ASPEN: A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Sponsor
Insmed Incorporated (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04594369
Collaborator
(none)
1,620
424
3
39.7
3.8
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Dec 1, 2020
Anticipated Primary Completion Date
:
Mar 22, 2024
Anticipated Study Completion Date
:
Mar 22, 2024
Arms and Interventions
| 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 Names:
|
| Experimental: Brensocatib 25 mg Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks. |
Drug: Brensocatib 25 mg
Oral tablet.
Other Names:
|
| 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
Primary Outcome Measures
- Rate of Adjudicated Pulmonary Exacerbations (PEs) [52 Weeks]
Secondary Outcome Measures
- Time to First Adjudicated Pulmonary Exacerbation (PE) [52 Weeks]
- Percentage of Participants who are Pulmonary Exacerbation (PE) Free [52 Weeks]
- Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 second (FEV1) [Baseline, at Week 52]
- Rate of Severe Adjudicated Pulmonary Exacerbations (PEs) [52 Weeks]
- Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants [Baseline to Week 52]
- Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs) [56 Weeks]
- Plasma Concentration of Brensocatib at Select Time Points [Pre-dose and post-dose at multiple time points up to Week 52]
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Provide their signed study informed consent to participate.
- 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.
- 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 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | USA013 | Birmingham | Alabama | United States | 35233-1711 |
| 2 | USA080 | Conway | Arkansas | United States | 72032 |
| 3 | USA044 | Little Rock | Arkansas | United States | 72205 |
| 4 | USA104 | Fresno | California | United States | 93702 |
| 5 | USA086 | Los Angeles | California | United States | 90033 |
| 6 | USA055 | Los Angeles | California | United States | 90048 |
| 7 | USA029 | Newport Beach | California | United States | 92663 |
| 8 | USA102 | Northridge | California | United States | 91324-3138 |
| 9 | USA022 | Palm Springs | California | United States | 92262 |
| 10 | USA024 | Sacramento | California | United States | 95817-1460 |
| 11 | USA057 | San Diego | California | United States | 92103 |
| 12 | USA035 | San Diego | California | United States | 92120 |
| 13 | USA078 | Santa Barbara | California | United States | 93105-4353 |
| 14 | USA027 | Ventura | California | United States | 93003 |
| 15 | USA075 | Denver | Colorado | United States | 80206-2761 |
| 16 | USA008 | Lafayette | Colorado | United States | 80026 |
| 17 | USA017 | Farmington | Connecticut | United States | 06030 |
| 18 | USA001 | Washington | District of Columbia | United States | 20007 |
| 19 | USA015 | Clearwater | Florida | United States | 33765 |
| 20 | USA076 | Gainesville | Florida | United States | 32610-0001 |
| 21 | USA032 | Jacksonville | Florida | United States | 32204-4736 |
| 22 | USA082 | Jacksonville | Florida | United States | 32224-1865 |
| 23 | USA039 | Kissimmee | Florida | United States | 34746 |
| 24 | USA072 | Leesburg | Florida | United States | 34748-5077 |
| 25 | USA019 | Miami Lakes | Florida | United States | 33014 |
| 26 | USA037 | Miami | Florida | United States | 33126 |
