AzTrials
AzTrials

Mycobacterium Infections, NontuberculousPhase 3ENCORENCT04677569

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

A Phase 3 study testing ALIS, Azithromycin and Ethambutol in people with Mycobacterium Infections, Nontuberculous, run by Insmed Incorporated at 258 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mycobacterium Infections, Nontuberculous
What is being tested?
ALIS, Azithromycin and Ethambutol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
425 participants
Where
258 sitesin 23 countries
Study dates
1 Apr 2021to 15 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, ≥ 18 years of age (19 years or older in South Korea, 20 years or older in Japan).
  • 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),
Show all 13Show fewer
  • 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

Who cannot join

  • Diagnosis of cystic fibrosis (CF).
  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

258 sites in 23 countries.

258 sites in 23 countries

United States90 sites

  • USA044

    Anderson, South Carolina, 29621

  • USA038

    Atlanta, Georgia, 30342-2147

  • USA066

    Augusta, Georgia, 30912

  • USA017

    Baltimore, Maryland, 21224-3057

  • USA065

    Bayside, New York, 11361

  • USA008

    Birmingham, Alabama, 35233-1711

  • USA080

    Bradenton, Florida, 34209

  • USA028

    Brandon, Florida, 33511-5719

  • USA024

    Charleston, South Carolina, 29414

  • USA020

    Charleston, South Carolina, 29425

  • USA076

    Charlotte, North Carolina, 28204

  • USA035

    Charlotte, North Carolina, 28273

  • USA033

    Charlotte, North Carolina, 28277-8915

  • USA083

    Charlottesville, Virginia, 22903

  • USA031

    Chicago, Illinois, 60611

  • USA075

    Cincinnati, Ohio, 45242-4402

  • USA064

    Cincinnati, Ohio, 45267

  • USA003

    Clearwater, Florida, 33765

  • USA018

    Cleveland, Ohio, 44195

  • USA079

    Coeur d'Alene, Idaho, 83814

  • USA082

    Columbia, Missouri, 65212-1000

  • USA063

    Columbus, Ohio, 43210-1240

  • USA016

    Dallas, Texas, 75246

  • USA100

    Dallas, Texas, 75246

  • USA091

    Denison, Texas, 75020

  • USA001

    Denver, Colorado, 80206

  • USA015

    DuBois, Pennsylvania, 15801

  • USA051

    Durham, North Carolina, 27710-0001

  • USA088

    East Syracuse, New York, 13057

  • USA022

    Franklin, Tennessee, 37067

  • USA062

    Fresno, California, 93701

  • USA041

    Hendersonville, Tennessee, 37075

  • USA069

    Hillsborough, New Jersey, 08844

  • USA086

    Houston, Texas, 77070-1190

  • USA074

    Iowa City, Iowa, 52242-1081

  • USA043

    Jacksonville, Florida, 32204

  • USA072

    Jacksonville, Florida, 32207-8567

  • USA085

    Jacksonville, Florida, 32209-6511

  • USA047

    Jacksonville, Florida, 32224

  • USA037

    Kansas City, Kansas, 66160

  • USA042

    Kissimmee, Florida, 34746

  • USA004

    Lawrenceville, Georgia, 30046-3325

  • USA019

    Leesburg, Florida, 34748

  • USA099

    Lexington, Massachusetts, 02421

  • USA060

    Los Angeles, California, 90033-5313

  • USA087

    Madison, Wisconsin, 53792-0001

  • USA021

    McKinney, Texas, 75069-8085

  • USA034

    Mooresville, North Carolina, 28117

  • USA039

