2023-504909-37-00
Not yet recruiting
Phase 1/2
A clinical trial to evaluate the long-term safety and durability of efficacy of BI 3720931, an inhaled lentiviral vector gene therapy, after single dose administration in a previous clinical trial in people with cystic fibrosis rolled-over from a previous clinical trial with BI 3720931 (LenticlairTM-ON).
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.6 sites in 4 countries12 target enrollmentStarted: June 17, 2024Last updated:
Overview
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Enrollment
- 12
- Locations
- 6
- Primary Endpoint
- Occurrence of treatment-emergent delayed AEs defined as new malignancies, new serious neurologic disorders, new serious rheumatologic or autoimmune disorders, new serious hematologic disorders, or new serious potentially product-related infections, until 15 years from enrolment
Overview
Brief Summary
The primary objective is to investigate long-term safety in trial participants treated with at least one dose of BI 3720931.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Long term follow-up
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All trial participants who participated in a previous BI sponsored trial with BI 3720931 and have received at least one dose of BI 3720931, or matching placebo, are eligible for participation in extension trial 1504-0003 and should be enrolled.
- •Signed and dated written informed consent in accordance with International Council for Harmonisation (ICH)-Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
Exclusion Criteria
- •There are no exclusion criteria for enrolment into the trial.
Outcomes
Primary Outcomes
Occurrence of treatment-emergent delayed AEs defined as new malignancies, new serious neurologic disorders, new serious rheumatologic or autoimmune disorders, new serious hematologic disorders, or new serious potentially product-related infections, until 15 years from enrolment
Occurrence of treatment-emergent delayed AEs defined as new malignancies, new serious neurologic disorders, new serious rheumatologic or autoimmune disorders, new serious hematologic disorders, or new serious potentially product-related infections, until 15 years from enrolment
Secondary Outcomes
- Time to loss of efficacy defined as the drop to below 5% (absolute) above baseline in forced expiratory volume in 1 second, percent of predicted value (FEV1pp)
- Time to first PEX from dosing
- Occurrence of AEs up to 2 years after enrolment
- Occurrence of serious adverse events (SAEs) throughout the study (up to 15 years)
- Occurrence of replication-competent lentivirus (RCL) throughout the study (up to 15 years)
Investigators
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
Study Sites (6)
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