| 27 | USA049 | Naples | Florida | United States | 34102-5444 |
| 28 | USA106 | New Port Richey | Florida | United States | 34652-3903 |
| 29 | USA108 | Orlando | Florida | United States | 32803-5443 |
| 30 | USA052 | Orlando | Florida | United States | 32825 |
| 31 | USA103 | Plantation | Florida | United States | 33324 |
| 32 | USA089 | Saint Petersburg | Florida | United States | 33704 |
| 33 | USA074 | Saint Petersburg | Florida | United States | 33707 |
| 34 | USA084 | Sarasota | Florida | United States | 34239-2913 |
| 35 | USA113 | Sebring | Florida | United States | 33870-1216 |
| 36 | USA012 | Atlanta | Georgia | United States | 30342 |
| 37 | USA053 | Augusta | Georgia | United States | 30912 |
| 38 | USA077 | Rincon | Georgia | United States | 31326 |
| 39 | USA073 | Chicago | Illinois | United States | 60611-2951 |
| 40 | USA061 | Maywood | Illinois | United States | 60153 |
| 41 | USA115 | Munster | Indiana | United States | 46321-4054 |
| 42 | USA063 | Iowa City | Iowa | United States | 52242 |
| 43 | USA031 | Kansas City | Kansas | United States | 66160 |
| 44 | USA020 | New Orleans | Louisiana | United States | 70112 |
| 45 | USA051 | New Orleans | Louisiana | United States | 70112 |
| 46 | USA003 | Baltimore | Maryland | United States | 21224-3057 |
| 47 | USA079 | Boston | Massachusetts | United States | 02114 |
| 48 | USA064 | Springfield | Massachusetts | United States | 01199 |
| 49 | USA010 | Rochester | Minnesota | United States | 55905 |
| 50 | USA006 | Chesterfield | Missouri | United States | 63017 |
| 51 | USA059 | Saint Louis | Missouri | United States | 63110 |
| 52 | USA110 | Lincoln | Nebraska | United States | 68510 |
| 53 | USA105 | Hackensack | New Jersey | United States | 07601-1915 |
| 54 | USA065 | Toms River | New Jersey | United States | 08755 |
| 55 | USA095 | Bronx | New York | United States | 10461 |
| 56 | USA066 | New Hyde Park | New York | United States | 11042-1102 |
| 57 | USA021 | New York | New York | United States | 10016 |
| 58 | USA085 | New York | New York | United States | 10032-3729 |
| 59 | USA068 | Potsdam | New York | United States | 13676 |
| 60 | USA112 | Charlotte | North Carolina | United States | 28277 |
| 61 | USA033 | Gastonia | North Carolina | United States | 28054 |
| 62 | USA096 | Huntersville | North Carolina | United States | 28078-5082 |
| 63 | USA026 | Winston-Salem | North Carolina | United States | 27103 |
| 64 | USA067 | Cincinnati | Ohio | United States | 45267 |
| 65 | USA028 | Cleveland | Ohio | United States | 44106 |
| 66 | USA093 | Cleveland | Ohio | United States | 44195 |
| 67 | USA023 | Portland | Oregon | United States | 97239 |
| 68 | USA038 | DuBois | Pennsylvania | United States | 15801 |
| 69 | USA046 | Philadelphia | Pennsylvania | United States | 19104 |
| 70 | USA071 | Anderson | South Carolina | United States | 29621 |
| 71 | USA005 | Charleston | South Carolina | United States | 29425 |
| 72 | USA036 | Rock Hill | South Carolina | United States | 29732 |
| 73 | USA041 | Franklin | Tennessee | United States | 37067 |
| 74 | USA097 | Dallas | Texas | United States | 75246-2081 |
| 75 | USA087 | Galveston | Texas | United States | 77555-5302 |
| 76 | USA050 | McKinney | Texas | United States | 75069 |
| 77 | USA018 | Mesquite | Texas | United States | 75149 |
