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BronchiectasisPhase 2NCT05846230

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

A Phase 2 study testing BI 1291583 in people with Bronchiectasis, run by Boehringer Ingelheim at 103 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 or 1397-0013 Clairaflyᵀᴹ). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchiectasis
What is being tested?
BI 1291583
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
268 participants
Where
103 sitesin 22 countries
Study dates
8 Sep 2023to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

103 sites in 22 countries.

103 sites in 22 countries

United States11 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069

  • New York University Langone Medical Center

    New York, New York, 10016

  • Newport Native MD, Inc

    Newport Beach, California, 92663

  • University of California Davis

    Sacramento, California, 95817

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

Other trials in United States

Germany11 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596

  • Velocity Clinical Research Germany GmbH, Ahrensburg

    Großhansdorf, 22927

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Universitätsklinikum Jena

    Jena, 07747

  • Klinikum Konstanz

    Konstanz, 78464

  • Velocity Clinical Research Germany GmbH, Lübeck

    Lübeck, 23552

  • Klinikum der Universität München AÖR

    München, 80336

  • Velocity Clinical Research Germany GmbH, Wiesbaden

    Wiesbaden, 65189

Other trials in Germany

Japan11 sites

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563

  • Kameda Clinic

    Chiba, Kamogawa, 296-0041

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Ibarakihigashi National Hospial

    Ibaraki, Naka-gun, 319-1113

  • Kagoshima University Hospital

    Kagoshima, Kagoshima, 890-8520

  • Matsusaka City Hospital

    Mie, Matsusaka, 515-8544

  • Osaka Toneyama Medical Center

    Osaka, Toyonaka, 560-8552

  • Saga University Hospital

    Saga, Saga, 849-8501

  • Fukujuji Hospital

    Tokyo, Kiyose, 204-8522

  • Kitasato Institute Hospital

    Tokyo, Minato-ku, 108-8642

Other trials in Japan

Australia6 sites

  • Lung Research Queensland

    Chermside, Queensland, 4032

  • Macquarie University

    Macquarie Park, New South Wales, 2109

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

  • Mater Research Institute

    South Brisbane, Queensland, 4101

  • Trialswest

    Spearwood, Western Australia, 6163

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Denmark6 sites

  • Aalborg Sygehus Syd

    Aalborg, 9000

  • Hvidovre Hospital

    Hvidovre, 2650

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100

  • Odense University Hospital

    Odense, 5000 C

  • Sjællands Universitetshospital

    Roskilde, 4000

  • Vejle University Hospital

    Vejle, 7100

Other trials in Denmark

Latvia6 sites

  • Veselibas centru apvieniba AS

    Daugavpils, 5410

  • Daugavpils regionala slimnica SIA

    Daugavpils, 5417

  • VCA Dubultu Medical center

    Jūrmala, 2015

  • Rigas 1. slimnica SIA

    Riga, 1001

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Mediciniskas pecdiploma izglitibas instituts SIA

    Riga, 1011

Other trials in Latvia

Bulgaria5 sites

  • Medical Center Zdrave-1 OOD

    Kozloduy, 3320

  • Medical Center Hera - Montana Branch

    Montana, 3400

  • Medical Center ReSpiro Ltd

    Razgrad, 7200

  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse

    Rousse, 7002

  • Medical Center Hera EOOD

    Sofia, 1510

Other trials in Bulgaria

Italy5 sites

  • Azienda Ospedaliera Meyer

    Florence, 50139

  • Policlinico "Paolo Giaccone"

    Palermo, 90127

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Mexico5 sites

  • Mediadvance Clinical S.A.P.I de C.V.

    Chihuahua City, 31203

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Hospital Universitario Nuevo de Nuevo León - CEPREP

    Monterrey, Nuevo León, C.P. 64460

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

Other trials in Mexico

Poland5 sites

  • Respiratory Medicine Centre, private prac., Bialystok

    Bialystok, 15044

  • Screenmed Sp. z o.o.

    Piaseczno, 05500

  • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.

    Świdnik, 21040

  • Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski

    Warsaw, 01-456

  • Dr. Piotr Napora, Center of Clinical Research

    Wroclaw, 51162

Other trials in Poland

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Asan Medical Center

    Seoul, 05505

  • SMG-SNU Boramae Medical Center

    Seoul, 07071

  • Korea University Guro Hospital

    Seoul, 08308

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 22711

Other trials in South Korea

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital de Mérida

    Mérida, 06800

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

Israel4 sites

  • Soroka Univ. Medical Center

    Beersheba, 8410101

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

France3 sites

  • CHU Amiens-Picardie

    Amiens, 80054

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Pontchaillou

    Rennes, 35000

Other trials in France

Netherlands3 sites

  • Amsterdam UMC, location VUMC

    Amsterdam, 1081 HV

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 EA

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 EA

Other trials in Netherlands

Belgium2 sites

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Canada2 sites

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

    Québec, G1V 4G5

Other trials in Canada

Czechia2 sites

  • Pulmonary Private Practice Kralupy

    Kralupy nad Vltavou, 27801

  • The First Pulmonary Private Practice

    Prague, 19000

Other trials in Czechia

Hungary2 sites

  • Semmelweis University

    Budapest, 1083

  • Da Vinci Private Clinic

    Pécs, 7635

Other trials in Hungary

Turkey (Türkiye)2 sites

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890

  • Sureyyapasa Egitim ve Arastirma Hastanesi

    Istanbul, 34890

Other trials in Turkey (Türkiye)

Portugal1 site

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035

Other trials in Portugal

United Kingdom1 site

  • Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY

Other trials in United Kingdom

About this study

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)

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.

Conditions
Bronchiectasis
Being tested
BI 1291583, Placebo matching BI 1291583
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1291583Drug

    Also called Verducatib

    Tablet

  • Placebo matching BI 1291583Drug

    Tablet

Study groups in NCT05846230
Study groupRoleWhat they receive
BI 1291583 low dose armExperimentalNot described
Receives: Drug: BI 1291583; Drug: Placebo matching BI 1291583
BI 1291583 medium dose armExperimentalNot described
Receives: Drug: BI 1291583; Drug: Placebo matching BI 1291583
BI 1291583 high dose armExperimentalNot described
Receives: Drug: BI 1291583; Drug: Placebo matching BI 1291583

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of treatment-emergent adverse events (TEAEs)

    Measured: up to 12 months

Secondary outcomes (2)

  1. 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

    Measured: up to 12 months

  2. Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start8 Sep 2023
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846230
Sponsor's protocol ID
1397-0017
Other IDs
2023-503290-38-00, U1111-1292-0921, 2023
Status last verified
Oct 2026
First submitted
26 Apr 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39175217

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 1291583 in people with Bronchiectasis, run by Boehringer Ingelheim at 103 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Germany, Japan, Australia, Denmark and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment-emergent adverse events (TEAEs) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05846230, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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