NCT03218917

Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

Detailed description

Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Conditions

• Non-Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	Brensocatib 10 mg	Administered once per day for 24 weeks
DRUG	Brensocatib 25 mg	Administered once per day for 24 weeks
DRUG	Placebo	Administered once per day for 24 weeks

Timeline

• Start date: 2017-10-31
• Primary completion: 2019-12-12
• Completion: 2019-12-12
• First posted: 2017-07-17
• Last updated: 2023-03-27
• Results posted: 2023-02-08

Locations

108 sites across 14 countries: United States, Australia, Belgium, Bulgaria, Denmark, Germany, Italy, Netherlands, New Zealand, Poland, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study