    Naples, Florida, 34102-5444

  • USA096

    Naples, Florida, 34102

  • USA097

    Naples, Florida, 34102

  • USA078

    Nashville, Tennessee, 37232

  • USA002

    New Orleans, Louisiana, 70112

  • USA046

    New Port Richey, Florida, 34652

  • USA011

    New York, New York, 10017

  • USA090

    Newport Beach, California, 92663

  • USA045

    Omaha, Nebraska, 68124

  • USA009

    Omaha, Nebraska, 68198

  • USA040

    Philadelphia, Pennsylvania, 19104

  • USA093

    Philadelphia, Pennsylvania, 19107

  • USA071

    Portland, Oregon, 97213-2982

  • USA025

    Portland, Oregon, 97239

  • USA092

    Providence, Rhode Island, 02906

  • USA029

    Rincon, Georgia, 31326

  • USA013

    Rochester, Minnesota, 55905

  • USA012

    Rock Hill, South Carolina, 29732

  • USA058

    Sacramento, California, 95817

  • USA006

    San Antonio, Texas, 78258

  • USA048

    San Diego, California, 92103

  • USA081

    San Francisco, California, 94143

  • USA055

    Santa Barbara, California, 93105

  • USA054

    Sarasota, Florida, 34239-2913

  • USA084

    Sebastian, Florida, 32958

  • USA026

    Sebring, Florida, 33870

  • USA073

    Springfield, Illinois, 62702-4968

  • USA030

    Springfield, Illinois, 62702

  • USA077

    Springfield, Massachusetts, 01107

  • USA061

    St Louis, Missouri, 63110

  • USA070

    St. Petersburg, Florida, 33704-2733

  • USA014

    St. Petersburg, Florida, 33707

  • USA050

    Stanford, California, 94305

  • USA067

    Tampa, Florida, 33606

  • USA068

    Tampa, Florida, 33614-7101

  • USA089

    Temple, Texas, 76508

  • USA059

    The Bronx, New York, 10461

  • USA032

    Toms River, New Jersey, 08755-8000

  • USA052

    Tyler, Texas, 75708

  • USA023

    Washington D.C., District of Columbia, 20007

  • USA053

    Weston, Florida, 33331

  • USA007

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan21 sites

  • JPN001

    Fukui, 910-8526

  • JPN004

    Fukuoka, 819-8555

  • JPN014

    Hamamatsu, Shizuoka, 434-8511

  • JPN019

    Izumo-Shi, Shimane, 693-0021

  • JPN003

    Jonan-ku

  • JPN020

    Kita Kyushu-shi, Hukuoka, 807-8556

  • JPN010

    Kiyose, 204-8522

  • JPN015

    Kiyose-Shi, Tokyo, 204-0023

  • JPN023

    Kurashiki-Shi, Okayama-ken, 710-0052

  • JPN017

    Matsusaka-Shi, Mie-ken, 515-0073

  • JPN006

    Nagano, 380-0928

  • JPN018

    Nagasaki, Nagasaki, 852-8501

  • JPN011

    Nagoya, Aiti, 465-0065

  • JPN012

    Naka-gun, 319-1113

  • JPN021

    Ōta-ku, Tokyo, 143-8541

  • JPN002

    Sakaishi, 591-8555

  • JPN009

    Shimonoseki, 750-8520

  • JPN008

    Shinjuku-ku, Tokyo, 1628655

  • JPN005

    Tokyo

  • JPN016

    Toyonaka-Shi, Ôsaka, 560-0045

  • JPN022

    Yokohama-Shi Tsuzuki-Ku, Kanagawa, 224-0032

Other trials in Japan

Australia16 sites

  • AUS008

    Adelaide, South Australia, 5000

  • AUS012

    Birtinya, Queensland, 4575

  • AUS010

    Chermside, Queensland, 4032

  • AUS007

    Clayton, Victoria, 3168

  • AUS006

    Concord, New South Wales, 2139

  • AUS013

    Douglas, Queensland, 4814

  • AUS003

    Greenslopes, Queensland, 4120

  • AUS016

    Herston, Queensland, 4029

  • AUS014

    Meadowbrook, Queensland, 4131

  • AUS009

    Melbourne, Victoria, 3001

