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Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine

Primary Purpose

Bronchiectasis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 1291583
Placebo matching BI 1291583
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis

Eligibility Criteria

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

Inclusion Criteria: Patients who completed the treatment period in Phase II trials (1397-0012) as planned per protocol. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information. Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation. Exclusion Criteria: Laboratory and medical examination 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 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then). Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then). An absolute blood neutrophil count <1,000/mm^3 (equivalent to <1,000 cells/μL or <10^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then). Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the lab tests, if no more than 6 weeks passed since then), that in the opinion of the investigator may put the patient at risk by participating in the trial. New concomitant diagnosis and therapy A new diagnosis of Hypogammaglobulinemia Common variable immunodeficiency α1-antitrypsin deficiency being treated augmentation therapy Allergic bronchopulmonary aspergillosis being treated or requiring treatment Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines Palmoplantar keratosis; or keratoderma climactericum Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial Psoriasis affecting palms and soles; or body surface area for psoriasis ≥10% Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum Pityriasis rubra pilaris Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis ≥10% Active extensive verruca vulgaris, as per investigator's discretion Active fungal infection of hand and/or feet not adequately treated and responsive to antifungal therapy, as per investigator's discretion. Any clinically relevant respiratory infection within 4 weeks prior Visit 2. Any acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2. Positive serological tests for hepatitis B, hepatitis C (also confirmed with ( Hepatitis C Virus ribonucleic acid test (HCV RNA))), or human immunodeficiency virus (HIV) infection, or known infection status at Visit 2. (The test results will be available after randomisation. In case the results no longer satisfy the entry criteria, these patients will be discontinued.) Any new evidence of a concomitant disease, such as Papillon-Lefèvre Syndrome (PLS), relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the trial. Received any live attenuated vaccine within 4 weeks prior to Visit 1. Further exclusion criteria apply

Sites / Locations

  • Newport Native MD, IncRecruiting
  • University of Texas Health Science Center at TylerRecruiting
  • Medical Center ReSpiro LtdRecruiting
  • IUCPQ (Laval University)Recruiting
  • Odense University HospitalRecruiting
  • KLB Gesundheitsforschung Lübeck GmbHRecruiting
  • SMG-SNU Boramae Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BI 1291583 low dose arm

BI 1291583 medium dose arm

BI 1291583 high dose arm

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
A pulmonary exacerbation in this trial is defined as having three or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (oral or intravenous): Increased cough Increased sputum volume or change in sputum consistency Increased sputum purulence Increased breathlessness and/or decreased exercise tolerance Fatigue and/or malaise Hemoptysis
Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial

Full Information

First Posted
April 26, 2023
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05846230
Brief Title
Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine
Official Title
A Randomised, Double-blind, Parallel Group, Roll-over Study Evaluating Long-term Safety and Efficacy of Oral Doses of BI 1291583 q.d. in Patients With Bronchiectasis ((Clairleafᵀᴹ)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
March 2, 2026 (Anticipated)
Study Completion Date
March 30, 2026 (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 bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the Airleafᵀᴹ study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI 1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the Airleafᵀᴹ study continue to take the same dose. Participants visit the study site 9 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
BI 1291583 low dose arm
Arm Type
Experimental
Arm Title
BI 1291583 medium dose arm
Arm Type
Experimental
Arm Title
BI 1291583 high dose arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 1291583
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo matching BI 1291583
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Occurrence of treatment-emergent adverse events (TEAEs)
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
Description
A pulmonary exacerbation in this trial is defined as having three or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (oral or intravenous): Increased cough Increased sputum volume or change in sputum consistency Increased sputum purulence Increased breathlessness and/or decreased exercise tolerance Fatigue and/or malaise Hemoptysis
Time Frame
up to 12 months
Title
Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who completed the treatment period in Phase II trials (1397-0012) as planned per protocol. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information. Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation. Exclusion Criteria: Laboratory and medical examination 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 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then). Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then). An absolute blood neutrophil count <1,000/mm^3 (equivalent to <1,000 cells/μL or <10^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then). Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the lab tests, if no more than 6 weeks passed since then), that in the opinion of the investigator may put the patient at risk by participating in the trial. New concomitant diagnosis and therapy A new diagnosis of Hypogammaglobulinemia Common variable immunodeficiency α1-antitrypsin deficiency being treated augmentation therapy Allergic bronchopulmonary aspergillosis being treated or requiring treatment Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines Palmoplantar keratosis; or keratoderma climactericum Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial Psoriasis affecting palms and soles; or body surface area for psoriasis ≥10% Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum Pityriasis rubra pilaris Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis ≥10% Active extensive verruca vulgaris, as per investigator's discretion Active fungal infection of hand and/or feet not adequately treated and responsive to antifungal therapy, as per investigator's discretion. Any clinically relevant respiratory infection within 4 weeks prior Visit 2. Any acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2. Positive serological tests for hepatitis B, hepatitis C (also confirmed with ( Hepatitis C Virus ribonucleic acid test (HCV RNA))), or human immunodeficiency virus (HIV) infection, or known infection status at Visit 2. (The test results will be available after randomisation. In case the results no longer satisfy the entry criteria, these patients will be discontinued.) Any new evidence of a concomitant disease, such as Papillon-Lefèvre Syndrome (PLS), relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the trial. Received any live attenuated vaccine within 4 weeks prior to Visit 1. 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
Facility Information:
Facility Name
Newport Native MD, Inc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Medical Center ReSpiro Ltd
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
024903378
Email
balgariya@bitrialsupport.com
Facility Name
IUCPQ (Laval University)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80711822
Email
danmark@bitrialsupport.com
Facility Name
KLB Gesundheitsforschung Lübeck GmbH
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0808802084
Email
namhan@bitrialsupport.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
http://mystudywindow.com
Description
Related Info

Learn more about this trial

Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine

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