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

NCT05846230 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 1397-00172023-503290-38-00U1111-1292-0921
• Study Type: interventional
• Target: 268
• Locations: 22 countries
• Sites: 102

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 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

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment-emergent adverse events (TEAEs)

  up to 12 months

Secondary Outcomes (2)

• Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial

  up to 12 months

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

  up to 12 months

Study Arms (3)

BI 1291583 low dose arm

EXPERIMENTAL

Drug: BI 1291583; Drug: Placebo matching BI 1291583

BI 1291583 medium dose arm

EXPERIMENTAL

Drug: BI 1291583; Drug: Placebo matching BI 1291583

BI 1291583 high dose arm

EXPERIMENTAL

Drug: BI 1291583; Drug: Placebo matching BI 1291583

Interventions

BI 1291583 DRUG

Tablet

Also known as: Verducatib

BI 1291583 high dose arm; BI 1291583 low dose arm; BI 1291583 medium dose arm

Placebo matching BI 1291583 DRUG

Tablet

BI 1291583 high dose arm; BI 1291583 low dose arm; BI 1291583 medium dose arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (102)

Newport Native MD, Inc

Newport Beach, California, 92663, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

University of Florida Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Metroplex Pulmonary & Sleep Center

McKinney, Texas, 75069, United States

Location

IMA Clinical Research San Antonio

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Lung Research Queensland

Chermside, Queensland, 4032, Australia

Location

Mater Research Institute

South Brisbane, Queensland, 4101, Australia

Location

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

Location

Trialswest

Spearwood, Western Australia, 6163, Australia

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Medical Center "Zdrave-1"

Kozloduy, 3320, Bulgaria

Location

Medica Center Hera - Montana Branch

Montana, 3400, Bulgaria

Location

Medical Center ReSpiro Ltd

Razgrad, 7200, Bulgaria

Location

SHATPPD "Dr. Dimitar Gramatikov"

Rousse, 7002, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

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

Québec, G1V 4G5, Canada

Location

Pulmonary Private Practice Kralupy

Kralupy nad Vltavou, 27801, Czechia

Location

The First Pulmonary Private Practice

Prague, 19000, Czechia

Location

Aalborg Sygehus Syd

Aalborg, 9000, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Copenhagen University Hospital, Rigshospitalet

København Ø, 2100, Denmark

Location

Odense University Hospital

Odense, 5000 C, Denmark

Location

Sjællands Universitetshospital

Roskilde, 4000, Denmark

Location

Vejle University Hospital

Vejle, 7100, Denmark

Location

CHU Amiens-Picardie

Amiens, 80054, France

Location

HOP Arnaud de Villeneuve

Montpellier, 34295, France

Location

HOP Pontchaillou

Rennes, 35000, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

IKF Pneumologie GmbH & Co. KG

Frankfurt, 60596, Germany

Location

Velocity Clinical Research Germany GmbH, Ahrensburg

Großhansdorf, 22927, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Klinikum Konstanz

Konstanz, 78464, Germany

Location

Velocity Clinical Research Germany GmbH, Lübeck

Lübeck, 23552, Germany

Location

Klinikum der Universität München AÖR

München, 80336, Germany

Location

Velocity Clinical Research Germany GmbH, Wiesbaden

Wiesbaden, 65189, Germany

Location

Semmelweis University

Budapest, 1083, Hungary

Location

Da Vinci Private Clinic

Pécs, 7635, Hungary

Location

Soroka Univ. Medical Center

Beersheba, 8410101, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

Location

Hadassah Medical Center, Ein-Karem

Jerusalem, 9112001, Israel

Location

Sourasky Medical Center

Tel Aviv, 6093246, Israel

Location

Azienda Ospedaliera Meyer

Florence, 50139, Italy

Location

Policlinico "Paolo Giaccone"

Palermo, 90127, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Nagoya University Hospital

Aichi, Nagoya, 466-8560, Japan

Location

Hirosaki University Hospital

Aomori, Hirosaki, 036-8563, Japan

Location

Kameda Clinic

Chiba, Kamogawa, 296-0041, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, 319-1113, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima, 890-8520, Japan

Location

Matsusaka City Hospital

Mie, Matsusaka, 515-8544, Japan

Location

Osaka Toneyama Medical Center

Osaka, Toyonaka, 560-8552, Japan

Location

Saga University Hospital

Saga, Saga, 849-8501, Japan

Location

Fukujuji Hospital

Tokyo, Kiyose, 204-8522, Japan

Location

Kitasato Institute Hospital

Tokyo, Minato-ku, 108-8642, Japan

Location

Med.Center OLVI Health Center Assotiation,Private Practice

Daugavpils, 5410, Latvia

Location

Daugavpils Regional Hospital LTD Centre Outpatient Clinic

Daugavpils, 5417, Latvia

Location

VCA Dubultu Medical center

Jūrmala, 2015, Latvia

Location

Riga 1st Hospital

Riga, 1001, Latvia

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

LUMPII Doctors practice

Riga, 1011, Latvia

Location

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

Chihuahua City, 31203, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

Hospital Universitario Nuevo de Nuevo León - CEPREP

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

Location

Oaxaca Site Management Organization, S.C.

Oaxaca City, 68000, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, 54055, Mexico

Location

Amsterdam UMC, location VUMC

Amsterdam, 1081 HV, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 EA, Netherlands

Location

Gelre Ziekenhuis Zutphen

Zutphen, 7207 EA, Netherlands

Location

Respiratory Medicine Centre, private prac., Bialystok

Bialystok, 15044, Poland

Location

Screenmed Sp. z o.o.

Piaseczno, 05500, Poland

Location

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

Świdnik, 21040, Poland

Location

Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski

Warsaw, 01-456, Poland

Location

Dr. Piotr Napora, Center of Clinical Research

Wroclaw, 51162, Poland

Location

ULS de Santa Maria, E.P.E

Lisbon, 1649-035, Portugal

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07071, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

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

Seoul, 22711, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital de Mérida

Mérida, 06800, Spain

Location

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, 34890, Turkey (Türkiye)

Location

Ninewells Hospital & Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39175217 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

BU (5); CA (2); CZ (2); JP (11); KR (5); ME (5); DK (6); IT (5); ES (5); GB (1); BE (2); AU (6); TU (1); US (11); FR (3); DE (11); NL (3); IL (4); PL (5); PT (1); LA (6); HU (2)