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Do you have patients recently diagnosed with a nontuberculous mycobacterial lung infection caused by MAC? Before you start treatment consider referring them to a clinical research study.

Refer to the National Clinical Trial (NCT) identifier number: NCT04677569

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 Study Drug

Participants will be randomly assigned into one of two groups:

  • ALIS + background regimen
    • Participants will take 590 mg of ALIS (amikacin liposome inhalation suspension) once daily. Participants will also take azithromycin 250 mg and ethambutol 15 mg/kg, once daily.
  • Placebo + background regimen
    • Participants will take a placebo called ELC (empty liposome control), a drug that looks like ALIS (amikacin liposome inhalation suspension), once daily. Participants will also take azithromycin 250 mg and ETH (ethambutol) 15 mg/kg, once daily.

ENCORE Study Details

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. Enrolled participants will be in the study for up to 18 months and will visit the study site regularly.

Phase
Phase 3
Estimated Enrollment
250 Participants

Eligibility Criteria

Your patients may be able to participate in the study if they meet the following key criteria:

Inclusion Criteria

Participants must

  • Be at least 18 years old (or above the age of majority in local jurisdictions);
  • Have a current diagnosis of MAC lung infection and a positive sputum culture for MAC within 6 months prior to Screening as well as at Screening;
  • Have a chest CT scan within 6 months prior to Screening to determine presence and size of pulmonary cavities. If they have not had a chest CT scan within 6 months prior to Screening, they will be required to do so;
  • In the Investigator’s opinion, underlying lung disease (eg, COPD, bronchiectasis) have been well managed, and on stable maintenance therapy for a minimum of 4 weeks prior to enrolling;
  • Have the ability to produce (spontaneously or with induction) approximately 2 mL of sputum at Screening.

Exclusion Criteria

Participants must not have

  • A diagnosis of CF;
  • A history of more than 3 MAC lung infections;
  • Received any mycobacterial antibiotic treatment for current MAC lung infection;
  • A 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;
  • A relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤ 6 months of cessation of prior successful treatment;
  • MAC isolate with MIC for amikacin ≥ 128 µg/mL at Screening;
  • Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, within 6 months prior to Screening;
  • A radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening;
  • An 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;
  • An active pulmonary tuberculosis requiring treatment during Screening;
  • A hospitalization for underlying lung disease during Screening;
  • An acute pulmonary exacerbation (e.g., COPD or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (IV or oral), within 4 weeks prior to and during Screening;
  • Predicted forced expiratory volume in 1 second (FEV1) < 35%, pre-bronchodilator use;
  • A status as a current smoker;
  • A history of lung transplantation;
  • A use of inhaled or systemic aminoglycosides with activity against MAC (eg, amikacin, kanamycin, or streptomycin) during Screening;
  • A prior exposure to ALIS (including clinical study);
  • A known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients;
  • A disseminated MAC infection.
Other eligibility criteria apply

What Will Happen in This Study

Your patient will need to visit a clinical study site where a research staff and physician will explain the study to the patient. If they agree to participate by reviewing and signing the Informed Consent Form (ICF), the investigator and study staff will perform a screening evaluation to make sure they are eligible.

Patients who decide to participate in this study will take assigned trial treatment as intended until:

  • they choose to leave the study,
  • the investigator thinks it would be in the patient’s best interest to stop treatment with the study drug, or
  • the study ends

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

What can you do next?

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

  1. Take the prescreen questionnaire to confirm your patient’s eligibility
  2. Select the study site that’s closest to your patient
  3. Your patient will receive a confirmation that their information was submitted
  4. The site will reach out to your patient to schedule an appointment

Travel Support

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

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

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

Where Your Patient Can Join

Your patient will need to travel to one of the study clinics taking part in this clinical trial.

