NCT04594369

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,767 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 12 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	Brensocatib 10 mg	Oral tablet.
DRUG	Brensocatib 25 mg	Oral tablet.
DRUG	Placebo	Brensocatib-matching oral tablet.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2020-10-20
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

373 sites across 36 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Serbia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study