CLINICAL TRIALS PROFILE FOR BRENSOCATIB

Clinical Trials for Brensocatib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT04594369 ↗	A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis	Recruiting	Insmed Incorporated	Phase 3	The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
NCT04817332 ↗	STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19	Completed	Insmed Incorporated	Phase 3	COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay. High rates of patients requiring mechanical ventilation and overwhelming intensive care unit capacity has been the major issue contributing to excess deaths in Italy and Spain during the pandemic and is likely to be a major issue in other countries such as the United Kingdom in the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1 target for COVID19 therapy. The investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.
NCT04817332 ↗	STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19	Completed	NHS Tayside	Phase 3	COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay. High rates of patients requiring mechanical ventilation and overwhelming intensive care unit capacity has been the major issue contributing to excess deaths in Italy and Spain during the pandemic and is likely to be a major issue in other countries such as the United Kingdom in the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1 target for COVID19 therapy. The investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.
NCT04817332 ↗	STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19	Completed	University of Dundee	Phase 3	COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 and no therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. The investigators hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay. High rates of patients requiring mechanical ventilation and overwhelming intensive care unit capacity has been the major issue contributing to excess deaths in Italy and Spain during the pandemic and is likely to be a major issue in other countries such as the United Kingdom in the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1 target for COVID19 therapy. The investigators recently conducted a large phase 2 study of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.
NCT05090904 ↗	A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis	Recruiting	Insmed Incorporated	Phase 2	The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis (CF) over the 4-week treatment period.

Clinical Trial Conditions for Brensocatib

Condition Name

Condition Name for
Intervention	Trials
Healthy Volunteers	2
Renal Impairment	1
Covid19	1
Cystic Fibrosis	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Fibrosis	2
Cystic Fibrosis	1
COVID-19	1
Bronchiectasis	1

Clinical Trial Locations for Brensocatib

Trials by Country

Trials by Country for
Location	Trials
United States	33
Japan	10
Australia	6
Spain	6
Malaysia	5

Trials by US State

Trials by US State for
Location	Trials
Texas	4
Florida	3
California	2
Wisconsin	2
Colorado	1

Clinical Trial Progress for Brensocatib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	1
Phase 1	5

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	5
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for Brensocatib

Sponsor Name

Sponsor Name for
Sponsor	Trials
Insmed Incorporated	8
NHS Tayside	1
University of Dundee	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	8
Other	2