  • AUS004

    New Lambton Heights, New South Wales, 2305

  • AUS005

    Perth, 5000

  • AUS001

    South Brisbane, Queensland, 4101

  • AUS015

    Spearwood, Western Australia, 6163

  • AUS002

    Westmead, New South Wales, 2145

  • AUS011

    Woolloongabba, Queensland, 4102

Other trials in Australia

France16 sites

  • FRA006

    Amiens, 80054

  • FRA005

    Brest, 29609

  • FRA007

    Caen, 14033

  • FRA002

    Créteil, 94000

  • FRA001

    Marseille, 13285

  • FRA008

    Nantes, Loire-Atlantique, 44000

  • FRA012

    Nice, Alpes-Maritimes, 6000

  • FRA014

    Paris, 75013

  • FRA009

    Paris, 75018

  • FRA013

    Paris, 75020

  • FRA015

    Pessac, Gironde, 33064

  • FRA004

    Saint-Denis, 97405

  • FRA003

    Saint-Pierre, 97448

  • FRA016

    Strasbourg, Bas-Rhin, 67091

  • FRA010

    Suresnes, Hauts-de-Seine, 92151

  • FRA011

    Toulouse, 31400

Other trials in France

Germany14 sites

  • GER008

    Berlin, 13125

  • GER003

    Borstel, Lower Saxony, 23845

  • GER014

    Cologne, North Rhine-Westphalia, 50678

  • GER011

    Cologne, North Rhine-Westphalia, 51109

  • GER001

    Donaustauf, Bavaria, 93093

  • GER006

    Dresden, 1307

  • GER009

    Essen, 45127

  • GER002

    Frankfurt, 69590

  • GER004

    Freiburg im Breisgau, 79106

  • GER013

    Gauting, Bavaria, 82131

  • GER007

    Hanover, 30625

  • GER010

    Immenhausen, Hesse, 34376

  • GER005

    München, Bavaria, 80335

  • GER012

    Potsdam, Brandenburg, 14467

Other trials in Germany

Spain12 sites

  • ESP002

    Barcelona, 08003

  • ESP008

    Barcelona, 8025

  • ESP003

    Barcelona, 8035

  • ESP005

    Girona, 17007

  • ESP009

    L'Hospitalet de Llobregat, Barcelona, 08907

  • ESP010

    Madrid, 28007

  • ESP001

    Madrid, 28034

  • ESP004

    Madrid, 28046

  • ESP011

    Pamplona, 31008

  • ESP006

    Pontevedra, 36001

  • ESP012

    Seville, 41013

  • ESP007

    Vigo, Pontevedra, 36312

Other trials in Spain

Taiwan12 sites

  • TWN004

    Chiayi City, Chiayi, 613

  • TWN001

    Douliu, 640

  • TWN012

    Hsinchu, 300

  • TWN005

    Kaohsiung City, 807

  • TWN003

    Kaohsiung City, 813

  • TWN007

    New Taipei City, 23561

  • TWN006

    Taipei, 10002

  • TWN011

    Taipei, 10002

  • TWN010

    Taipei, 110

  • TWN008

    Taipei, 11217

  • TWN009

    Taipei, 11490

  • TWN002

    Taipei, 116

Other trials in Taiwan

Italy11 sites

  • ITA004

    Florence, 50134

  • ITA010

    Genoa, Liguria, 16128

  • ITA002

    Milan, Milano, 20162

  • ITA001

    Milan, 20122

  • ITA009

    Milan, 20123

  • ITA006

    Modena, Emilia-Romagna, 41124

  • ITA007

    Monza, 20900

  • ITA003

    Pavia, 27100

  • ITA011

    Reggio Emilia, Emilia-Romagna, 42123

  • ITA005

    Roma, 00168

  • ITA008

    Siena, Tuscany, 53100

Other trials in Italy

United Kingdom11 sites

  • GBR005

    Aberdeen, AB25 2ZN

  • GBR008

    Birmingham, West Midlands, B9 5SS

  • GBR001

    Cambridge, CB2 OAY

  • GBR002

    Dundee, DD1 9SY

  • GBR004

    Liverpool, L14 3PE

  • GBR007

    London, EC1A 7BE

  • GBR010

    London, NW32QG

  • GBR003

    London, SW3 6NP

  • GBR009

    Plymouth, Devon, PL6 8BQ

  • GBR012

    Salford, Lancashire, M6 8HD

