An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis

NCT05344508 | Unknown

• 1 other identifier: INS1007-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.

Conditions

Non-Cystic Fibrosis Bronchiectasis

Keywords

Cathepsin G; CKD-EPI; NCFBE

Interventions

Brensocatib DRUG

Brensocatib tablets

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant had agreed to provide their informed consent to participate per local requirements.
• Participant had successfully completed Clinical Trial INS 1007-301 ASPEN, including the End of study Visit 12 prior to receiving treatment.
• Requests for Post-Trial access for brensocatib had come from ASPEN investigator.
• Had received brensocatib treatment.

You may not qualify if:

• Participant had experienced a serious adverse event deemed to be related to brensocatib during the study and required permanent participant is continuation.
• The participant is immunocompromised or chronically treated with any investigational or commercialized immunomodulatory agent that is directed to any component of the adaptive or innate immune systems.
• Note: The use of any immunomodulatory agents (including but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, IFN-γ, and azathioprine) is prohibited during the program.
• The participant had undergone continuous use of high dose non-steroidal anti-inflammatory drugs.
• The participant had undergone chronic use of systemic steroids for any chronic condition, except steroids with topical anti-inflammatory activities (ie, oral budesonide).
• Participant had planned to receive live attenuated vaccines during the program (treatment must be postponed until 4 weeks after the last dose of drug).
• Participant had planned to use investigational drugs.

Sponsors & Collaborators

• Insmed Incorporated: lead

MeSH Terms

Interventions

brensocatib

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 25, 2022
• Last Updated: November 4, 2025

Record last verified: 2025-10