An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
NCT ID: NCT05344508
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Brensocatib
Brensocatib tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
85 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Other Identifiers
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INS1007-EAP
Identifier Type: -
Identifier Source: org_study_id
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