Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
NCT ID: NCT04677569
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
425 participants
INTERVENTIONAL
2021-04-01
2026-01-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALIS + Background Regimen
Participants will be administered 590 mg of ALIS (amikacin liposome inhalation suspension) once daily. Participants will also be administered azithromycin 250 mg and ethambutol 15 mg/kg, once daily.
ALIS
Inhalation via nebulization over approximately 6 to 15 minutes
Azithromycin
Oral tablet
Ethambutol
Oral tablet
ELC + Background Regimen
Participants will be administered ELC (empty liposome control), a visually matching placebo to ALIS (amikacin liposome inhalation suspension), once daily. Participants will also be administered azithromycin 250 mg and ETH (ethambutol) 15 mg/kg, once daily.
Azithromycin
Oral tablet
Ethambutol
Oral tablet
ELC (matching placebo for ALIS)
Inhalation via nebulization over approximately 6 to 15 minutes
Interventions
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ALIS
Inhalation via nebulization over approximately 6 to 15 minutes
Azithromycin
Oral tablet
Ethambutol
Oral tablet
ELC (matching placebo for ALIS)
Inhalation via nebulization over approximately 6 to 15 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as the dominant species is allowed, with MAC as the intended organism for treatment.
* A chest computerized tomography (CT) scan, read locally, within 6 months prior to Screening to determine presence and size of pulmonary cavities. Participants who do not have a chest CT scan within 6 months prior to Screening will be required to obtain a chest CT scan, read locally, during Screening.
* Willingness and ability to adhere to prescribed study treatment during the study.
* Women of childbearing potential (WOCBP) (ie, fertile following menarche and until becoming postmenopausal unless permanently sterile) and fertile men (ie, all men after puberty unless permanently sterile by bilateral orchidectomy) agree to practice a highly effective method of birth control from Day 1 to at least 90 days after the last dose. Examples of such birth controls are:
* true abstinence (refraining from heterosexual intercourse during the entire study),
* copper intrauterine device (IUD),
* hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \[combined with barrier method\]),
* exclusive homosexual relationship, or
* sole male partner who has undergone surgical sterilization with confirmation of azoospermia at least 3 months post procedure.
* Provide signed informed consent prior to administration of study drugs or performing any study-related procedure.
* Be able to comply with study drugs use, study visits, and study procedures as defined by the protocol.
* Men with partners who are WOCBP (pregnant or non-pregnant) agree to use condoms and non-pregnant partners should practice a highly effective method of birth control
Exclusion Criteria
* History of more than 3 MAC lung infections (a 4th MAC lung infection is not eligible)
* Received any mycobacterial antibiotic treatment for current MAC lung infection
* Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment
* Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6 months of cessation of prior successful treatment
* Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, during Screening or within 6 months prior to Screening
* Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening
* Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study
* Acute pulmonary exacerbation (eg, chronic obstructive pulmonary disease (COPD) or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (intravenous \[IV\] or oral), within 4 weeks prior to and during Screening
* Current smoker
* History of lung transplantation
* Prior exposure to ALIS (including clinical study)
* Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients
* Disseminated MAC infection
* Administration of any investigational drug within 8 weeks prior to Screening
* Known or suspected acquired immunodeficiency syndromes (Human Immunodeficiency Virus (HIV) -positive, regardless of CD4 counts). Other immunodeficiency syndromes that may interfere with study participation in the opinion of the Investigator
* Current alcohol, medication, or illicit drug abuse
* Known and active COVID-19 infection
* Known hypersensitivity or contraindications to use of ethambutol, azithromycin (including other macrolides or ketolides), or any of their excipients per local labeling guidance.
