search
Back to results

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

Primary Purpose

Non-Cystic Fibrosis Bronchiectasis

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Brensocatib
Sponsored by
Insmed Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non-Cystic Fibrosis Bronchiectasis focused on measuring Cathepsin G, CKD-EPI, NCFBE

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2022
    Last Updated
    August 11, 2023
    Sponsor
    Insmed Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05344508
    Brief Title
    An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
    Official Title
    Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Insmed Incorporated

    4. Oversight

    5. 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.
    Detailed Description
    Participants will receive brensocatib 10 mg, oral tablets, once daily.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Cystic Fibrosis Bronchiectasis
    Keywords
    Cathepsin G, CKD-EPI, NCFBE

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Brensocatib
    Intervention Description
    Brensocatib tablets

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Insmed Medical Information
    Phone
    1-844-446-7633
    Email
    medicalinformation@insmed.com

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs