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A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

Primary Purpose

Cystic Fibrosis, Bronchiectasis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BI 1291583
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age of patients when signing the informed consent ≥18 years 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) 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 History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: at least 2 exacerbations, or 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. Patients must be able to provide spontaneous or induced sputum samples. Further inclusion criteria apply. Exclusion Criteria: Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) > 3.0x Upper limit of normal (ULN) at Visit 1 Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1 Absolute blood neutrophil count < 1,000/mm^3 (equivalent to < 1000 cells/μL or < 10^9 cells/L) at Visit 1 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 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. Further exclusion criteria apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BI 1291583 group

    Placebo group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Occurrence of Treatment emergent Adverse Events (TEAEs) up to 16 weeks from first drug administration

    Secondary Outcome Measures

    Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 8 after first drug administration
    Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval (AUCτ) for the first dose
    Maximum measured concentration of the analyte in plasma (Cmax) for the first dose
    Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss)
    Maximum measured concentration of the analyte in plasma (Cmax) at steady state (Cmax,ss)

    Full Information

    First Posted
    May 10, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05865886
    Brief Title
    A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
    Official Title
    A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Evaluating Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BI 1291583 One Tablet Once Daily Over 12 Weeks Versus Placebo in Adult Patients With Cystic Fibrosis Bronchiectasis (Clairafly™)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 27, 2023 (Anticipated)
    Primary Completion Date
    October 7, 2024 (Anticipated)
    Study Completion Date
    October 7, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis, Bronchiectasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BI 1291583 group
    Arm Type
    Experimental
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    BI 1291583
    Intervention Description
    BI 1291583
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matching BI 1291583
    Primary Outcome Measure Information:
    Title
    Occurrence of Treatment emergent Adverse Events (TEAEs) up to 16 weeks from first drug administration
    Time Frame
    up to 16 weeks
    Secondary Outcome Measure Information:
    Title
    Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 8 after first drug administration
    Time Frame
    at week 8
    Title
    Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval (AUCτ) for the first dose
    Time Frame
    up to 8 hours
    Title
    Maximum measured concentration of the analyte in plasma (Cmax) for the first dose
    Time Frame
    up to 8 hours
    Title
    Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss)
    Time Frame
    up to 12 weeks
    Title
    Maximum measured concentration of the analyte in plasma (Cmax) at steady state (Cmax,ss)
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age of patients when signing the informed consent ≥18 years 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) 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 History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: at least 2 exacerbations, or 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. Patients must be able to provide spontaneous or induced sputum samples. Further inclusion criteria apply. Exclusion Criteria: Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) > 3.0x Upper limit of normal (ULN) at Visit 1 Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1 Absolute blood neutrophil count < 1,000/mm^3 (equivalent to < 1000 cells/μL or < 10^9 cells/L) at Visit 1 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 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. Further exclusion criteria apply.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Boehringer Ingelheim
    Phone
    1-800-243-0127
    Email
    clintriage.rdg@boehringer-ingelheim.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
    IPD Sharing Time Frame
    After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
    IPD Sharing Access Criteria
    For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
    IPD Sharing URL
    https://www.mystudywindow.com/msw/datasharing
    Links:
    URL
    https://www.mystudywindow.com
    Description
    Related Info

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    A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

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