18 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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USA008
Birmingham, Alabama, United States
USA062
Fresno, California, United States
USA060
Los Angeles, California, United States
USA090
Newport Beach, California, United States
USA058
Sacramento, California, United States
USA048
San Diego, California, United States
USA081
San Francisco, California, United States
USA055
Santa Barbara, California, United States
USA050
Stanford, California, United States
USA001
Denver, Colorado, United States
USA023
Washington D.C., District of Columbia, United States
USA080
Bradenton, Florida, United States
USA028
Brandon, Florida, United States
USA003
Clearwater, Florida, United States
USA043
Jacksonville, Florida, United States
USA072
Jacksonville, Florida, United States
USA085
Jacksonville, Florida, United States
USA047
Jacksonville, Florida, United States
USA042
Kissimmee, Florida, United States
USA019
Leesburg, Florida, United States
USA039
Naples, Florida, United States
USA096
Naples, Florida, United States
USA097
Naples, Florida, United States
USA046
New Port Richey, Florida, United States
USA054
Sarasota, Florida, United States
USA084
Sebastian, Florida, United States
USA026
Sebring, Florida, United States
USA070
St. Petersburg, Florida, United States
USA014
St. Petersburg, Florida, United States
USA067
Tampa, Florida, United States
USA068
Tampa, Florida, United States
USA053
Weston, Florida, United States
USA038
Atlanta, Georgia, United States
USA066
Augusta, Georgia, United States
USA004
Lawrenceville, Georgia, United States
USA029
Rincon, Georgia, United States
USA079
Coeur d'Alene, Idaho, United States
USA031
Chicago, Illinois, United States
USA073
Springfield, Illinois, United States
USA030
Springfield, Illinois, United States
USA074
Iowa City, Iowa, United States
USA037
Kansas City, Kansas, United States
USA002
New Orleans, Louisiana, United States
USA017
Baltimore, Maryland, United States
USA099
Lexington, Massachusetts, United States
USA077
Springfield, Massachusetts, United States
USA013
Rochester, Minnesota, United States
USA082
Columbia, Missouri, United States
USA061
St Louis, Missouri, United States
USA045
Omaha, Nebraska, United States
USA009
Omaha, Nebraska, United States
USA069
Hillsborough, New Jersey, United States
USA032
Toms River, New Jersey, United States
USA065
Bayside, New York, United States
USA088
East Syracuse, New York, United States
USA011
New York, New York, United States
USA059
The Bronx, New York, United States
USA076
Charlotte, North Carolina, United States
USA035
Charlotte, North Carolina, United States
USA033
Charlotte, North Carolina, United States
USA051
Durham, North Carolina, United States
USA034
Mooresville, North Carolina, United States
USA007
Winston-Salem, North Carolina, United States
USA075
Cincinnati, Ohio, United States
USA064
Cincinnati, Ohio, United States
USA018
Cleveland, Ohio, United States
USA063
Columbus, Ohio, United States
USA071
Portland, Oregon, United States
USA025
Portland, Oregon, United States
USA015
DuBois, Pennsylvania, United States
USA040
Philadelphia, Pennsylvania, United States
USA093
Philadelphia, Pennsylvania, United States
USA092
Providence, Rhode Island, United States
