Status:
ACTIVE_NOT_RECRUITING
A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis (Lenticlair™ 1)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is open to adult men with cystic fibrosis and adult women with cystic fibrosis who cannot have children. People with cystic fibrosis can join if they are not eligible to receive cystic fibr...
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Cystic fibrosis (CF)-pulmonary phenotype and a confirmed diagnosis of CF:
- 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
- Stable CF disease with no pulmonary exacerbation 4 weeks prior to the screening visit and during the screening period and stable drug- and non-drug therapy for CF in the 4 weeks prior to dosing Further inclusion criteria apply.
- Key exclusion criteria:
- Trial participants not eligible for CFTRmt based on contraindications (e.g. liver failure) or who needed to withdraw CFTRmt due to intolerability are not appropriate candidates for this Phase I/II trial
- Trial participants requiring chronic use of systemic corticosteroids or immunosuppressants to treat another condition Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 4 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06515002
Start Date
November 4 2024
End Date
July 4 2028
Last Update
November 24 2025
Active Locations (10)
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1
HOP Gui de Chauliac
Montpellier, France, 34295
2
HOP Necker
Paris, France, 75015
3
Istituto G. Gaslini
Genova, Italy, 16147
4
Osp. Pediatrico Bambin Gesù
Roma, Italy, 00165