| 78 | USA011 | San Antonio | Texas | United States | 78258 |
| 79 | USA002 | Tyler | Texas | United States | 75708 |
| 80 | USA081 | Salt Lake City | Utah | United States | 84102-1892 |
| 81 | USA034 | Williamsburg | Virginia | United States | 23188 |
| 82 | USA088 | Vancouver | Washington | United States | 98664-1913 |
| 83 | ARG021 | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1121ABE |
| 84 | ARG022 | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1122AAK |
| 85 | ARG002 | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1414AIF |
| 86 | ARG001 | Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | C1425AZB |
| 87 | ARG003 | Ciudad Autónoma de BuenosAires | Buenos Aires | Argentina | C1425BEN |
| 88 | ARG004 | Ciudad Autónoma de BuenosAires | Buenos Aires | Argentina | C1426ABP |
| 89 | ARG006 | la Plata | Buenos Aires | Argentina | B1902COS |
| 90 | ARG013 | Mar del Plata | Buenos Aires | Argentina | B7600FYK |
| 91 | ARG017 | Mar Del Plata | Buenos Aires | Argentina | CP 7600 |
| 92 | ARG009 | Villa Vatteone | Buenos Aires | Argentina | B1853AIK |
| 93 | ARG012 | Ciudad Autónoma de Buenos Aires | Ciudad Autónoma De BuenosAires | Argentina | C10227AAP |
| 94 | ARG018 | Ciudad Autónoma de Buenos Aires | Ciudad Autónoma De BuenosAires | Argentina | C1060 |
| 95 | ARG014 | Vistalba | Mendoza | Argentina | M5544 |
| 96 | ARG010 | Rosario | Santa Fe | Argentina | S2000DTC |
| 97 | ARG015 | San Miguel de Tucumán | Tucumán | Argentina | 4000 |
| 98 | ARG008 | San Miguel de Tucumán | Tucumán | Argentina | T4000IAR |
| 99 | ARG005 | Córdoba | Argentina | X5003DCE | |
| 100 | ARG007 | Mendoza | Argentina | M5500CCG | |
| 101 | ARG011 | Rosario | Argentina | S2000JKR | |
| 102 | ARG019 | Santa Fe | Argentina | 3000 | |
| 103 | AUS013 | Kogarah | New South Wales | Australia | 2217 |
| 104 | AUS008 | New Lambton Heights | New South Wales | Australia | 2305 |
| 105 | AUS007 | Westmead | New South Wales | Australia | 2145 |
| 106 | AUS012 | Cairns North | Queensland | Australia | 4870 |
| 107 | AUS001 | Chermside | Queensland | Australia | 4032 |
| 108 | AUS010 | Greenslopes | Queensland | Australia | 4120 |
| 109 | AUS006 | South Brisbane | Queensland | Australia | 4101 |
| 110 | AUS019 | South Brisbane | Queensland | Australia | 4101 |
| 111 | AUS011 | Adelaide | South Australia | Australia | 5000 |
| 112 | AUS017 | Bedford Park | South Australia | Australia | 5042 |
| 113 | AUS004 | Kent Town | South Australia | Australia | 5067 |
| 114 | AUS022 | North Adelaide | South Australia | Australia | 5006 |
| 115 | AUS009 | Woodville South | South Australia | Australia | 5011 |
| 116 | AUS002 | Box Hill | Victoria | Australia | 3128 |
| 117 | AUS014 | Clayton | Victoria | Australia | 3168 |
| 118 | AUS020 | Parkville | Victoria | Australia | 3052 |
| 119 | AUS018 | Murdoch | Western Australia | Australia | 6150 |
| 120 | AUS005 | Nedlands | Western Australia | Australia | 6009 |
| 121 | AUS021 | Nedlands | Western Australia | Australia | 6009 |
| 122 | AUS003 | Concord | Australia | NSW 2139 | |
| 123 | AUS015 | Spearwood | Australia | 6163 | |
| 124 | AUT001 | Graz | Steiermark | Austria | 8036 |
| 125 | AUT002 | Linz | Austria | 4021 | |
| 126 | BEL002 | Gent | Oost-Vlaanderen | Belgium | 9000 |
