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

NCT ID: NCT05344508

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Cystic Fibrosis Bronchiectasis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brensocatib

Brensocatib tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insmed Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

INS1007-EAP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.