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

April 15, 2024 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Belgium
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
      • Montana, Bulgaria, 3400
      • Razgrad, Bulgaria, 7200
      • Sofia, Bulgaria, 1510
  • Canada
      • Quebec, Canada, G1V 4G5
        • Active, not recruiting
        • IUCPQ (Laval University)
  • Czechia
      • Prague 9, Czechia, 19000
        • Recruiting
        • The First Pulmonary Private Practice
        • Contact:
  • Denmark
      • Odense, Denmark, 5000 C
      • Ålborg, Denmark, 9000
  • France
      • Montpellier, France, 34295
        • Recruiting
        • HOP Arnaud de Villeneuve
        • Contact:
      • Rennes, France, 35000
  • Germany
      • Essen, Germany, 45239
        • Recruiting
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Contact:
      • Frankfurt, Germany, 60596
      • Großhansdorf, Germany, 22927
      • Immenhausen, Germany, 34376
      • Konstanz, Germany, 78464
      • Lübeck, Germany, 23552
  • Hungary
  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
  • Japan
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
        • Contact:
      • Mie, Matsusaka, Japan, 515-8544
        • Active, not recruiting
        • Matsusaka City Hospital
      • Osaka, Toyonaka, Japan, 560-8552
        • Recruiting
        • Osaka Toneyama Medical Center
        • Contact:
      • Saga, Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
        • Contact:
      • Tokyo, Kiyose, Japan, 204-8522
      • Tokyo, Minato-ku, Japan, 108-8642
        • Recruiting
        • Kitasato Institute Hospital
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
  • Latvia
      • Riga, Latvia, 1001
      • Riga, Latvia, 1002
        • Recruiting
        • Pauls Stradins Clinical University Hospital
        • Contact:
      • Riga, Latvia, 1011
  • Netherlands
      • Zutphen, Netherlands, 7207 EA
  • Poland
      • Piaseczno, Poland, 05500
      • Swidnik, Poland, 21040
        • Recruiting
        • Alergopneuma Medical Center
        • Contact:
      • Wroclaw, Poland, 51162
        • Recruiting
        • Dr. Piotr Napora, Center of Clinical Research
        • Contact:
  • Portugal
      • Lisboa, Portugal, 1649-035
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
      • L'Hospitalet de Llobregat, Spain, 08907
      • Pozuelo de Alarcón, Spain, 28223
        • Recruiting
        • Hospital Quirónsalud Madrid
        • Contact:
  • United States
    • California
      • Newport Beach, California, United States, 92663
    • Texas
      • McKinney, Texas, United States, 75069
      • San Antonio, Texas, United States, 78229
      • Tyler, Texas, United States, 75708
        • Recruiting
        • University of Texas Health Science Center at Tyler
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 1291583 low dose arm
Drug: BI 1291583
Tablet
Drug: Placebo matching BI 1291583
Tablet
Experimental: BI 1291583 medium dose arm
Drug: BI 1291583
Tablet
Drug: Placebo matching BI 1291583
Tablet
Experimental: BI 1291583 high dose arm
Drug: BI 1291583
Tablet
Drug: Placebo matching BI 1291583
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of treatment-emergent adverse events (TEAEs)
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
Time Frame: up to 12 months

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
up to 12 months
Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1397-0017
  • 2023-503290-38-00 (Registry Identifier: CTIS)
  • U1111-1292-0921 (Registry Identifier: WHO Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiectasis

Clinical Trials on BI 1291583

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe