Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

425

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

November 15, 2025

Study Completion Date

January 15, 2026

Conditions
Mycobacterium Infections, Nontuberculous
Interventions
DRUG

ALIS

Inhalation via nebulization over approximately 6 to 15 minutes

DRUG

Azithromycin

Oral tablet

DRUG

Ethambutol

Oral tablet

DRUG

ELC (matching placebo for ALIS)

Inhalation via nebulization over approximately 6 to 15 minutes

Trial Locations (258)

110

TWN010, Taipei

116

TWN002, Taipei

300

TWN012, Hsinchu

613

TWN004, Chiayi City

640

TWN001, Douliu

807

TWN005, Kaohsiung City

813

TWN003, Kaohsiung City

1000

BEL003, Brussels

1051

NZL004, Auckland

1121

HUN002, Budapest

1307

GER006, Dresden

2045

HUN001, Törökbálint

2139

AUS006, Concord

2145

AUS002, Westmead

2305

AUS004, New Lambton Heights

3000

BEL001, Leuven

3001

AUS009, Melbourne

3168

AUS007, Clayton

3204

NZL002, Hamilton

4000

ARG007, San Miguel de Tucumán

DNK001, Roskilde

4029

AUS016, Herston

4032

AUS010, Chermside

4040

AUT001, Linz

4101

AUS001, South Brisbane

4102

AUS011, Woolloongabba

4120

AUS003, Greenslopes

4122

NZL003, Hastings

4131

AUS014, Meadowbrook

4575

AUS012, Birtinya

4600

AUT003, Wels

4814

AUS013, Douglas

5000

ARG002, Córdoba

AUS008, Adelaide

AUS005, Perth

DNK003, Odensa C

6000

FRA012, Nice

6163

AUS015, Spearwood

7100

DNK005, Vejle

8025

ESP008, Barcelona

8035

ESP003, Barcelona

8200

DNK002, Aarhus N

8461

NZL001, Christchurch

9000

BEL002, Ghent

DNK004, Aalborg

10002

TWN006, Taipei

TWN011, Taipei

10017

USA011, New York

10461

USA059, The Bronx

11217

TWN008, Taipei

11361

USA065, Bayside

11490

TWN009, Taipei

11527

GRC002, Athens

13057

USA088, East Syracuse

13125

GER008, Berlin

13285

FRA001, Marseille

13620

KOR005, Seongnam-si

14033

FRA007, Caen

14467

GER012, Potsdam

15355

KOR008, Ansan-si

15801

USA015, DuBois

16128

ITA010, Genoa

17007

ESP005, Girona

19104

USA040, Philadelphia

19107

USA093, Philadelphia

20007

USA023, Washington D.C.

