NCT06418711Phase 3Terminated

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-11-10Actual

Enrollment · participants132Actual

Source updated2025-11-12Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-12 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~234 participants (planned)~~

+ After

132 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~1 Aug 2026~~

+ After

10 Nov 2025

Recruitment status changed

− Before

~~Recruiting~~

+ After

Terminated

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Study details

Conditions studied

MAC Lung Disease; Treatment Refractory MAC Lung Disease; Mycobacterium Infections, Nontuberculous

Treatments or interventions studied

Clofazimine Inhalation SuspensionDrugAlso known as MNKD-101
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: (Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for MAC) by the end of Month 6; description: (Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for MAC) by the end of Month 6 (Part A); timeFrame: Baseline to the end of Month 6; measure: (Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A); description: (Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A); timeFrame: Baseline to end of Month 6

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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