
Ankara, Turkey, 6010 | |
TUR011 | Active, not recruiting |
Ankara, Turkey, 6340 | |
TUR003 | Active, not recruiting |
Canakkale, Turkey, 17110 | |
TUR008 | Completed |
Izmir, Turkey, 35100 | |
TUR004 | Active, not recruiting |
Izmir, Turkey, 35110 | |
TUR009 | Active, not recruiting |
Kocaeli, Turkey, 41380 | |
TUR005 | Active, not recruiting |
Konya, Turkey, 42075 | |
TUR001 | Active, not recruiting |
Mersin, Turkey, 33079 | |
Ukraine | |
UKR001 | Completed |
Kharkiv, Kharkivs'ka Oblast, Ukraine, 61124 | |
UKR007 | Completed |
Kherson, Khersons'ka Oblast, Ukraine, 73003 | |
UKR005 | Completed |
Poltava, Poltavs'ka Oblast, Ukraine, 36010 | |
UKR012 | Completed |
Dnipro, Ukraine, 49102 | |
UKR009 | Completed |
Ivano-Frankivsk, Ukraine, 76018 | |
UKR008 | Completed |
Kyiv, Ukraine, 01033 | |
UKR004 | Completed |
Kyiv, Ukraine, 03038 | |
UKR003 | Completed |
Odesa, Ukraine, 65025 | |
UKR010 | Completed |
Vinnytsia, Ukraine, 21018 | |
United Kingdom | |
GBR001 | Active, not recruiting |
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE | |
GBR015 | Active, not recruiting |
Exeter, Devon, United Kingdom, EX2 5DW | |
GBR017 | Active, not recruiting |
Norwich, Norfolk, United Kingdom, NR4 7UY | |
GBR013 | Active, not recruiting |
Llandough, Penarth, Vale Of Glamorgan, The, United Kingdom, CF64 2XX | |
GBR016 | Active, not recruiting |
Bradford, Yorkshire, United Kingdom, BD9 6RJ | |
GBR006 | Active, not recruiting |
Birmingham, United Kingdom, B9 5SS | |
GBR002 | Active, not recruiting |
Chertsey, United Kingdom, KT16 0PZ | |
GBR007 | Active, not recruiting |
Dundee, United Kingdom, DDI 9SY | |
GBR004 | Active, not recruiting |
Liverpool, United Kingdom, L14 3PE | |
GBR009 | Active, not recruiting |
London, United Kingdom, SW3 6NP | |
GBR008 | Active, not recruiting |
Manchester, United Kingdom, M23 9LT | |
GBR011 | Active, not recruiting |
Manchester, United Kingdom, M8 5RB | |
GBR003 | Active, not recruiting |
Newcastle upon Tyne, United Kingdom, NE7 7DN | |
GBR012 | Active, not recruiting |
Salford, United Kingdom, M6 8HD | |
GBR018 | Active, not recruiting |
Southampton, United Kingdom, SO16 6YD | |
GBR010 | Active, not recruiting |
Swansea, United Kingdom, SA6 6NL |
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: | May 22, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ASPEN Brensocatib INS1007 |
Bronchiectasis Fibrosis Pathologic Processes Bronchial Diseases Respiratory Tract Diseases |