NCT06962852Active, not recruitingPhase 1/2
A long-term study to monitor the health status of people with cystic fibrosis who took part in a previous study with BI 3720931 (LenticlairTM-ON)
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).
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2026
Brief summary (registry, in English)
The primary objective is to investigate long-term safety in trial participants treated with at least one dose of BI 3720931.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 31 Jan 2024
- Start date
- 3 Jul 2025
- Lead sponsor
- Boehringer Ingelheim International GmbH
- Diseases
- Cystic fibrosis
- EU CT number
- 2023-504909-37-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- 6 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- There are no exclusion criteria for enrolment into the trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vall D'hebron Institut De Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Giannina Gaslini Institute For Scientific Hospitalization And Care Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.