| 127 | BEL004 | Roeselare | West-Vlaanderen | Belgium | 8800 |
| 128 | BEL006 | Brussels | Belgium | 1000 | |
| 129 | BEL005 | Edegem | Belgium | 2650 | |
| 130 | BEL001 | Leuven | Belgium | 3000 | |
| 131 | BEL007 | Liège | Belgium | 4000 | |
| 132 | BEL003 | Mechelen | Belgium | 2800 | |
| 133 | BEL008 | Sint-Niklaas | Belgium | 9100 | |
| 134 | BRA009 | Passo Fundo | Rio Grande Do Sul | Brazil | 99010-120 |
| 135 | BRA005 | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-074 |
| 136 | BRA001 | Blumenau | Santa Catarina | Brazil | 89030-240 |
| 137 | BRA002 | Santo André | São Paulo | Brazil | 09060-650 |
| 138 | BRA006 | Santo André | São Paulo | Brazil | 09090-790 |
| 139 | BRA003 | Botucatu | Brazil | 18618-686 | |
| 140 | BRA004 | São Bernardo do Campo | Brazil | 09715-090 | |
| 141 | BRA010 | São Paulo | Brazil | 01327-001 | |
| 142 | BGR011 | Sofia | Sofia-Grad | Bulgaria | 1336 |
| 143 | BGR009 | Sofia | Sofia-Grad | Bulgaria | 1510 |
| 144 | BGR002 | Sofia | Sofia-Grad | Bulgaria | 1680 |
| 145 | BGR005 | Blagoevgrad | Bulgaria | 2700 | |
| 146 | BGR006 | Gabrovo | Bulgaria | 5300 | |
| 147 | BGR014 | Kozloduy | Bulgaria | 3320 | |
| 148 | BGR015 | Lovech | Bulgaria | 5500 | |
| 149 | BGR007 | Montana | Bulgaria | 3400 | |
| 150 | BGR018 | Pazardzhik | Bulgaria | 4400 | |
| 151 | BGR019 | Pleven | Bulgaria | 5800 | |
| 152 | BGR004 | Plovdiv | Bulgaria | 4023 | |
| 153 | BGR008 | Ruse | Bulgaria | 7002 | |
| 154 | BGR017 | Sliven | Bulgaria | 8800 | |
| 155 | BGR010 | Sofia | Bulgaria | 1233 | |
| 156 | BGR012 | Veliko Tarnovo | Bulgaria | 5000 | |
| 157 | BGR013 | Vidin | Bulgaria | 3700 | |
| 158 | BGR016 | Vratsa | Bulgaria | 3000 | |
| 159 | CAN004 | Toronto | Ontario | Canada | M5T 3A9 |
| 160 | CAN002 | Montreal | Quebec | Canada | H2X 0A9 |
| 161 | CAN003 | Saint-Charles-Borromée | Quebec | Canada | J6E 2B4 |
| 162 | CHL007 | Valdivia | Los Ríos | Chile | 5110683 |
| 163 | CHL005 | Curicó | Maule | Chile | 3440000 |
| 164 | CHL010 | Talca | Maule | Chile | 3465586 |
| 165 | CHL001 | Providencia | Región-MetropolitanadeSantiago | Chile | 7500000 |
| 166 | CHL002 | Providencia | Región-MetropolitanadeSantiago | Chile | 7500010 |
| 167 | CHL008 | Providencia | Región-MetropolitanadeSantiago | Chile | 7500587 |
| 168 | CHL004 | Quillota | Chile | 2260000 | |
| 169 | COL007 | Medellín | Antioquia | Colombia | 050012 |
| 170 | COL006 | Zipaquira | Cundinamarca | Colombia | 250252 |
| 171 | COL001 | Bogotá | Distrito Capital De Bogotá | Colombia | 111211 |
| 172 | COL005 | Floridablanca | Santander | Colombia | 681004 |
| 173 | COL003 | Cali | Valle Del Cauca | Colombia | 760026 |
| 174 | COL004 | Cali | Colombia | 760042 | |
| 175 | DNK008 | Copenhagen O | Capital | Denmark | 2100 |
| 176 | DNK001 | Hvidovre | Capital | Denmark | DK-2650 |
| 177 | DNK005 | Odense C | South Denmark | Denmark | 5000 |
| 178 | DNK006 | Vejle | South Denmark | Denmark | 7100 |
| 179 | DNK003 | Aalborg | Denmark | 9000 | |
| 180 | DNK007 | Aarhus | Denmark | DK-8200 | |
| 181 | DNK004 | Hellerup | Denmark | 2900 | |
| 182 | DNK002 | Roskilde | Denmark | 4000 | |
| 183 | FRA002 | Strasbourg | Bas-Rhin | France | 67091 |
| 184 | FRA005 | Montpellier | Hérault | France | 34295 |
| 185 | FRA001 | Tours | Indre-et-Loire | France | 37044 |
| 186 | FRA004 | Amiens cedex 1 | France | 80054 | |