  • GBR013

    Swansea, West Glamorgan, SA6 6NL

Other trials in United Kingdom

South Korea9 sites

  • KOR008

    Ansan-si, Gyeonggido, 15355

  • KOR006

    Incheon, 22332

  • KOR007

    Seongbuk-Gu, Seoul Teugbyeolsi, 02841

  • KOR005

    Seongnam-si, Gyeonggido, 13620

  • KOR004

    Seoul, 03722

  • KOR002

    Seoul, 05505

  • KOR009

    Seoul, 06591

  • KOR003

    Seoul, 06973

  • KOR001

    Seoul

Other trials in South Korea

Argentina7 sites

  • ARG003

    CArdoba, CArdoba, X5003DCE

  • ARG004

    Ciudad autAnoma de Buenos Aires, Buenos Aires, C1426ABP

  • ARG002

    Córdoba, CArdoba, 5000

  • ARG005

    Quilmes, Buenos Aires, B1878FNR

  • ARG001

    Rosario, Santa Fe Province, S2000DTC

  • ARG007

    San Miguel de Tucumán, Tucumán Province, 4000

  • ARG006

    Villa Vatteone, Buenos Aires, B1853AIK

Other trials in Argentina

Israel7 sites

  • ISR001

    Ashkelon, 78100

  • ISR002

    Beer-Yaakov, 70300

  • ISR007

    Haifa, 34362

  • ISR005

    Jerusalem, 91120

  • ISR003

    Petah Tikva, 4910000

  • ISR004

    Ramat Gan, 52621

  • ISR008

    Tel Aviv, Tel Aviv, 64239

Other trials in Israel

Denmark5 sites

  • DNK004

    Aalborg, 9000

  • DNK002

    Aarhus N, 8200

  • DNK003

    Odensa C, 5000

  • DNK001

    Roskilde, Region Sjælland, 4000

  • DNK005

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Chile4 sites

  • CHL001

    Curicó, Maule Region, 3440000

  • CHL002

    Quillota, 2260000

  • CHL004

    Talca

  • CHL003

    Valparaíso, 2340000

Other trials in Chile

New Zealand4 sites

  • NZL004

    Auckland, 1051

  • NZL001

    Christchurch, 8461

  • NZL002

    Hamilton, Waikato Region, 3204

  • NZL003

    Hastings, Hawkes's Bay, 4122

Other trials in New Zealand

Belgium3 sites

  • BEL003

    Brussels, Brussels Capital, 1000

  • BEL002

    Ghent, 9000

  • BEL001

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • CAN002

    Toronto, Ontario, M5T 2S8

  • CAN004

    Windsor, Ontario, N8X-5A6

  • CAN003

    Winnepeg, Manitoba, R2H 2A6

Other trials in Canada

Greece3 sites

  • GRC003

    Alexandroupoli, 681 00

  • GRC002

    Athens, Attica, 11527

  • GRC001

    Heraklion, 71110

Other trials in Greece

Turkey (Türkiye)3 sites

  • TUR003

    Izmir, 35110

  • TUR002

    Kocaeli, 41380

  • TUR004

    Maltepe, Istanbul, 34844

Other trials in Turkey (Türkiye)

Austria2 sites

  • AUT001

    Linz, Upper Austria, 4040

  • AUT003

    Wels, OberAsterreich, 4600

Other trials in Austria

Hungary2 sites

  • HUN002

    Budapest, 1121

  • HUN001

    Törökbálint, 2045

Other trials in Hungary

Portugal2 sites

  • PRT002

    Braga, 4710-243

  • PRT003

    Lisbon, 1796-001

Other trials in Portugal

Poland1 site

  • POL003

    Kielce, Świętokrzyskie Voivodeship, 25-751

Other trials in Poland

About this study

Official title: ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

Being tested
ALIS, Azithromycin, Ethambutol, ELC (matching placebo for ALIS)
Keywords
Nontuberculous Mycobacterial Lung Infection, Mycobacterium avium complex, Arikayce®
Medical subject headings
Mycobacterium Infections, Nontuberculous, Mycobacterium avium-intracellulare Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALISDrug

