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

Sponsor
Insmed Incorporated (Industry)
Overall Status
Available
CT.gov ID
NCT05344508
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

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

Study Design

Study Type:
Expanded Access
Official Title:
Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Insmed Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Insmed Incorporated
    ClinicalTrials.gov Identifier:
    NCT05344508
    Other Study ID Numbers:
    • INS1007-EAP
    First Posted:
    Apr 25, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Insmed Incorporated
    Cathepsin G
    CKD-EPI
    NCFBE
    Additional relevant MeSH terms:
    Bronchiectasis
    Fibrosis

    Study Results

    No Results Posted as of Aug 4, 2022