ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
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Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
132actual
Sites
99
Countries
Australia, Japan, South Korea +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Futility
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-09-11 | actual | When the study began enrolling |
| Primary completion | 2025-11-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-10 | actual | The whole study's end, after follow-up |
| First posted | 2024-05-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- MAC Lung Disease
- Treatment Refractory MAC Lung Disease
- Mycobacterium Infections, Nontuberculous
Interventions
- Drug: Clofazimine Inhalation Suspension — also filed as MNKD-101
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OF(Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for MAC) by the end of Month 6
measured Baseline to the end of Month 6
(Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A)
measured Baseline to end of Month 6
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