Trial · NCT02628600

Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212

NCT02628600, Phase 3, Completed, Insmed Incorporated; results first posted 2019-11-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212. Trials, record NCT02628600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02628600

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
NCT number: NCT02628600
Status: Completed
Phases: Phase 3
Enrollment: 163 participants, actual
Lead sponsor: Insmed Incorporated
Conditions: NTM Lung Infection Due to MAC
Interventions: LAI 590 mg, Multi-drug regimen
First posted: 2015-12-11
Last updated: 2020-02-10
Other registries' IDs: eudract:2015-003170-33
Results first posted: 2019-11-19

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From baseline to 28 days after end of treatment, up to 13 months	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.
Secondary	Number of Participants Achieving Culture Conversion by Month 6 and Month 12	by Month 6 and Month 12	6 months: Converters are defined as participants who had 3 consecutive monthly MAC-negative sputum cultures by Month 6 (last opportunity to convert was at Month 4). 12 months: Converters are defined as participants who had 3 consecutive monthly MAC-negative sputum cultures by Month 12 (last opportunity to convert was at Month 10).
Secondary	Time to Culture Conversion	by Month 12	The time to culture conversion is defined as the date of conversion for participants achieving culture conversion is defined as the date of the first of 3-consecutive monthly negative sputum cultures. Then, the number of days to culture conversion is defined as the difference between the date of conversion and the date of first dose of LAI.
Secondary	Change From Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance	From baseline to Month 12 or end of treatment	A 6-minute walk assessment of exertional capability was performed at Baseline (Day 1) and Month 6 and Month 12/EOT. The standardized protocol based on the American Thoracic Society (ATS) guidelines (http://doi.org/10.1164/ajrccm.166.1.at1102) was used. After assessments were performed for heart rate, blood pressure, pulse oximetry (SpO2), dyspnea, and overall fatigue using the Borg scale, participants were instructed to walk on a prescribed course as far as they could in 6 minutes. Pre-test assessment parameters were repeated after exertion. The maximum distance achieved and post exertion heart rate and SpO2 were compared to pre-test values. The maximum distance achieved was recorded in the electronic case report form.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From baseline to 28 days after end of treatment, up to 13 months	Safety population	participants	NUMBER
SECONDARY	Number of Participants Achieving Culture Conversion by Month 6 and Month 12	by Month 6 and Month 12	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Culture Conversion	by Month 12	The Safety population was the set of all enrolled participants who received at least 1 dose of LAI.	months	MEDIAN
SECONDARY	Change From Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance	From baseline to Month 12 or end of treatment	Baseline: number of participants with data at this visit.~Change from baseline: number of participants with both baseline and 6 month scores.	meters	MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior LAI + Multidrug Regimen	≥1 Treatment-emergent AE (TEAE)	68	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior Multidrug Regimen Alone	≥1 Treatment-emergent AE (TEAE)	90	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior LAI + Multidrug Regimen	≥1 Serious TEAE (sTEAE)	20	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior Multidrug Regimen Alone	≥1 Serious TEAE (sTEAE)	32	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior LAI + Multidrug Regimen	≥1 TEAE leading to study drug withdrawn	8	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior Multidrug Regimen Alone	≥1 TEAE leading to study drug withdrawn	24	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior LAI + Multidrug Regimen	≥1 TE AE Leading to LAI withdrawn	6	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior Multidrug Regimen Alone	≥1 TE AE Leading to LAI withdrawn	22	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior LAI + Multidrug Regimen	≥1 TEAE Leading to MDR for NTM withdrawn	4	participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Prior Multidrug Regimen Alone	≥1 TEAE Leading to MDR for NTM withdrawn	8	participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prior LAI + Multidrug Regimen	73
Overall Study	STARTED	Prior Multidrug Regimen Alone	90
Overall Study	Participant Discontinued the Study	Prior LAI + Multidrug Regimen	24
Overall Study	Participant Discontinued the Study	Prior Multidrug Regimen Alone	32
Overall Study	COMPLETED	Prior LAI + Multidrug Regimen	49
Overall Study	COMPLETED	Prior Multidrug Regimen Alone	58
Overall Study	NOT COMPLETED	Prior LAI + Multidrug Regimen	24
Overall Study	NOT COMPLETED	Prior Multidrug Regimen Alone	32

Source ClinicalTrials.gov

Adverse events110

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Prior LAI + Multidrug Regimen	4	73	5
other	Diarrhoea	Gastrointestinal disorders	Prior Multidrug Regimen Alone	9	90	11
other	Nausea	Gastrointestinal disorders	Prior LAI + Multidrug Regimen	5	73	6
other	Nausea	Gastrointestinal disorders	Prior Multidrug Regimen Alone	9	90	10
other	Fatigue	General disorders	Prior LAI + Multidrug Regimen	3	73	3
other	Fatigue	General disorders	Prior Multidrug Regimen Alone	13	90	13
other	Nasopharyngitis	Infections and infestations	Prior LAI + Multidrug Regimen	10	73	11
other	Nasopharyngitis	Infections and infestations	Prior Multidrug Regimen Alone	7	90	10
other	Infective exacerbation of bronchiectasis	Infections and infestations	Prior LAI + Multidrug Regimen	6	73	7
other	Infective exacerbation of bronchiectasis	Infections and infestations	Prior Multidrug Regimen Alone	10	90	10

1 to 10 of 110Source ClinicalTrials.gov

See all 110 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prior LAI + Multidrug Regimen	2	73
Total, all-cause mortality	Prior Multidrug Regimen Alone	4	90
Total, other adverse events	Prior LAI + Multidrug Regimen	45	73
Total, other adverse events	Prior Multidrug Regimen Alone	75	90
Total, serious adverse events	Prior LAI + Multidrug Regimen	20	73
Total, serious adverse events	Prior Multidrug Regimen Alone	32	90

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33326356	DERIVED	PubMed
41186908	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Prior LAI + Multidrug Regimen vs Prior Multidrug Regimen Alone: deaths from any cause	Trial comparisons
Prior LAI + Multidrug Regimen vs Prior Multidrug Regimen Alone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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