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Lenticlair 1: BI 3720931 in Cystic Fibrosis
NCT06515002Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2024
- Primary completion
- Feb 2026
- Countries
- 5
- Sponsor
- Boehringer Ingelheim
- Modality
- Gene Editing, Gene Silencing, Inhalation Devices
- Drugs
- BI 3720931
- Conditions
- cystic fibrosis (CF)
01
Overview
Phase 2, randomised, double-blind trial of BI 3720931 in cystic fibrosis (CF) (6 arms), sponsored by Boehringer Ingelheim. Primary endpoints: Treatment-Emergent Adverse Events at 24 weeks and Forced Expiratory Volume in 1 second, percent of predicted value at 8 weeks. Started Nov 2024; status: terminated.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Phase I: Dose group 1 (low dose)
Open-label, single low dose of BI 3720931 via inhaler
Phase I: Dose group 2 (medium dose)
Open-label, single medium dose of BI 3720931 via inhaler
Phase I: Dose group 3 (high dose)
Open-label, single high dose of BI 3720931 via inhaler
Phase II: Dose group 1
Double-blind, single dose of BI 3720931 (dose 1) via inhaler
Phase II: Dose group 2
Double-blind, single dose of BI 3720931 (dose 2) via inhaler
Phase II: Placebo group
Double-blind, single dose of placebo via inhaler
03
Who it enrols
Adults with cystic fibrosis who are ineligible for CFTR modulators, have an FEV1pp between 50% and 100%, and are not on chronic systemic corticosteroids or immunosuppressants.
04
Endpoints
Primary
Treatment-Emergent Adverse Events
Forced Expiratory Volume in 1 second, percent of predicted value
Secondary
Treatment Response (FEV1pp >=5%)
Forced Expiratory Volume in 1 second, percent of predicted value
Dose Limiting Toxicities
Serious Adverse Events
Treatment-Emergent Adverse Events
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