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

August 20, 2026 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 or 1397-0013 Clairaflyᵀᴹ). 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 or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose.

Participants visit the study site 10 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

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 Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie University
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Lung Research Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Research Institute
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Institute for Respiratory Health
      • Spearwood, Western Australia, Australia, 6163
        • Trialswest
  • Belgium
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
        • Medical Center Zdrave-1 OOD
      • Montana, Bulgaria, 3400
        • Medical Center Hera - Montana Branch
      • Razgrad, Bulgaria, 7200
        • Medical Center ReSpiro Ltd
      • Rousse, Bulgaria, 7002
        • SHATPPD "Dr. Dimitar Gramatikov"
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Université de Montréal (CHUM)
  • Czechia
      • Kralupy nad Vltavou, Czechia, 27801
        • Pulmonary Private Practice Kralupy
      • Prague, Czechia, 19000
        • The First Pulmonary Private Practice
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Sygehus Syd
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • København Ø, Denmark, 2100
        • Copenhagen University Hospital, Rigshospitalet
      • Odense, Denmark, 5000 C
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Sjællands Universitetshospital
      • Vejle, Denmark, 7100
        • Vejle University Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie
      • Montpellier, France, 34295
        • HOP Arnaud de Villeneuve
      • Rennes, France, 35000
        • HOP Pontchaillou
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Essen, Germany, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Frankfurt, Germany, 60596
        • IKF Pneumologie GmbH & Co. KG
      • Großhansdorf, Germany, 22927
        • Velocity Clinical Research Germany GmbH, Ahrensburg
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Konstanz, Germany, 78464
        • Klinikum Konstanz
      • Lübeck, Germany, 23552
        • Velocity Clinical Research Germany GmbH, Lübeck
      • München, Germany, 80336
        • Klinikum der Universität München AÖR
      • Wiesbaden, Germany, 65189
        • Velocity Clinical Research Germany GmbH, Wiesbaden
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis University
      • Pécs, Hungary, 7635
        • Da Vinci Private Clinic
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Univ. Medical Center
      • Haifa, Israel, 3436212
        • Lady Davis Carmel Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center, Ein-Karem
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
  • Italy
      • Florence, Italy, 50139
        • Azienda Ospedaliera Meyer
      • Palermo, Italy, 90127
        • Policlinico "Paolo Giaccone"
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico S. Matteo
      • Rozzano (MI), Italy, 20089
        • Istituto Clinico Humanitas
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Japan
      • Aichi, Nagoya, Japan, 466-8560
        • Nagoya University Hospital
      • Aomori, Hirosaki, Japan, 036-8563
        • Hirosaki University Hospital
      • Chiba, Kamogawa, Japan, 296-0041
        • Kameda Clinic
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Ibaraki, Naka-gun, Japan, 319-1113
        • Ibarakihigashi National Hospial
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Mie, Matsusaka, Japan, 515-8544
        • Matsusaka City Hospital
      • Osaka, Toyonaka, Japan, 560-8552
        • Osaka Toneyama Medical Center
      • Saga, Saga, Japan, 849-8501
        • Saga University Hospital
      • Tokyo, Kiyose, Japan, 204-8522
        • Fukujuji Hospital
      • Tokyo, Minato-ku, Japan, 108-8642
        • Kitasato Institute Hospital
  • Latvia
      • Daugavpils, Latvia, 5410
        • Veselibas centru apvieniba AS
      • Daugavpils, Latvia, 5417
        • Daugavpils regionala slimnica SIA
      • Jūrmala, Latvia, 2015
        • VCA Dubultu Medical center
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, 1001
        • Rigas 1. slimnica SIA
      • Riga, Latvia, 1011
        • Mediciniskas pecdiploma izglitibas instituts SIA
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Mediadvance Clinical S.A.P.I de C.V.
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • Monterrey, Nuevo León, Mexico, C.P. 64460
        • Hospital Universitario Nuevo de Nuevo León - CEPREP
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization, S.C.
      • Tlalnepantla, Mexico, 54055
        • Clinical Research Institute S.C.
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC, location VUmc
      • Utrecht, Netherlands, 3584 EA
        • Universitair Medisch Centrum Utrecht
      • Zutphen, Netherlands, 7207 EA
        • Gelre Ziekenhuis Zutphen
  • Poland
      • Bialystok, Poland, 15044
        • Respiratory Medicine Centre, private prac., Bialystok
      • Piaseczno, Poland, 05500
        • Screenmed Sp. z o.o.
      • Warsaw, Poland, 01-456
        • Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
      • Wroclaw, Poland, 51162
        • Dr. Piotr Napora, Center of Clinical Research
      • Świdnik, Poland, 21040
        • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
  • Portugal
      • Lisbon, Portugal, 1649-035
        • ULS de Santa Maria, E.P.E
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Chungbuk National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 07071
        • SMG-SNU Boramae Medical Center
      • Seoul, South Korea, 22711
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • L'Hospitalet de Llobregat, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Mérida, Spain, 06800
        • Hospital de Mérida
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Quirónsalud Madrid
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34890
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  • United Kingdom
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital & Medical School
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Newport Native MD, Inc
      • Sacramento, California, United States, 95817
        • University of California Davis
    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcom Randall VA Medical Center
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health Jacksonville
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary & Sleep Center
      • San Antonio, Texas, United States, 78229
        • IMA Clinical Research San Antonio
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center at Tyler

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 or 1397-0013) 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, unless recovered in the opinion of the investigator by 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
Other Names:
  • Verducatib
Drug: Placebo matching BI 1291583
Tablet
Experimental: BI 1291583 medium dose arm
Drug: BI 1291583
Tablet
Other Names:
  • Verducatib
Drug: Placebo matching BI 1291583
Tablet
Experimental: BI 1291583 high dose arm
Drug: BI 1291583
Tablet
Other Names:
  • Verducatib
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.

General Publications

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)

September 8, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

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)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1397-0017
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 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.clinicalstudies.boehringer-ingelheim.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.

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