| 187 | FRA011 | Creteil | France | 94010 | |
| 188 | FRA003 | Nantes | France | 44093 | |
| 189 | FRA009 | Nice | France | 6002 | |
| 190 | FRA010 | Paris | France | 75014 | |
| 191 | FRA008 | Saint-Pierre | France | 97448 | |
| 192 | FRA006 | Toulouse | France | 31400 | |
| 193 | DEU009 | Heidelberg | Baden-Württemberg | Germany | 69126 |
| 194 | DEU001 | Donaustauf | Bayern | Germany | 93093 |
| 195 | DEU025 | München | Bayern | Germany | 80336 |
| 196 | DEU012 | München | Bayern | Germany | 81925 |
| 197 | DEU027 | Potsdam | Brandenburg | Germany | 14467 |
| 198 | DEU008 | Frankfurt | Hessen | Germany | 60590 |
| 199 | DEU005 | Marburg | Hessen | Germany | 35037 |
| 200 | DEU026 | Marburg | Hessen | Germany | 35043 |
| 201 | DEU018 | Neu-Isenburg | Hessen | Germany | 63263 |
| 202 | DEU010 | Borstel | Niedersachsen | Germany | 23845 |
| 203 | DEU030 | Bochum | Nordrhein-Westfalen | Germany | 44791 |
| 204 | DEU013 | Essen | Nordrhein-Westfalen | Germany | 45239 |
| 205 | DEU024 | Homburg | Saarland | Germany | 66424 |
| 206 | DEU016 | Halle | Sachsen-Anhalt | Germany | 06120 |
| 207 | DEU003 | Leipzig | Sachsen | Germany | 04347 |
| 208 | DEU020 | Geesthacht | Schleswig-Holstein | Germany | 21502 |
| 209 | DEU007 | Lübeck | Schleswig-Holstein | Germany | 23552 |
| 210 | DEU028 | Berlin | Germany | 10117 | |
| 211 | DEU002 | Berlin | Germany | 10717 | |
| 212 | DEU019 | Berlin | Germany | 10969 | |
| 213 | DEU006 | Berlin | Germany | 13125 | |
| 214 | DEU011 | Berlin | Germany | 13353 | |
| 215 | DEU014 | Dresden | Germany | 01307 | |
| 216 | DEU021 | Frankfurt | Germany | 60389 | |
| 217 | DEU022 | Hannover | Germany | 30173 | |
| 218 | DEU015 | Hannover | Germany | 30625 | |
| 219 | DEU023 | Mainz | Germany | 55128 | |
| 220 | DEU029 | Muenster | Germany | 48149 | |
| 221 | GRC003 | Alexandroupoli | Evros | Greece | 681 00 |
| 222 | GRC002 | Larissa | Larisa | Greece | 41110 |
| 223 | GRC007 | Herakleion | Greece | 71110 | |
| 224 | GRC006 | Thessaloniki | Greece | 57010 | |
| 225 | HUN005 | Tatabánya | Komárom-Esztergom | Hungary | 2800 |
| 226 | IRL003 | Dublin | Ireland | 15 | |
| 227 | IRL004 | Dublin | Ireland | D24 NR0A | |
| 228 | IRL002 | Dublin | Ireland | Dublin 8 | |
| 229 | IRL001 | Limerick | Ireland | V94 F858 | |
| 230 | ISR001 | Ashkelon | Israel | 78278 | |
| 231 | ISR010 | Beer Sheva | Israel | 84101 | |
| 232 | ISR008 | Haifa | Israel | 34362 | |
| 233 | ISR006 | Jerusalem | Israel | 91031 | |
| 234 | ISR002 | Jerusalem | Israel | 91120 | |
| 235 | ISR009 | Kefar-Sava | Israel | 44281 | |
| 236 | ISR011 | Petach Tikva | Israel | 49100 | |
| 237 | ISR007 | Ramat Gan | Israel | 52621 | |
| 238 | ISR003 | Rehovot | Israel | 76100 | |
| 239 | ISR004 | Zerifin | Israel | 70300 | |
| 240 | ITA010 | Bologna | Emilia-Romagna | Italy | 40138 |
| 241 | ITA008 | Ferrara | Emilia-Romagna | Italy | 44124 |
| 242 | ITA002 | Reggio Emilia | Emilia-Romagna | Italy | 42100 |
| 243 | ITA006 | Milano | Lombardia | Italy | 20122 |
| 244 | ITA011 | Rozzano | Lombardia | Italy | 20089 |
| 245 | ITA004 | Siena | Toscana | Italy | 53100 |
| 246 | ITA003 | Milano | Italy | 20157 | |
| 247 | ITA001 | Palermo | Italy | 90127 | |
| 248 | ITA007 | Pavia | Italy | 27100 | |
| 249 | ITA009 | Roma | Italy | 00168 | |
| 250 | JPN029 | Toyoake | Aiti | Japan | 470-1192 |
