Status:
APPROVED_FOR_MARKETING
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
Lead Sponsor:
Insmed Incorporated
Conditions:
Non-Cystic Fibrosis Bronchiectasis
Eligibility:
All Genders
12-85 years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05344508
Last Update
November 4 2025
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