Location
Hospital Clinic de Barcelona
Status
Recruiting
Location
Aberdeen Royal Infirmary - PPDS
Status
Recruiting
Location
Aarhus Universitetshospital
Status
Recruiting
Location
Baystate Medical Center
Status
Recruiting
Location
Aalborg Universitetshospital
Status
Recruiting
Location
Hospital Universitario La Paz - PPDS
Status
Not yet recruiting
Location
Hospital Universitario Ramon y Cajal
Status
Recruiting
Location
Hospital del Mar
Status
Recruiting
Location
Taipei Veterans General Hospital
Status
Recruiting
Location
Kepler Universitätsklinikum Linz
Status
Recruiting
Location
Asklepios Klinik München-Gauting
Status
Recruiting
Location
The Cleveland Clinic Foundation
Status
Recruiting
Location
Hospital Provincial de Pontevedra
Status
Recruiting
Location
Duke University Medical Center
Status
Recruiting
Location
Lungenfachklinik Immenhausen
Status
Recruiting
Location
Hospital Universitari de Girona Dr Josep Trueta
Status
Recruiting
Location
ID Care Inc -Hillsborough -105 Raider
Status
Recruiting
Location
Lady Davis Carmel Medical Center
Status
Not yet recruiting
Location
Logan Hospital
Status
Recruiting
Location
Louisiana State University Health Sciences Center
Status
Recruiting
Location
Medizinische Hochschule Hannover
Status
Recruiting
Location
Metroplex Pulmonary and Sleep Medicine Center
Status
Recruiting
Location
Morriston Hospital - PPDS
Status
Recruiting
Location
Odense Universitetshospital
Status
Recruiting
Location
The Prince Charles Hospital
Status
Recruiting
Location
Royal Perth Hospital
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
Liverpool Heart and Chest Hospital
Status
Recruiting
Location
Sheba Medical Center - PPDS
Status
Not yet 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
Emory University
Status
Recruiting
Location
University of Texas Health Science Center at Tyler
Status
Recruiting
Location
University of Southern California
Status
Recruiting
Location
Westmead Hospital-Redbank Rd
Status
Recruiting
Location
Santa Barbara Cottage Hospital
Status
Recruiting
Location
UCSF Fresno
Status
Recruiting
Location
Medical Research of Central Florida - ClinEdge - PPDS
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
Recruiting
Location
Lowcountry Infectious Diseases PA
Status
Recruiting
Location
Concord Repatriation General Hospital
Status
Recruiting
Location
Clinica Universidad Navarra
Status
Recruiting
Location
Dr Anil Dhar Professional Medicine Corporation
Status
Recruiting
Location
Investigaciones en Patologias Respiratorias (IPR)
Status
Recruiting
Location
Ohio State University
Status
Recruiting
Location
Augusta University
Status
Recruiting
Location
Georgetown University Hospital
Status
Recruiting
Location
Tel Aviv Sourasky Medical Center PPDS
Status
Not yet recruiting
Location
Centro Respiratorio Quilmes
Status
Recruiting
Location
University of California Davis Medical Center
Status
Recruiting
Location
Princess Alexandra Hospital
Status
Recruiting
Location
ASST di Monza - Azienda Ospedaliera San Gerardo
Status
Recruiting
Location
University of South Florida
Status
Recruiting
Location
Royal Free Hospital
Status
Recruiting
Location
John Hunter Hospital
Status
Not yet 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
Hospital General Universitario Gregorio Marañon
Status
Recruiting
Location
Hadassah Medical Center - PPDS
Status
Not yet recruiting
Location
Southern Illinois University School of Medicine
Status
Recruiting
Location
NYU Langone Medical Center
Status
Recruiting
Location
Hospital Universitario de Bellvitge
Status
Recruiting
Location
John Hopkins Institute for Clinical and Translational Research
Status
Recruiting
Location
Pasedena Center for Medical Research
Status
Recruiting
Location
Nova Clinical Research, LLC
Status
Recruiting
Location
Instituto Médico de la Fundación Estudios Clínicos
Status
Recruiting
Location
Royal Adelaide Hospital
Status
Recruiting
Location
Element Research Group - Clinedge - PPDS
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
Recruiting
Location
Centricity Research - Roswell - HyperCore - PPDS
Status
Recruiting
Location
Kootenai Clinic - Infectious Disease
Status
Not yet recruiting
Location
Fondazione IRCCS Policlinico San Matteo di Pavia
Status
Recruiting
Location
The Cleveland Clinic Foundation
Status
Recruiting
Location
Clinical Research Specialists LLC
Status
Not yet recruiting
Location
Mayo Clinic Jacksonville - PPDS
Status
Recruiting
Location
National Jewish Health
Status
Recruiting
Location
Ospedale S. Giuseppe Multimedica
Status
Recruiting
Location
Clinical Trials Center of Middle Tennessee
Status
Recruiting
Location
Greenslopes Private Hospital
Status
Recruiting
Location
Atrium Health ID Kenilworth
Status
Recruiting
Location
Rabin Medical Center - PPDS
Status
Not yet recruiting
Location
AnMed Health Clinical Research
Status
Recruiting
Location
University of California San Diego Medical Center
Status
Recruiting
Location
Northwestern Memorial Hospital
Status
Recruiting
Location
Medical University of South Carolina - PPDS
Status
Recruiting
Location
Insight Clinical Research, LLC
Status
Recruiting
Location
Royal Brompton Hospital
Status
Recruiting
Location
Barzilai Medical Center
Status
Not yet recruiting
Location
Centro Médico Dra de Salvo - PPDS
Status
Recruiting
Location
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
Status
Recruiting
Location
CHUVI – H.U. Alvaro Cunqueiro
Status
Recruiting
Location
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Status
Recruiting
Location
Fondazione Policlinico Universitario A Gemelli
Status
Recruiting
Location
Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof Lis
Status
Recruiting
Location
Instituto De Enfermedades Respiratorias E Investigacion Medica
Status
Recruiting
Location
Instituto de Medicina Respiratoria, IMeR
Status
Recruiting
Location
Montefiore Medical Center -111 East 210th Street
Status
Recruiting
Location
National Taiwan University Hospital - YunLin Branch
Status
Recruiting
Location
Plymouth Hospitals NHS Trust
Status
Recruiting
Location
Royal Brisbane and Women's Hospital
Status
Recruiting
Location
Sanatorio Mayo Privado
Status
Recruiting
Location
St. Francis Medical Institute - Clinedge - PPDS
Status
Recruiting
Location
TrialsWest Pty Ltd
Status
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.