| 251 | JPN026 | Akita-Shi | Akita | Japan | 010-8543 |
| 252 | JPN031 | Toon-Shi | Ehime | Japan | 791-0203 |
| 253 | JPN027 | Fukuoka-Shi | Hukuoka | Japan | 815-0032 |
| 254 | JPN023 | Iizuka-Shi | Hukuoka | Japan | 820-0018 |
| 255 | JPN021 | Kitakyushu-Shi | Hukuoka | Japan | 802-0052 |
| 256 | JPN025 | Yanagawa-Shi | Hukuoka | Japan | 832-0059 |
| 257 | JPN009 | Kobe-City | Hyôgo | Japan | 650-0047 |
| 258 | JPN020 | Kasama-Shi | Ibaraki | Japan | 309-1703 |
| 259 | JPN001 | Naka-gun | Ibaraki | Japan | 319-1113 |
| 260 | JPN022 | Takamatsu-Shi | Kagawa | Japan | 761-8073 |
| 261 | JPN028 | Yokohama-Shi Konan-Ku | Kanagawa | Japan | 234-0054 |
| 262 | JPN005 | Koshi shi | Kumamoto | Japan | 861-1196 |
| 263 | JPN008 | Matsusaka-shi | Mie | Japan | 515-8544 |
| 264 | JPN011 | Tsu | Mie | Japan | 514-1101 |
| 265 | JPN034 | Sendai-shi | Miyagi | Japan | 980-0873 |
| 266 | JPN024 | Sendai-shi | Miyagi | Japan | 984-8560 |
| 267 | JPN013 | Nagasaki-Shi | Nagasaki | Japan | 852-8501 |
| 268 | JPN012 | Chuo-ku | Niigata | Japan | 951-8510 |
| 269 | JPN015 | Matsue | Simane | Japan | 690-8556 |
| 270 | JPN007 | Kiyose | Tokyo | Japan | 204-8522 |
| 271 | JPN014 | Ota-Ku | Tokyo | Japan | 143-8541 |
| 272 | JPN006 | Shinagawa-ku | Tokyo | Japan | 140-8522 |
| 273 | JPN017 | Shinagawa-ku | Tokyo | Japan | 141-8625 |
| 274 | JPN002 | Shinjuku-ku | Tokyo | Japan | 160-8582 |
| 275 | JPN032 | Shinjuku-ku | Tokyo | Japan | 1628655 |
| 276 | JPN019 | Shimonoseki-Shi | Yamaguti | Japan | 750-0041 |
| 277 | JPN030 | Fukuoka-shi | Japan | 8408571 | |
| 278 | JPN003 | Hamamatsu-Shi | Japan | 434-8511 | |
| 279 | JPN004 | Kita Kyushu-shi | Japan | 807-8556 | |
| 280 | JPN016 | Matsue-shi | Japan | 690-8504 | |
| 281 | JPN010 | Meguro-ku | Japan | 152-0021 | |
| 282 | JPN033 | Sakai-shi | Japan | 591-8555 | |
| 283 | JPN018 | Toyonaka-shi | Japan | 560-8552 | |
| 284 | KOR015 | Ansan-si | Gyeonggido | Korea, Republic of | 15355 |
| 285 | KOR008 | Bucheon-si | Gyeonggido | Korea, Republic of | 14584 |
| 286 | KOR007 | Seongnam-si | Gyeonggido | Korea, Republic of | 13620 |
| 287 | KOR014 | Uijeongbu-Si | Gyeonggido | Korea, Republic of | 11765 |
| 288 | KOR003 | Seoul | Seoul Teugbyeolsi | Korea, Republic of | 05030 |
| 289 | KOR004 | Incheon | Korea, Republic of | 21431 | |
| 290 | KOR001 | Incheon | Korea, Republic of | 21565 | |
| 291 | KOR002 | Incheon | Korea, Republic of | 22332 | |
| 292 | KOR012 | Seoul | Korea, Republic of | 02447 | |
| 293 | KOR011 | Seoul | Korea, Republic of | 02841 | |
| 294 | KOR006 | Seoul | Korea, Republic of | 03080 | |
| 295 | KOR009 | Seoul | Korea, Republic of | 03312 | |
| 296 | KOR013 | Seoul | Korea, Republic of | 03722 | |
| 297 | KOR010 | Seoul | Korea, Republic of | 06273 | |
| 298 | KOR005 | Seoul | Korea, Republic of | 06591 | |
| 299 | LVA002 | Daugavpils | Daugavpils Aprinkis | Latvia | LV-5401 |
| 300 | LVA005 | Jurmala | Latvia | LV-2015 | |
| 301 | MYS004 | Kuantan | Pahang | Malaysia | 25100 |
| 302 | MYS006 | Kuching | Sarawak | Malaysia | 93586 |
| 303 | MYS002 | Bandar Puncak Alam | Selangor | Malaysia | 42300 |
| 304 | MYS001 | Kuala Lumpur | WilayahPersekutuan KualaLumpur | Malaysia | 50603 |
| 305 | MYS003 | Kota Bahru | Malaysia | 16150 | |
| 306 | MYS005 | Kuala Lumpur | Malaysia | 50590 | |