20122

ITA001, Milan

20123

ITA009, Milan

20162

ITA002, Milan

20900

ITA007, Monza

22332

KOR006, Incheon

22903

USA083, Charlottesville

23561

TWN007, New Taipei City

23845

GER003, Borstel

27100

ITA003, Pavia

27103

USA007, Winston-Salem

28007

ESP010, Madrid

28034

ESP001, Madrid

28046

ESP004, Madrid

28117

USA034, Mooresville

28204

USA076, Charlotte

28273

USA035, Charlotte

29414

USA024, Charleston

29425

USA020, Charleston

29609

FRA005, Brest

29621

USA044, Anderson

29732

USA012, Rock Hill

30625

GER007, Hanover

30912

USA066, Augusta

31008

ESP011, Pamplona

31326

USA029, Rincon

31400

FRA011, Toulouse

32204

USA043, Jacksonville

32224

USA047, Jacksonville

32958

USA084, Sebastian

33064

FRA015, Pessac

33331

USA053, Weston

33606

USA067, Tampa

33707

USA014, St. Petersburg

33765

USA003, Clearwater

33870

USA026, Sebring

34102

USA096, Naples

USA097, Naples

34209

USA080, Bradenton

34362

ISR007, Haifa

34376

GER010, Immenhausen

34652

USA046, New Port Richey

34746

USA042, Kissimmee

34748

USA019, Leesburg

34844

TUR004, Maltepe

35110

TUR003, Izmir

36001

ESP006, Pontevedra

36312

ESP007, Vigo

37067

USA022, Franklin

37075

USA041, Hendersonville

37232

USA078, Nashville

41013

ESP012, Seville

41124

ITA006, Modena

41380

TUR002, Kocaeli

42123

ITA011, Reggio Emilia

44000

FRA008, Nantes

44195

USA018, Cleveland

45127

GER009, Essen

45267

USA064, Cincinnati

50134

ITA004, Florence

50678

GER014, Cologne

51109

GER011, Cologne

52621

ISR004, Ramat Gan

53100

ITA008, Siena

55905

USA013, Rochester

60611

USA031, Chicago

62702

USA030, Springfield

63110

USA061, St Louis

64239

ISR008, Tel Aviv

66160

USA037, Kansas City

67091

FRA016, Strasbourg

68124

USA045, Omaha

68198

USA009, Omaha

69590

GER002, Frankfurt

70112

USA002, New Orleans

70300

ISR002, Beer-Yaakov

71110

GRC001, Heraklion

75013

FRA014, Paris

75018

FRA009, Paris

75020

USA091, Denison

FRA013, Paris

75246

USA016, Dallas

USA100, Dallas

75708

USA052, Tyler

76508

USA089, Temple

78100

ISR001, Ashkelon

78258

USA006, San Antonio

79106

GER004, Freiburg im Breisgau

80054

FRA006, Amiens

80206

USA001, Denver

80335

GER005, München

82131

GER013, Gauting

83814

USA079, Coeur d'Alene

91120

ISR005, Jerusalem

92103

USA048, San Diego

92151

FRA010, Suresnes

92663

USA090, Newport Beach

93093

GER001, Donaustauf

93105

USA055, Santa Barbara

93701

USA062, Fresno

94000

FRA002, Créteil

94143

USA081, San Francisco

94305

USA050, Stanford

95817

USA058, Sacramento

97239

USA025, Portland

97405

FRA004, Saint-Denis

97448

FRA003, Saint-Pierre

1628655

JPN008, Shinjuku-ku

2260000

CHL002, Quillota

2340000

CHL003, Valparaíso

3440000

CHL001, Curicó

4910000

ISR003, Petah Tikva

35233-1711

USA008, Birmingham

90033-5313

USA060, Los Angeles

33511-5719

USA028, Brandon

32207-8567

USA072, Jacksonville

32209-6511

USA085, Jacksonville

34102-5444

USA039, Naples

34239-2913

USA054, Sarasota

33704-2733

USA070, St. Petersburg

33614-7101

USA068, Tampa

30342-2147

USA038, Atlanta

30046-3325

USA004, Lawrenceville

62702-4968

USA073, Springfield

52242-1081

USA074, Iowa City

21224-3057

USA017, Baltimore

02421

USA099, Lexington

01107

USA077, Springfield

65212-1000

USA082, Columbia

08844

USA069, Hillsborough

08755-8000

USA032, Toms River

28277-8915

USA033, Charlotte

27710-0001

USA051, Durham

45242-4402

USA075, Cincinnati

43210-1240

USA063, Columbus

97213-2982

USA071, Portland

02906

USA092, Providence

77070-1190

USA086, Houston

75069-8085

USA021, McKinney

53792-0001

USA087, Madison

C1426ABP

ARG004, Ciudad autAnoma de Buenos Aires

B1878FNR

ARG005, Quilmes

B1853AIK

ARG006, Villa Vatteone

X5003DCE

ARG003, CArdoba

S2000DTC

ARG001, Rosario

R2H 2A6

CAN003, Winnepeg

M5T 2S8

CAN002, Toronto

N8X-5A6

CAN004, Windsor

Unknown

CHL004, Talca

JPN003, Jonan-ku

JPN005, Tokyo

KOR001, Seoul

681 00

GRC003, Alexandroupoli

00168

ITA005, Roma

465-0065

JPN011, Nagoya

807-8556

JPN020, Kita Kyushu-shi

224-0032

JPN022, Yokohama-Shi Tsuzuki-Ku

515-0073

JPN017, Matsusaka-Shi

852-8501

JPN018, Nagasaki

710-0052

JPN023, Kurashiki-Shi

693-0021

JPN019, Izumo-Shi

434-8511

JPN014, Hamamatsu

204-0023

JPN015, Kiyose-Shi

143-8541

JPN021, Ōta-ku

910-8526

JPN001, Fukui

819-8555

JPN004, Fukuoka

204-8522

JPN010, Kiyose

380-0928

JPN006, Nagano

319-1113

JPN012, Naka-gun

591-8555

JPN002, Sakaishi

750-8520

JPN009, Shimonoseki

560-0045

JPN016, Toyonaka-Shi

25-751

POL003, Kielce

4710-243

PRT002, Braga

1796-001

PRT003, Lisbon

02841

KOR007, Seongbuk-Gu

03722

KOR004, Seoul

05505

KOR002, Seoul

06591

KOR009, Seoul

06973

KOR003, Seoul

08907

ESP009, L'Hospitalet de Llobregat

08003

ESP002, Barcelona

PL6 8BQ

GBR009, Plymouth

M6 8HD

GBR012, Salford

SA6 6NL

GBR013, Swansea

B9 5SS

GBR008, Birmingham

AB25 2ZN

GBR005, Aberdeen

CB2 OAY

GBR001, Cambridge

DD1 9SY

GBR002, Dundee

L14 3PE

GBR004, Liverpool

EC1A 7BE

GBR007, London

NW32QG

GBR010, London

SW3 6NP

GBR003, London

All Listed Sponsors
lead

Insmed Incorporated

INDUSTRY

NCT04677569 - Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex | Biotech Hunter | Biotech Hunter