A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis (Lenticlair™ 1)
NCT ID: NCT06515002
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2024-11-04
2028-07-04
Brief Summary
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This study has two phases. In Phase 1, participants are put in one of 3 groups, one group after the other. Each group gets a different dose of BI 3720931. Group 1 starts with the lowest dose, followed by group 2 with the middle and group 3 with the high dose. In Phase 2, participants are put into 3 groups by chance, but at the same time. 2 groups get different doses of BI 3720931 selected based on results of Phase 1, and 1 group gets placebo. All study participants get only 1 dose of BI 3720931 or placebo and they use a special inhaler to take the study medicine. The placebo inhaler looks like the BI 3720931 inhaler but does not contain any medicine. During the study, participants continue taking their usual medicines.
Doctors closely monitor participants' health at the study site for the first 3 days after receiving BI 3720931. Participants visit their doctors regularly thereafter. The doctors check the health of the participants and note any health problems that could have been caused by BI 3720931. Study participants regularly do a standard lung function test to measure how well their lungs are working. Participants, in either Phase 1 or Phase 2, are in the study for 7 months. After completion of this study, participants will take part in a long-term follow-up study (1504-0003).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Phase II will be a double-blind, placebo-controlled, dose expansion part with 3 arms: first arm investigating Phase II dose 1, second arm investigating Phase II dose 2, and third arm for placebo.
An interim analysis of the safety and efficacy data from Phase I will be used for the decision making to move to Phase II and the selection of doses in Phase II.
TREATMENT
QUADRUPLE
Study Groups
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Phase II: Dose group 1
BI 3720931
BI 3720931
Inhaler
Inhaler for application of BI 3720931 and placebo
Phase II: Dose group 2
BI 3720931
BI 3720931
Inhaler
Inhaler for application of BI 3720931 and placebo
Phase II: Placebo group
Placebo
Placebo
Inhaler
Inhaler for application of BI 3720931 and placebo
Phase I: Dose group 1 (low dose)
BI 3720931
BI 3720931
Inhaler
Inhaler for application of BI 3720931 and placebo
Phase I: Dose group 2 (medium dose)
BI 3720931
BI 3720931
Inhaler
Inhaler for application of BI 3720931 and placebo
Phase I: Dose group 3 (high dose)
BI 3720931
BI 3720931
Inhaler
Inhaler for application of BI 3720931 and placebo
Interventions
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BI 3720931
BI 3720931
Placebo
Placebo
Inhaler
Inhaler for application of BI 3720931 and placebo
Eligibility Criteria
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Inclusion Criteria
* Positive sweat chloride ≥60 mmol/L by pilocarpine iontophoresis OR
* Genotype with 2 identifiable CF-causing mutations accompanied by one or more clinical features if sweat chloride testing is between 30 and 59 mmol/L
* Trial participants who are not eligible for treatment with cystic fibrosis transmembrane conductance regulator modulator therapy (CFTRmt) due to their genotype with 2 identified CFTR-mutations (including Class I CFTR gene mutations) and are also not expected to become eligible during the trial according to investigator´s opinion
* Trial participants able to perform acceptable spirometric maneuvers according to American Thoracic Society/European Respiratory Society 2019 standards
* Forced expiratory volume in 1 second, percent of predicted value (FEV1pp) ≥50% and ≤100% of predicted normal at Visit 1. Predicted value based on Global Lung Initiative lung function reference equations
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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HOP Gui de Chauliac
Montpellier, , France
HOP Necker
Paris, , France
Istituto G. Gaslini
Genova, , Italy
Osp. Pediatrico Bambin Gesù
Roma, , Italy
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hospital Universitari Vall D Hebron
Barcelona, , Spain
University Hospital Llandough
Cardiff, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2023-503281-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-0800
Identifier Type: REGISTRY
Identifier Source: secondary_id
1504.1
Identifier Type: OTHER
Identifier Source: secondary_id
1504-0001
Identifier Type: -
Identifier Source: org_study_id
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