USA044
Anderson, South Carolina, United States
USA024
Charleston, South Carolina, United States
USA020
Charleston, South Carolina, United States
USA012
Rock Hill, South Carolina, United States
USA022
Franklin, Tennessee, United States
USA041
Hendersonville, Tennessee, United States
USA078
Nashville, Tennessee, United States
USA016
Dallas, Texas, United States
USA100
Dallas, Texas, United States
USA091
Denison, Texas, United States
USA086
Houston, Texas, United States
USA021
McKinney, Texas, United States
USA006
San Antonio, Texas, United States
USA089
Temple, Texas, United States
USA052
Tyler, Texas, United States
USA083
Charlottesville, Virginia, United States
USA087
Madison, Wisconsin, United States
ARG004
Ciudad autAnoma de Buenos Aires, Buenos Aires, Argentina
ARG005
Quilmes, Buenos Aires, Argentina
ARG006
Villa Vatteone, Buenos Aires, Argentina
ARG003
CArdoba, CArdoba, Argentina
ARG002
Córdoba, CArdoba, Argentina
ARG001
Rosario, Santa Fe Province, Argentina
ARG007
San Miguel de Tucumán, Tucumán Province, Argentina
AUS006
Concord, New South Wales, Australia
AUS004
New Lambton Heights, New South Wales, Australia
AUS002
Westmead, New South Wales, Australia
AUS012
Birtinya, Queensland, Australia
AUS010
Chermside, Queensland, Australia
AUS013
Douglas, Queensland, Australia
AUS003
Greenslopes, Queensland, Australia
AUS016
Herston, Queensland, Australia
AUS014
Meadowbrook, Queensland, Australia
AUS001
South Brisbane, Queensland, Australia
AUS011
Woolloongabba, Queensland, Australia
AUS008
Adelaide, South Australia, Australia
AUS007
Clayton, Victoria, Australia
AUS009
Melbourne, Victoria, Australia
AUS015
Spearwood, Western Australia, Australia
AUS005
Perth, , Australia
AUT003
Wels, OberAsterreich, Austria
AUT001
Linz, Upper Austria, Austria
BEL003
Brussels, Brussels Capital, Belgium
BEL002
Ghent, , Belgium
BEL001
Leuven, , Belgium
CAN003
Winnepeg, Manitoba, Canada
CAN002
Toronto, Ontario, Canada
CAN004
Windsor, Ontario, Canada
CHL001
Curicó, Maule Region, Chile
CHL002
Quillota, , Chile
CHL004
Talca, , Chile
CHL003
Valparaíso, , Chile
DNK005
Vejle, Region Syddanmark, Denmark
DNK001
Roskilde, Zeeland, Denmark
DNK004
Aalborg, , Denmark
DNK002
Aarhus N, , Denmark
DNK003
Odensa C, , Denmark
FRA012
Nice, Alpes-Maritimes, France
FRA016
Strasbourg, Bas-Rhin, France
FRA015
Pessac, Gironde, France
FRA010
Suresnes, Hauts-de-Seine, France
FRA008
Nantes, Loire-Atlantique, France
FRA006
Amiens, , France
FRA005
Brest, , France
FRA007
Caen, , France
FRA002
Créteil, , France
FRA001
Marseille, , France
FRA014
Paris, , France
FRA009
Paris, , France
FRA013
Paris, , France
FRA004
Saint-Denis, , France
FRA003
Saint-Pierre, , France
FRA011
Toulouse, , France
GER001
Donaustauf, Bavaria, Germany
GER013
Gauting, Bavaria, Germany
GER005
München, Bavaria, Germany
GER012
Potsdam, Brandenburg, Germany
GER010
Immenhausen, Hesse, Germany
GER003
Borstel, Lower Saxony, Germany
GER014
Cologne, North Rhine-Westphalia, Germany
GER011
Cologne, North Rhine-Westphalia, Germany
GER008
Berlin, , Germany
GER006
Dresden, , Germany
GER009
Essen, , Germany
GER002
Frankfurt, , Germany
GER004
Freiburg im Breisgau, , Germany
GER007
Hanover, , Germany
GRC002
Athens, Attica, Greece
GRC003
Alexandroupoli, , Greece
GRC001
Heraklion, , Greece