    Also called Amikacin liposome inhalation suspension, ARIKAYCE®

    Inhalation via nebulization over approximately 6 to 15 minutes

  • AzithromycinDrug

    Also called AZI, Zithromax

    Oral tablet

  • EthambutolDrug

    Also called ETH, Myambutol

    Oral tablet

  • ELC (matching placebo for ALIS)Drug

    Also called Empty liposome control

    Inhalation via nebulization over approximately 6 to 15 minutes

Study groups in NCT04677569
Study groupRoleWhat they receive
ALIS + Background RegimenExperimentalParticipants 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.
Receives: Drug: ALIS; Drug: Azithromycin; Drug: Ethambutol
ELC + Background RegimenPlacebo comparatorParticipants 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.
Receives: Drug: Azithromycin; Drug: Ethambutol; Drug: ELC (matching placebo for ALIS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Respiratory Symptom Score at Month 13

    Measured: Baseline to Month 13

Secondary outcomes (13)

  1. Percentage of Participants Achieving Durable Culture Conversion at Month 15

    Measured: Month 15

  2. Change from Baseline in Fatigue Symptom Score at Month 13

    Measured: Baseline to Month 13

  3. Percentage of Participants Achieving Culture Conversion by Month 6

    Measured: Month 6

  4. Percentage of Participants Achieving Culture Conversion by Month 12

    Measured: Month 12

  5. Percentage of Participants Achieving Culture Conversion by Month 13

    Measured: Month 13

  6. Percentage of Participants Achieving Culture Conversion During Treatment

    Measured: Baseline to Month 12

  7. Time to Culture Conversion

    Measured: Baseline to Month 12

  8. Time to the First Negative Culture

    Measured: Baseline to Month 12

  9. Percentage of Participants Who Develop a Mycobacterium avium Complex (MAC) Isolate with Amikacin Minimum Inhibitory Concentration (MIC) ≥ 128 μg/mL More Than One Time

    Measured: Baseline to Month 15

  10. Percentage of Participants Achieving Culture Conversion and a Subsequent at Least one MAC Positive Culture in Agar Media or Broth Media in at Least 2 Consecutive Visits With Matching Species and Genome at Screening/ Baseline

    Measured: Baseline to Month 15

  11. Percentage of Participants Achieving Culture Conversion and a Subsequently have at least One MAC Positive Culture in Agar Media or Broth Media in at Least 2 Consecutive Visits With Differing Species and/or Genome at Screening/ Baseline

    Measured: Baseline to Month 15

  12. Percentage of Participants Meeting the Within-subject Meaningful Change Threshold as Reflected in the Change in Respiratory Symptom Scores Computed From Baseline to Month 13

    Measured: Baseline to Month 13

  13. Number of Participants Who Experience an Adverse Event (AEs)

    Measured: Baseline to Month 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start1 Apr 2021
  3. Primary completion21 Nov 2025
  4. Study completion15 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04677569
Sponsor's protocol ID
INS-416
Other IDs
2020-003079-16, 2023-505273-33-00, 2023
Acronym
ENCORE
Status last verified
Feb 2026
First submitted
16 Dec 2020
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Daley CL, Morimoto K, Thomson R, Van Braeckel E, Hasegawa N, Griffith DE, Flume PA, Chalmers JD, Winthrop KL, Loebinger MR, Serrano D, van Ingen J, Yuen DW, Hassan M, Wu P, Nevoret ML, Mange K, O'Donnell AE; ENCORE Study Group. Amikacin Liposome Inhalation Suspension in Newly Diagnosed Mycobacterium avium Complex Lung Disease: A Phase 3b, Double-blind, Randomized Clinical Trial (ENCORE). Am J Respir Crit Care Med. 2026 Sep 30:aamag530. doi: 10.1093/ajrccm/aamag530. Online ahead of print.

    PubMed 42814876

  • Mange KC, Serrano D, Hassan M, Nevoret ML, Yuen DW, McManus S, Podger L, Barnes B, Daley CL. Psychometric validation of the PROMIS Fatigue-Short Form 7a in adults with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease: the ARISE and ENCORE studies. J Patient Rep Outcomes. 2025 Oct 16;9(1):119. doi: 10.1186/s41687-025-00944-8.

    PubMed 41100013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALIS, Azithromycin and Ethambutol in people with Mycobacterium Infections, Nontuberculous, run by Insmed Incorporated at 258 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 258 sites in United States, Japan, Australia, France, Germany and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Respiratory Symptom Score at Month 13 (time frame: Baseline to Month 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04677569, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in