A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI 3720931 (Lenticlair™-ON)

Plain-language summary

This Phase 1/2 study by Boehringer Ingelheim monitors the long-term health of people with cystic fibrosis who took part in a previous study with the medicine BI 3720931; no additional BI 3720931 treatment is given here. Participants who previously received BI 3720931 stay in the study for 15 years with about 20 site visits (every 3 months for the first 2 years, then yearly), while those who received placebo stop once their group assignment is disclosed. At each visit doctors check participants' health, record any problems that could be related to BI 3720931, and perform lung function testing.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Active, not recruiting

Sponsor

Boehringer Ingelheim

Intervention

BI 3720931

Start date

5/20/2025

Estimated completion

10/29/2040

Countries

France, Italy, Netherlands, Spain, United Kingdom

Related genes

Locations

• Montpellier, France
• Roma, Italy
• Utrecht, Netherlands
• Barcelona, Spain
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion criteria:

1. Trial participants who participated in a previous BI sponsored trial with BI 3720931 and have received any dose of BI 3720931, or matching placebo
2. 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

There are no exclusion criteria for enrolment into the trial.