A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
NCT ID: NCT05865886
Last Updated: 2025-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2024-04-05
2024-10-07
Brief Summary
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The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group.
Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5 mg BI 1291583
BI 1291583
Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
Placebo
Placebo to BI 1291583
Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks.
Interventions
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BI 1291583
Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
Placebo to BI 1291583
Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Historical clinical diagnosis of Cystic fibrosis (CF) (symptoms of CF and sweat chloride ≥ 60 mmol/L and/or 2 CF-causing Cystic fibrosis transmembrane conductance regulator (CFTR) mutations)
3. Investigator-confirmed diagnosis of Bronchiectasis (BE) by Computed tomography (CT) scan and clinical history consistent with BE (e.g., cough, chronic sputum production, recurrent respiratory infections). Subjects whose past chest CT records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years
4. History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:
1. at least 2 exacerbations, or
2. at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening visit 1 For patients on stable oral or inhaled antibiotics as chronic treatment for BE, at least one exacerbation must have occurred while on stable antibiotics.
Exclusion Criteria
2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \< 30 mL/min at Visit 1
3. Absolute blood neutrophil count \< 1,000/mm\^3 (equivalent to \< 1000 cells/μL or \< 10\^9 cells/L) at Visit 1
4. Any findings in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) and/or laboratory value assessed at Visit 1 or during screening period that in the opinion of the investigator may put the patient at risk by participating in the trial
5. Positive serological tests for hepatitis B, hepatitis C (also confirmed with Hepatitis C virus ribonucleic acid (HCV RNA)), or human immunodeficiency virus (HIV) infection, or known infection status.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Northwell Health Physician Partners
New York, New York, United States
UZ Leuven
Leuven, , Belgium
Charite Universitätsmedizin Berlin KöR
Berlin, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena
Jena, , Germany
Azienda Ospedaliera Meyer
Florence, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Amsterdam UMC, location VUMC
Amsterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Countries
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References
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Badorrek P, Diefenbach C, Kogler H, Eleftheraki A, Seitz F, Hohlfeld JM. Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers. Clin Transl Sci. 2024 Aug;17(8):e13891. doi: 10.1111/cts.13891.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2022-502835-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-2567
Identifier Type: REGISTRY
Identifier Source: secondary_id
1397-0013
Identifier Type: -
Identifier Source: org_study_id
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