Non-Cystic Fibrosis BronchiectasisNCT05344508
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
A study testing Brensocatib in people with Non-Cystic Fibrosis Bronchiectasis, run by Insmed Incorporated.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- Brensocatib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis
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.
Read the detailed description
Participants will receive brensocatib 10 mg, oral tablets, once daily.
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- Brensocatib
- Keywords
- Cathepsin G, CKD-EPI, NCFBE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrensocatibDrug
Brensocatib tablets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344508
- Sponsor's protocol ID
- INS1007-EAP
- Status last verified
- Oct 2025
- First submitted
- 6 Apr 2022
- Last updated
- 4 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT05344508
- Acronym / sponsor ID
- INS1007-EAP
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Keywords
- Cathepsin G, CKD-EPI, NCFBE
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrensocatibBrensocatib tablets | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Brensocatib in people with Non-Cystic Fibrosis Bronchiectasis, run by Insmed Incorporated.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.