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

• Conditions: Non-Cystic Fibrosis Bronchiectasis

• Registration Number: NCT05344508
• Lead Sponsor: Insmed Incorporated

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.

Detailed Description

Participants will receive brensocatib 10 mg, oral tablets, once daily.

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified