NCT02628600

Brief Summary

This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212 (NCT02344004).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2016

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 19, 2019

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

December 8, 2015

Results QC Date

October 15, 2019

Last Update Submit

January 21, 2020

Conditions

NTM Lung Infection Due to MAC

Keywords

ALISARIKAYCE

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    TEAEs are defined as those AEs that occurred on or after the date of first dose of study medication in INS-312 and within 28 days after the last dose. If it couldn't be determined whether the AE is treatment emergent due to a partial onset date, then it was classified as treatment emergent.

    From baseline to 28 days after end of treatment, up to 13 months

Secondary Outcomes (3)

  • Number of Participants Achieving Culture Conversion by Month 6 and Month 12

    by Month 6 and Month 12

  • Time to Culture Conversion

    by Month 12

  • Change From Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance

    From baseline to Month 12 or end of treatment

Study Arms (2)

Prior LAI + Multidrug Regimen

EXPERIMENTAL

Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR.

Drug: LAI 590 mgDrug: Multi-drug regimen

Prior Multidrug Regimen Alone

EXPERIMENTAL

Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR.

Drug: LAI 590 mgDrug: Multi-drug regimen

Interventions

LAI 590 mgDRUG

LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes

Also known as: Amikacin Liposome Inhalation Suspension (ALIS), ARIKAYCE®
Prior LAI + Multidrug RegimenPrior Multidrug Regimen Alone
Multi-drug regimenDRUG

Multidrug antimycobacterial regimen from study INS-212

Prior LAI + Multidrug RegimenPrior Multidrug Regimen Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • had successfully completed the Month 6 and End of Treatment visits in Study INS-212
  • had not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212.

You may not qualify if:

  • \. achieved culture conversion without relapse or recurrence in the Study INS-212 study by Month 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yamazaki Y, Nakagawa T, Jumadilova Z, Yuen D, Villa R, Hasegawa N. Management and Resolution of Hypersensitivity Pneumonitis-Related Events in Japanese Patients Treated with Amikacin Liposome Inhalation Suspension in the CONVERT and INS-312 Clinical Trials. Infect Dis Ther. 2025 Nov 4. doi: 10.1007/s40121-025-01247-7. Online ahead of print.

    PMID: 41186908DERIVED

  • Winthrop KL, Flume PA, Thomson R, Mange KC, Yuen DW, Ciesielska M, Morimoto K, Ruoss SJ, Codecasa LR, Yim JJ, Marras TK, van Ingen J, Wallace RJ Jr, Brown-Elliott BA, Coulter C, Griffith DE. Amikacin Liposome Inhalation Suspension for Mycobacterium avium Complex Lung Disease: A 12-Month Open-Label Extension Clinical Trial. Ann Am Thorac Soc. 2021 Jul;18(7):1147-1157. doi: 10.1513/AnnalsATS.202008-925OC.

    PMID: 33326356DERIVED

Results Point of Contact

Title
Kevin Mange (Senior Vice President, Clinical Development & Medical Affairs, ALIS)
Organization
Insmed Inc
kevin.mange@insmed.com
908-947-2651

Study Officials

  • Kevin Mange, MD

    Insmed Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 11, 2015

Study Start

February 5, 2016

Primary Completion

October 17, 2018

Study Completion

October 17, 2018

Last Updated

February 10, 2020

Results First Posted

November 19, 2019

Record last verified: 2020-01