| 307 | MEX007 | Guadalajara | Jalisco | Mexico | 44160 |
| 308 | MEX008 | Guadalajara | Jalisco | Mexico | 44160 |
| 309 | MEX005 | Guadalajara | Jalisco | Mexico | 44220 |
| 310 | MEX004 | Guadalajara | Jalisco | Mexico | 44700 |
| 311 | MEX003 | Monterrey | Nuevo León | Mexico | 64460 |
| 312 | MEX006 | Durango | Mexico | 34080 | |
| 313 | MEX001 | Monterrey | Mexico | 64718 | |
| 314 | MEX002 | Oaxaca | Mexico | 68000 | |
| 315 | NLD003 | Arnhem | Gelderland | Netherlands | 6815 AD |
| 316 | NLD001 | Alkmaar | Noord-Holland | Netherlands | 1815 JD |
| 317 | NLD002 | Amsterdam | Noord-Holland | Netherlands | 1105 AZ |
| 318 | NLD004 | Den Haag | Zuid-Holland | Netherlands | 2545 AA |
| 319 | NLD005 | Heerlen | Netherlands | 6419PC | |
| 320 | NLD006 | Rotterdam | Netherlands | 3015 GD | |
| 321 | NZL006 | Otahuhu | Auckland | New Zealand | 1640 |
| 322 | NZL005 | Christchurch | South Island | New Zealand | 8011 |
| 323 | NZL001 | Dunedin | South Island | New Zealand | 9001 |
| 324 | NZL002 | Hamilton | Waikato | New Zealand | 3204 |
| 325 | NZL011 | Paraparaumu | Wellington | New Zealand | 5032 |
| 326 | NZL003 | Auckland | New Zealand | 1051 | |
| 327 | NZL008 | Auckland | New Zealand | 1051 | |
| 328 | NZL009 | Havelock North | New Zealand | 4130 | |
| 329 | NZL007 | Tauranga | New Zealand | 3110 | |
| 330 | NZL010 | Wellington | New Zealand | 6021 | |
| 331 | PER008 | La Victoria | Lima | Peru | 15004 |
| 332 | PER005 | Chancay | Peru | 15131 | |
| 333 | PER001 | Lima | Peru | 15001 | |
| 334 | PER003 | Lima | Peru | 15036 | |
| 335 | PER002 | Lima | Peru | 15084 | |
| 336 | PER006 | Piura | Peru | 20001 | |
| 337 | PER004 | San Miguel | Peru | 15088 | |
| 338 | POL012 | Ostrowiec Swietokrzyski | Swietokrzyskie | Poland | 27-400 |
| 339 | POL005 | Bialystok | Poland | 15-044 | |
| 340 | POL006 | Bielsko Biala | Poland | 43-300 | |
| 341 | POL016 | Katowice | Poland | 40-081 | |
| 342 | POL015 | Kielce | Poland | 25-751 | |
| 343 | POL017 | Krakow | Poland | 30-510 | |
| 344 | POL018 | Ksawerow | Poland | 95-054 | |
| 345 | POL008 | Rabka-Zdroj | Poland | 34-700 | |
| 346 | POL011 | Rzeszów | Poland | 35-051 | |
| 347 | POL010 | Siedlce | Poland | 08-110 | |
| 348 | POL007 | Sosnowiec | Poland | 41-208 | |
| 349 | POL001 | Sucha Beskidzka | Poland | 34-200 | |
| 350 | POL014 | Szczecin | Poland | 70-111 | |
| 351 | POL009 | Tarnow | Poland | 33-100 | |
| 352 | PRT004 | Loures | Lisboa | Portugal | 2674-514 |
| 353 | PRT005 | Aveiro | Portugal | 3814-501 | |
| 354 | PRT009 | Braga | Portugal | 4710-243 | |
| 355 | PRT001 | Covilhã | Portugal | 6200-251 | |
| 356 | PRT006 | Guarda | Portugal | 6300-858 | |
| 357 | PRT002 | Guimaraes | Portugal | 4835-044 | |
| 358 | PRT003 | Lisboa | Portugal | 1649-035 | |
| 359 | PRT007 | Vila Nova de Gaia | Portugal | 4434-502 | |
| 360 | SRB001 | Belgrade | Serbia | 11000 | |
| 361 | SRB003 | Belgrade | Serbia | 11000 | |
| 362 | SRB007 | Nis | Serbia | 18000 | |
| 363 | SRB014 | Sombor | Serbia | 25000 | |
| 364 | SRB010 | Uzice | Serbia | 31000 | |
| 365 | SVK002 | Bardejov | Slovakia | 085 01 | |
| 366 | SVK003 | Spisská Nová Ves | Slovakia | 052 01 | |
| 367 | ESP009 | Santiago de Compostela | A Coruña | Spain | 15706 |
| 368 | ESP008 | Oviedo | Asturias | Spain | 33011 |
| 369 | ESP013 | Badalona | Barcelona | Spain | 08036 |
