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

Mycobacterium Infections, Nontuberculous Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 Clofazamine Inhalation Suspension. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06418711
Study type Interventional
Source Mannkind Corporation
Contact Kelley Snodgres
Phone 8186615000
Email ICoN1research@mannkindcorp.com
Status Not yet recruiting
Phase Phase 3
Start date June 2024
Completion date December 1, 2028
View Details
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