CLINICAL TRIALS PROFILE FOR ARIKAYCE KIT

All Clinical Trials for ARIKAYCE KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00558844 ↗	Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa	Completed	Insmed Incorporated	Phase 1/Phase 2	2008-01-01	This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa.
NCT00775138 ↗	Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.	Completed	Insmed Incorporated	Phase 2	2008-06-24	This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
NCT00777296 ↗	Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)	Completed	Insmed Incorporated	Phase 1/Phase 2	2007-02-22	A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.
NCT01315236 ↗	Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2012-04-19	The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoints.
NCT01315236 ↗	Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria	Completed	Insmed Incorporated	Phase 2	2012-04-19	The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease. The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoints.
NCT01315678 ↗	Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections	Completed	Insmed Incorporated	Phase 3	2012-02-29	A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients. The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.
NCT01316276 ↗	Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection	Completed	Insmed Incorporated	Phase 3	2012-10-05	The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.

Clinical Trial Conditions for ARIKAYCE KIT

Condition Name

Condition Name for ARIKAYCE KIT
Intervention	Trials
Cystic Fibrosis	4
Mycobacterium Infections, Nontuberculous	1
Pseudomonas Aeruginosa Infection	1
Bronchiectasis	1

Condition MeSH

Condition MeSH for ARIKAYCE KIT
Intervention	Trials
Cystic Fibrosis	5
Fibrosis	4
Infections	4
Pseudomonas Infections	3

Clinical Trial Locations for ARIKAYCE KIT

Trials by Country

Trials by Country for ARIKAYCE KIT
Location	Trials
United States	36
Canada	5
Hungary	5
Serbia	5
Poland	5

Trials by US State

Trials by US State for ARIKAYCE KIT
Location	Trials
Pennsylvania	3
Florida	2
Colorado	2
California	2
Alabama	2

Clinical Trial Progress for ARIKAYCE KIT

Clinical Trial Phase

Clinical Trial Phase for ARIKAYCE KIT
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	3
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for ARIKAYCE KIT
Clinical Trial Phase	Trials
Completed	7

Clinical Trial Sponsors for ARIKAYCE KIT

Sponsor Name

Sponsor Name for ARIKAYCE KIT
Sponsor	Trials
Insmed Incorporated	7
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for ARIKAYCE KIT
Sponsor	Trials
Industry	7
NIH	1