| 370 | ESP012 | Santander | Cantabria | Spain | 39008 |
| 371 | ESP015 | Pozuelo de Alarcon | Madrid | Spain | 28223 |
| 372 | ESP011 | Pamplona | Navarra | Spain | 31008 |
| 373 | ESP003 | Barcelona | Spain | 08035 | |
| 374 | ESP016 | Barcelona | Spain | 8036 | |
| 375 | ESP001 | Girona | Spain | 17007 | |
| 376 | ESP006 | L´Hospitalet de Llobregat | Spain | 08907 | |
| 377 | ESP007 | Madrid | Spain | 28007 | |
| 378 | ESP002 | Madrid | Spain | ||
| 379 | TWN003 | Kaohsiung City | Taiwan | 80756 | |
| 380 | TWN002 | Kaohsiung | Taiwan | 82544 | |
| 381 | TWN001 | Kaohsiung | Taiwan | 833 | |
| 382 | TWN005 | New Taipei City | Taiwan | 22060 | |
| 383 | TWN006 | Taipei City | Taiwan | 11490 | |
| 384 | TWN007 | Taipei | Taiwan | 10002 | |
| 385 | TWN004 | Taipei | Taiwan | 11217 | |
| 386 | THA004 | Nakhonnayok | Nakhon Nayok | Thailand | 26120 |
| 387 | THA002 | Muang | Nonthaburi | Thailand | 11000 |
| 388 | THA001 | Bangkok | Thailand | 10400 | |
| 389 | THA003 | Khon Kaen | Thailand | 40002 | |
| 390 | TUR006 | Atakum | Samsun | Turkey | 55270 |
| 391 | TUR010 | Ankara | Turkey | 6010 | |
| 392 | TUR011 | Ankara | Turkey | 6340 | |
| 393 | TUR003 | Canakkale | Turkey | 17110 | |
| 394 | TUR008 | Izmir | Turkey | 35100 | |
| 395 | TUR004 | Izmir | Turkey | 35110 | |
| 396 | TUR009 | Kocaeli | Turkey | 41380 | |
| 397 | TUR005 | Konya | Turkey | 42075 | |
| 398 | TUR001 | Mersin | Turkey | 33079 | |
| 399 | UKR001 | Kharkiv | Kharkivs'ka Oblast | Ukraine | 61124 |
| 400 | UKR007 | Kherson | Khersons'ka Oblast | Ukraine | 73003 |
| 401 | UKR005 | Poltava | Poltavs'ka Oblast | Ukraine | 36010 |
| 402 | UKR012 | Dnipro | Ukraine | 49102 | |
| 403 | UKR009 | Ivano-Frankivsk | Ukraine | 76018 | |
| 404 | UKR008 | Kyiv | Ukraine | 01033 | |
| 405 | UKR004 | Kyiv | Ukraine | 03038 | |
| 406 | UKR003 | Odesa | Ukraine | 65025 | |
| 407 | UKR010 | Vinnytsia | Ukraine | 21018 | |
| 408 | GBR001 | Cambridge | Cambridgeshire | United Kingdom | CB23 3RE |
| 409 | GBR015 | Exeter | Devon | United Kingdom | EX2 5DW |
| 410 | GBR017 | Norwich | Norfolk | United Kingdom | NR4 7UY |
| 411 | GBR013 | Llandough, Penarth | Vale Of Glamorgan, The | United Kingdom | CF64 2XX |
| 412 | GBR016 | Bradford | Yorkshire | United Kingdom | BD9 6RJ |
| 413 | GBR006 | Birmingham | United Kingdom | B9 5SS | |
| 414 | GBR002 | Chertsey | United Kingdom | KT16 0PZ | |
| 415 | GBR007 | Dundee | United Kingdom | DDI 9SY | |
| 416 | GBR004 | Liverpool | United Kingdom | L14 3PE | |
| 417 | GBR014 | Londonderry | United Kingdom | BT47 6SB | |
| 418 | GBR009 | London | United Kingdom | SW3 6NP | |
| 419 | GBR008 | Manchester | United Kingdom | M23 9LT | |
| 420 | GBR011 | Manchester | United Kingdom | M8 5RB | |
| 421 | GBR003 | Newcastle upon Tyne | United Kingdom | NE7 7DN | |
| 422 | GBR012 | Salford | United Kingdom | M6 8HD | |
| 423 | GBR018 | Southampton | United Kingdom | SO16 6YD | |
| 424 | GBR010 | Swansea | United Kingdom | SA6 6NL |
Sponsors and Collaborators
- Insmed Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Insmed Incorporated
ClinicalTrials.gov Identifier:
NCT04594369
Other Study ID Numbers:
- INS1007-301
- 2020-003688-25
First Posted:
Oct 20, 2020
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Insmed Incorporated
Additional relevant MeSH terms: