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Have you been diagnosed with mycobacterial lung infection caused by Mycobacterium avium complex (MAC) and haven’t yet started treatment?

You may be eligible to participate in a study that is evaluating a possible treatment for MAC lung infection

or call now

About the Study

Insmed Incorporated (the study sponsor) is evaluating the safety and efficacy of the study drug ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) in patients with newly diagnosed mycobacterial (MAC) lung infections who have not started treatment. This study aims to evaluate if the ALIS-based combination treatment in adults with new MAC lung infections is safe and effective.

This study (also called a clinical trial) will include adults from around the world with MAC lung infections. Enrolled participants will be in the study for up to 18 months and will visit the study site regularly. The study sponsor may cover travel expenses related to the study visits for the participant in applicable countries only.

About the Trial:

The purpose of this clinical trial is to evaluate an investigational drug for potential treatment of MAC lung infections and evaluate symptomatic improvement including effect on respiratory discomfort and fatigue. Participants will be randomly assigned into one of two groups:

  • ALIS + background regimen
    • Participants will take ALIS (amikacin liposome inhalation suspension), once daily. Participants will also take azithromycin and ethambutol, once daily.
  • Placebo + background regimen
    • Participants will take a placebo, a drug that looks like ALIS but does not have any medicine in it, once daily. Participants will also take azithromycin and ethambutol, once daily.
Phase
Phase 3
Estimated Enrollment
250 participants

Can I Participate?

Your participation in the study could help increase the knowledge and understanding of MAC lung infections to potentially benefit the broader MAC community. You may be able to participate in the study if you meet the following key criteria:

Inclusion Criteria

Participants must

  • Be at least 18 years old;
  • Have a current diagnosis of MAC lung infection;
  • Have a chest CT scan within 6 months prior to Screening to determine presence and size of pulmonary cavities. If you have not had a chest CT scan within 6 months prior to Screening, you will be required to have one;
  • Be able to attend study visits and complete study assessments.

Exclusion Criteria

Participants must not have

  • A diagnosis of Cystic Fibrosis (CF);
  • A history of more than 3 MAC lung infections;
  • Received any mycobacterial antibiotic treatment for current MAC lung infection.
Other eligibility criteria apply

What Will Happen in This Study

If you are interested in joining this study, you will need to visit a clinical study site. A doctor will explain the study to you. If you agree to join, by reviewing and signing the Informed Consent Form (ICF), the doctors and study staff will perform an evaluation and ask you questions about your medical history to make sure you are eligible to take part in the study.

If eligible and you decide to join the study, you will be seen by MAC experts and may receive a study treatment being evaluated for:

  • Potential treatment of MAC lung infections.
  • Improving signs and symptoms of MAC lung infection including:
    • Decreased respiratory discomfort
    • Decreased fatigue

Your participation in the trial will last up to 18 months and will include regular study visits.

Full details about the study, visits, and examinations will be discussed with you before you decide to participate in the study.

What can you do next?

If you are interested in learning more about this study, take the following steps:

  1. Complete the prescreen questionnaire on this website
  2. Select a study site
  3. Share contact information with the study site coordinator
  4. Make contact and respond to the study site coordinator that you selected
  5. Share the NCT Identifier Number with your doctor: NCT04677569

Travel Support

Insmed Incorporated, the study sponsor, may cover travel expenses related to your study visits in applicable countries and only if applicable. Examples of expenses:

  • insmed airfare icon Airfare
  • insmed hotel icon Hotel
  • insmed meals icon Meals
  • insmed parking icon Parking fees

Additional information on travel support will be provided by the site staff should you decide to participate.

