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

NCT06418711 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-11-12

No results posted yet for this 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)

Conditions

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

Interventions

DRUG

Clofazimine Inhalation Suspension

Eligible participants will be randomized in a 2:1 ratio to 1 of 2 possible treatment assignments, Clofazimine Inhalation Suspension or Placebo.

DRUG

Placebo

Eligible participants will be randomized in a 2:1 ratio to 1 of 2 possible treatment assignments, Clofazimine Inhalation Suspension or Placebo.

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Wassim Fares, MD · Mannkind Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2025-11-10
Completion
2025-11-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418711 on ClinicalTrials.gov