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)

Boehringer Ingelheim

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cystic Fibrosis

Treatments: Genetic: BI 3720931

Study type: Interventional

Funder types: Industry

Identifiers

NCT06962852

1504-0003

U1111-1291-2932 (Registry Identifier)

2023-504909-37-00 (Registry Identifier)

Details and patient eligibility

About

This study is for people with cystic fibrosis who took part in a previous study with a medicine called BI 3720931. The main purpose of this study is to monitor the long-term health of participants who were treated with BI 3720931 in the previous study. Participants in this study do not receive additional treatment with BI 3720931.

Participants who previously took BI 3720931 are in this study for 15 years. Participants who previously took placebo are in the study only until it is disclosed that they were in the placebo group, after which they stop. Participants who previously took BI 3720931 visit the study site about 20 times. Participants visit once every 3 months during the first 2 years.

After that, they visit once a year. During study visits, doctors check the health of the participants and note any health problems that could have been caused by BI 3720931. They also do lung function tests to see if BI 3720931 helps people with cystic fibrosis in the long term.

Enrollment: 285 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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285 participants in 1 patient group

All trial participants

Experimental group

Description:

All trial participants who have received at least one dose of BI 3720931 or matching placebo in a previous trial with BI 3720931. Trial participants who received placebo in the previous trial do not need to be followed for 15 years; once the treatment in the previous trial has been unblinded, their participation in this trial is then terminated.

Treatment:

Genetic: BI 3720931