Where You Can Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
Emory University
Status
Recruiting
Location
Louisiana State University Health Sciences Center
Status
Not yet recruiting
Location
Aarhus Universitetshospital
Status
Not yet recruiting
Location
Aalborg Universitetshospital
Status
Not yet recruiting
Location
Baystate Medical Center
Status
Recruiting
Location
Odense Universitetshospital
Status
Not yet recruiting
Location
Aberdeen Royal Infirmary - PPDS
Status
Recruiting
Location
Montefiore Medical Center -111 East 210th Street
Status
Recruiting
Location
Asklepios Klinik München-Gauting
Status
Recruiting
Location
The Cleveland Clinic Foundation
Status
Not yet recruiting
Location
Lungenfachklinik Immenhausen
Status
Recruiting
Location
University of California San Francisco
Status
Recruiting
Location
ID Care Inc -Hillsborough -105 Raider
Status
Recruiting
Location
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Status
Recruiting
Location
Lady Davis Carmel Medical Center
Status
Not yet recruiting
Location
Logan Hospital
Status
Not yet recruiting
Location
Medizinische Hochschule Hannover
Status
Recruiting
Location
Metroplex Pulmonary and Sleep Medicine Center
Status
Recruiting
Location
Morriston Hospital - PPDS
Status
Recruiting
Location
University of Alabama at Birmingham
Status
Not yet recruiting
Location
Sarasota Memorial Healthcare System
Status
Recruiting
Location
Barts Health NHS Trust
Status
Recruiting
Location
Sheba Medical Center - PPDS
Status
Recruiting
Location
Infectious Disease Consultants of the Treasure Coast
Status
Not yet recruiting
Location
Universitätsklinikum Essen
Status
Recruiting
Location
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Status
Recruiting
Location
Universitätsklinikum Freiburg
Status
Recruiting
Location
University of Iowa
Status
Recruiting
Location
University of Texas Health Science Center at Tyler
Status
Recruiting
Location
University of Southern California
Status
Not yet recruiting
Location
University of Wisconsin School of Medicine and Public Health
Status
Not yet recruiting
Location
Westmead Hospital-Redbank Rd
Status
Not yet recruiting
Location
Santa Barbara Cottage Hospital
Status
Recruiting
Location
UCSF Fresno
Status
Recruiting
Location
St. Joseph’s Comprehensive Research Institute
Status
Recruiting
Location
Evangelische Lungenklinik Berlin
Status
Recruiting
Location
University of Kansas Medical Center
Status
Recruiting
Location
Stanford University
Status
Recruiting
Location
Hospital of The University of Pennsylvania
Status
Recruiting
Location
Sjællands Universitetshospital, Roskilde
Status
Not yet recruiting
Location
Lowcountry Infectious Diseases PA
Status
Recruiting
Location
University of Virginia
Status
Recruiting
Location
Dr Anil Dhar Professional Medicine Corporation
Status
Recruiting
Location
Ohio State University
Status
Not yet recruiting
Location
Augusta University
Status
Recruiting
Location
SUNY Upstate Medical Center
Status
Recruiting
Location
Georgetown University Hospital
Status
Recruiting
Location
Tel Aviv Sourasky Medical Center - PPDS
Status
Not yet recruiting
Location
University of California Davis Medical Center
Status
Recruiting
Location
Princess Alexandra Hospital
Status
Recruiting
Location
University of South Florida
Status
Recruiting
Location
Kepler Universitätsklinikum Linz
Status
Recruiting
Location
University of Cincinnati
Status
Recruiting
Location
Oregon Health and Science University
Status
Recruiting
Location
Clinical Research of Rock Hill
Status
Recruiting
Location
Birmingham Heartlands Hospital
Status
Recruiting
Location
Hadassah Medical Center - PPDS
Status
Recruiting
Location
University of Otago
Status
Recruiting
Location
Southern Illinois University School of Medicine
Status
Recruiting
Location
University of Florida
Status
Recruiting
Location
NYU Langone Medical Center
Status
Recruiting
Location
John Hopkins Institute for Clinical and Translational Research
Status
Recruiting
Location
Pasedena Center for Medical Research
Status
Not yet recruiting
Location
Nova Clinical Research, LLC
Status
Recruiting
Location
Royal Adelaide Hospital
Status
Recruiting
Location
Element Research Group - Clinedge - PPDS
Status
Not yet recruiting
Location
P3 Research-205 Hastings Street S
Status
Recruiting
Location
Plymouth Hospitals NHS Trust
Status
Recruiting
Location
Azienda Ospedaliera Universitaria Careggi
Status
Recruiting
Location
Azienda Ospedaliero Universitaria Di Modena Policlinico
Status
Recruiting
Location
TriHealth Bethesda North Hospital - Thomas Center
Status
Not yet recruiting
Location
Monash Medical Centre
Status
Recruiting
Location
Centricity Research - Roswell - HyperCore - PPDS
Status
Not yet recruiting
Location
Fondazione IRCCS Policlinico San Matteo di Pavia
Status
Recruiting
Location
Kootenai Clinic - Infectious Disease
Status
Recruiting
Location
Vanderbilt University Medical Center
Status
Recruiting
Location
Mayo Clinic Jacksonville - PPDS
Status
Not yet recruiting
Location
Baylor Scott and White Health
Status
Not yet recruiting
Location
Ospedale S. Giuseppe Multimedica
Status
Recruiting
Location
Clinical Trials Center of Middle Tennessee
Status
Not yet recruiting
Location
Lone Star Lung & Sleep Clinic
Status
Recruiting
Location
Greenslopes Private Hospital
Status
Recruiting
Location
Atrium Health ID Kenilworth
Status
Recruiting
Location
Rabin Medical Center - PPDS
Status
Recruiting
Location
Premier Pulmonary Critical Care & Sleep Medicine
Status
Recruiting
Location
AnMed Health Clinical Research
Status
Recruiting
Location
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza – A. O. San Gerardo
Status
Recruiting
Location
University of California San Diego Medical Center
Status
Recruiting
Location
Southeastern Research Center
Status
Not yet recruiting
Location
Northwestern Memorial Hospital
Status
Not yet recruiting
Location
Status
Not yet recruiting
Location
Medical University of South Carolina - PPDS
Status
Recruiting
Location
Insight Clinical Research, LLC
Status
Not yet recruiting
Location
Royal Brompton Hospital
Status
Recruiting
Location
Barzilai Medical Center
Status
Recruiting
Location
Fondazione Policlinico Universitario A Gemelli-Rome
Status
Recruiting
Location
Klinikum Köln-Merheim
Status
Recruiting
Location
Krankenhaus der Augustinerinnen
Status
Recruiting
Location
Royal Brisbane and Women's Hospital
Status
Recruiting
Location
St. Francis Medical Institute - Clinedge - PPDS
Status
Not yet recruiting

FAQs

About the Sponsor

Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases.