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NCT05344508 Clinical Trial

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

Non-Cystic Fibrosis Bronchiectasis Clinical Trial

Official title:
Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05344508
Other study ID # INS1007-EAP
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date February 2024
Source Insmed Incorporated
Contact Insmed Medical Information
Phone 1-844-446-7633
Email medicalinformation@insmed.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical 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.

Description:

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

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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-?, 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Brensocatib
Brensocatib tablets

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Insmed Incorporated
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