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
• Status: Available

Study information

• Verified date: May 2024
• Source: Insmed Incorporated
• Contact: Insmed Medical Information
• Phone: 1-844-446-7633
• Email: medicalinformation[@]insmed.com
• Is FDA regulated: No
• 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
• Gender: All
• Age group: 12 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.

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Non-Cystic Fibrosis Bronchiectasis

Intervention

Drug:
• Brensocatib
Brensocatib tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated