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NCT04677569 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
A Phase 3 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 425
- Enrollment target
NCT04677569 is a Phase 3 study that has completed, run by Insmed Incorporated. The registered enrollment target is 425 participants.
The verdict
NCT04677569, a Phase 3 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 425 participants
- Enrollment target
Study 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.
Interventions
- DRUG Azithromycin
- DRUG Ethambutol
- DRUG ALIS
- DRUG ELC (matching placebo for ALIS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-01-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04677569
The ClinicalTrials.gov registry entry for NCT04677569 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insmed Incorporated, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Azithromycin is the first listed.
NCT04677569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04677569 about?
NCT04677569 is a clinical study titled "Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex". 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.
What is the current status of trial NCT04677569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 425 participants. The study started on 2021-04-01. Estimated completion is 2026-01-15.
What interventions are being tested in trial NCT04677569?
The interventions under investigation include: Azithromycin (DRUG), Ethambutol (DRUG), ALIS (DRUG), ELC (matching placebo for ALIS) (DRUG).
Who is sponsoring clinical trial NCT04677569?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
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