NCT06418711

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

ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Clofazimine Inhalation Suspension When Added to Guideline-Based Therapy in Participants With Nontuberculous Mycobacterial Infection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Randomized, double-blind, placebo-controlled study (Part A) designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT). The primary objective of this study will be to compare the efficacy of Clofazimine Inhalation Suspension versus placebo as assessed by the co-primary endpoints, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS). An open label extension study (Part B) will be offered to qualified participants for treatment with Clofazimine Inhalation Suspension.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-11
• Primary completion: 2025-11-10
• Completion: 2025-11-10
• First posted: 2024-05-17
• Last updated: 2025-11-12

Locations

99 sites across 5 countries: United States, Australia, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study