Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418711
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-08
Brief Title:
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 Clofazimine Inhalation Suspension
Sponsor:
Mannkind Corporation
Organization:
Mannkind Corporation
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICoN-1
Brief 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
An open label extension study Part B will be offered to qualified participants for treatment with Clofazimine Inhalation Suspension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None