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NCT06418711 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Mannkind Corporation.

Terminated
Registry status
Phase 3
Development phase
132
Enrollment target

NCT06418711: Clinical Trial Phase 3 study, sponsored by Mannkind Corporation.

NCT06418711 is a Phase 3 study that was terminated before completion, run by Mannkind Corporation. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06418711, a Phase 3 study, was terminated before completion, sponsored by Mannkind Corporation.

TERMINATED
Registry status
Phase 3
Development phase
132 participants
Enrollment target

Study Summary

This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)

Primary Outcome

(Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for MAC) by the end of Month 6 (Part A)

Interventions

  • DRUG Placebo
  • DRUG Clofazimine Inhalation Suspension

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2024-09-11
Est. Completion 2025-11-10
Phase Phase 3
Mannkind Corporation

42 total trials

Why NCT06418711 stopped before completion

NCT06418711 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT06418711 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06418711 about?

NCT06418711 is a clinical study titled "ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension". This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)

What is the current status of trial NCT06418711?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2024-09-11. Estimated completion is 2025-11-10.

What interventions are being tested in trial NCT06418711?

The interventions under investigation include: Placebo (DRUG), Clofazimine Inhalation Suspension (DRUG).

Who is sponsoring clinical trial NCT06418711?

This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06418711's enrollment target sits among peer trials

132 1588th of 2000 higher than 408 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06418711, the US trial registry maintained by the National Library of Medicine. NCT06418711 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.