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
About this trial
This is an expanded access trial for Non-Cystic Fibrosis Bronchiectasis focused on measuring Cathepsin G, CKD-EPI, NCFBE
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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
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