HUN002
Budapest, , Hungary
HUN001
Törökbálint, , Hungary
ISR008
Tel Aviv, Tel Aviv, Israel
ISR001
Ashkelon, , Israel
ISR002
Beer-Yaakov, , Israel
ISR007
Haifa, , Israel
ISR005
Jerusalem, , Israel
ISR003
Petah Tikva, , Israel
ISR004
Ramat Gan, , Israel
ITA006
Modena, Emilia-Romagna, Italy
ITA011
Reggio Emilia, Emilia-Romagna, Italy
ITA010
Genoa, Liguria, Italy
ITA002
Milan, Milano, Italy
ITA008
Siena, Tuscany, Italy
ITA004
Florence, , Italy
ITA001
Milan, , Italy
ITA009
Milan, , Italy
ITA007
Monza, , Italy
ITA003
Pavia, , Italy
ITA005
Roma, , Italy
JPN011
Nagoya, Aiti, Japan
JPN020
Kita Kyushu-shi, Hukuoka, Japan
JPN022
Yokohama-Shi Tsuzuki-Ku, Kanagawa, Japan
JPN017
Matsusaka-Shi, Mie-ken, Japan
JPN018
Nagasaki, Nagasaki, Japan
JPN023
Kurashiki-Shi, Okayama-ken, Japan
JPN019
Izumo-Shi, Shimane, Japan
JPN014
Hamamatsu, Shizuoka, Japan
JPN015
Kiyose-Shi, Tokyo, Japan
JPN021
Ōta-ku, Tokyo, Japan
JPN008
Shinjuku-ku, Tokyo, Japan
JPN001
Fukui, , Japan
JPN004
Fukuoka, , Japan
JPN003
Jonan-ku, , Japan
JPN010
Kiyose, , Japan
JPN006
Nagano, , Japan
JPN012
Naka-gun, , Japan
JPN002
Sakaishi, , Japan
JPN009
Shimonoseki, , Japan
JPN005
Tokyo, , Japan
JPN016
Toyonaka-Shi, Ôsaka, Japan
NZL003
Hastings, Hawkes's Bay, New Zealand
NZL002
Hamilton, Waikato Region, New Zealand
NZL004
Auckland, , New Zealand
NZL001
Christchurch, , New Zealand
POL003
Kielce, Świętokrzyskie Voivodeship, Poland
PRT002
Braga, , Portugal
PRT003
Lisbon, , Portugal
KOR008
Ansan-si, Gyeonggido, South Korea
KOR005
Seongnam-si, Gyeonggido, South Korea
KOR007
Seongbuk-Gu, Seoul Teugbyeolsi, South Korea
KOR006
Incheon, , South Korea
KOR004
Seoul, , South Korea
KOR002
Seoul, , South Korea
KOR009
Seoul, , South Korea
KOR003
Seoul, , South Korea
KOR001
Seoul, , South Korea
ESP009
L'Hospitalet de Llobregat, Barcelona, Spain
ESP007
Vigo, Pontevedra, Spain
ESP002
Barcelona, , Spain
ESP008
Barcelona, , Spain
ESP003
Barcelona, , Spain
ESP005
Girona, , Spain
ESP010
Madrid, , Spain
ESP001
Madrid, , Spain
ESP004
Madrid, , Spain
ESP011
Pamplona, , Spain
ESP006
Pontevedra, , Spain
ESP012
Seville, , Spain
TWN004
Chiayi City, Chiayi, Taiwan
TWN001
Douliu, , Taiwan
TWN012
Hsinchu, , Taiwan
TWN005
Kaohsiung City, , Taiwan
TWN003
Kaohsiung City, , Taiwan
TWN007
New Taipei City, , Taiwan
TWN006
Taipei, , Taiwan
TWN011
Taipei, , Taiwan
TWN010
Taipei, , Taiwan
TWN008
Taipei, , Taiwan
TWN009
Taipei, , Taiwan
TWN002
Taipei, , Taiwan
TUR004
Maltepe, Istanbul, Turkey (Türkiye)
TUR003
Izmir, , Turkey (Türkiye)
TUR002
Kocaeli, , Turkey (Türkiye)
GBR009
Plymouth, Devon, United Kingdom
GBR012
Salford, Lancashire, United Kingdom
GBR013
Swansea, West Glamorgan, United Kingdom
GBR008
Birmingham, West Midlands, United Kingdom
GBR005
Aberdeen, , United Kingdom
GBR001
Cambridge, , United Kingdom
GBR002
Dundee, , United Kingdom
GBR004
Liverpool, , United Kingdom
GBR007
London, , United Kingdom
GBR010
London, , United Kingdom
GBR003
London, , United Kingdom
Countries
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Other Identifiers
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2020-003079-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505273-33-00
Identifier Type: OTHER
Identifier Source: secondary_id
INS-416
Identifier Type: -
Identifier Source: org_study_id