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New daily pill aims to tame chronic lung inflammation in bronchiectasis

NCT ID NCT05846230

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 8 times

Summary

This study tests a daily tablet called BI 1291583 (Verducatib) in 268 adults with bronchiectasis, a long-term lung condition. Participants who were in earlier trials continue or switch to the drug for up to one year. The main goal is to check safety and see if the drug reduces lung flare-ups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 1291583 (Verducatib)
What this could lead to
If it works, this could provide a new daily pill to reduce lung inflammation and flare-ups in people with bronchiectasis.
What could go wrong
This is a mid-stage trial with no placebo comparison for most participants, so results may not prove clear benefit. Long-term safety is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

268 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiectasis

Contacts and locations

Locations

  • Aalborg Sygehus Syd

    Aalborg, 9000, Denmark

  • Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski

    Warsaw, 01-456, Poland

  • Amsterdam UMC, location VUMC

    Amsterdam, 1081 HV, Netherlands

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Meyer

    Florence, 50139, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • CHU Amiens-Picardie

    Amiens, 80054, France

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

    Montreal, Quebec, H2X 0A9, Canada

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055, Mexico

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100, Denmark

  • Da Vinci Private Clinic

    Pécs, 7635, Hungary

  • Daugavpils regionala slimnica SIA

    Daugavpils, 5417, Latvia

  • Dr. Piotr Napora, Center of Clinical Research

    Wroclaw, 51162, Poland

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100, Italy

  • Fukujuji Hospital

    Tokyo, Kiyose, 204-8522, Japan

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 EA, Netherlands

  • HOP Arnaud de Villeneuve

    Montpellier, 34295, France

  • HOP Pontchaillou

    Rennes, 35000, France

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001, Israel

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563, Japan

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Hospital Universitario Nuevo de Nuevo León - CEPREP

    Monterrey, Nuevo León, C.P. 64460, Mexico

  • Hospital de Mérida

    Mérida, 06800, Spain

  • Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596, Germany

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • Ibarakihigashi National Hospial

    Ibaraki, Naka-gun, 319-1113, Japan

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

    Québec, G1V 4G5, Canada

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009, Australia

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089, Italy

  • Kagoshima University Hospital

    Kagoshima, Kagoshima, 890-8520, Japan

  • Kameda Clinic

    Chiba, Kamogawa, 296-0041, Japan

  • Kitasato Institute Hospital

    Tokyo, Minato-ku, 108-8642, Japan

  • Klinikum Konstanz

    Konstanz, 78464, Germany

  • Klinikum der Universität München AÖR

    München, 80336, Germany

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Lady Davis Carmel Medical Center

    Haifa, 3436212, Israel

  • Lung Research Queensland

    Chermside, Queensland, 4032, Australia

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Macquarie University

    Macquarie Park, New South Wales, 2109, Australia

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608, United States

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890, Turkey (Türkiye)

  • Mater Research Institute

    South Brisbane, Queensland, 4101, Australia

  • Matsusaka City Hospital

    Mie, Matsusaka, 515-8544, Japan

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

    Chihuahua City, 31203, Mexico

  • Medical Center Hera - Montana Branch

    Montana, 3400, Bulgaria

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center ReSpiro Ltd

    Razgrad, 7200, Bulgaria

  • Medical Center Zdrave-1 OOD

    Kozloduy, 3320, Bulgaria

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mediciniskas pecdiploma izglitibas instituts SIA

    Riga, 1011, Latvia

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069, United States

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560, Japan

  • New York University Langone Medical Center

    New York, New York, 10016, United States

  • Newport Native MD, Inc

    Newport Beach, California, 92663, United States

  • Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY, United Kingdom

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000, Mexico

  • Odense University Hospital

    Odense, 5000 C, Denmark

  • Osaka Toneyama Medical Center

    Osaka, Toyonaka, 560-8552, Japan

  • Pauls Stradins Clinical University Hospital

    Riga, 1002, Latvia

  • Policlinico "Paolo Giaccone"

    Palermo, 90127, Italy

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

    Świdnik, 21040, Poland

  • Pulmonary Private Practice Kralupy

    Kralupy nad Vltavou, 27801, Czechia

  • Respiratory Medicine Centre, private prac., Bialystok

    Bialystok, 15044, Poland

  • Rigas 1. slimnica SIA

    Riga, 1001, Latvia

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239, Germany

  • SHATPPD "Dr. Dimitar Gramatikov"

    Rousse, 7002, Bulgaria

  • SMG-SNU Boramae Medical Center

    Seoul, 07071, South Korea

  • Saga University Hospital

    Saga, Saga, 849-8501, Japan

  • Screenmed Sp. z o.o.

    Piaseczno, 05500, Poland

  • Semmelweis University

    Budapest, 1083, Hungary

  • Sjællands Universitetshospital

    Roskilde, 4000, Denmark

  • Soroka Univ. Medical Center

    Beersheba, 8410101, Israel

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

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

    Seoul, 22711, South Korea

  • The First Pulmonary Private Practice

    Prague, 19000, Czechia

  • Trialswest

    Spearwood, Western Australia, 6163, Australia

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035, Portugal

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 EA, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University of California Davis

    Sacramento, California, 95817, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • Universitätsklinikum Jena

    Jena, 07747, Germany

  • VCA Dubultu Medical center

    Jūrmala, 2015, Latvia

  • Vejle University Hospital

    Vejle, 7100, Denmark

  • Velocity Clinical Research Germany GmbH, Ahrensburg

    Großhansdorf, 22927, Germany

  • Velocity Clinical Research Germany GmbH, Lübeck

    Lübeck, 23552, Germany

  • Velocity Clinical Research Germany GmbH, Wiesbaden

    Wiesbaden, 65189, Germany

  • Veselibas centru apvieniba AS

    Daugavpils, 5410, Latvia

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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