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ACTIVE NOT RECRUITING

NCT05846230

PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

268

Start Date

2023-09-08

Completion Date

2027-03-31

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Bronchiectasis

Interventions

DRUG

BI 1291583

Tablet

DRUG

Placebo matching BI 1291583

Tablet

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

Locations (102)

Newport Native MD, Inc

Newport Beach, California, United States

University of California Davis

Sacramento, California, United States

Malcom Randall VA Medical Center

Gainesville, Florida, United States

University of Florida Health Jacksonville

Jacksonville, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

New York University Langone Medical Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Macquarie University

Macquarie Park, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Lung Research Queensland

Chermside, Queensland, Australia

Mater Research Institute

South Brisbane, Queensland, Australia

Institute for Respiratory Health

Nedlands, Western Australia, Australia

Trialswest

Spearwood, Western Australia, Australia

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Medical Center "Zdrave-1"

Kozloduy, Bulgaria

Medica Center Hera - Montana Branch

Montana, Bulgaria

Medical Center ReSpiro Ltd

Razgrad, Bulgaria

SHATPPD "Dr. Dimitar Gramatikov"

Rousse, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

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

Québec, Canada

Pulmonary Private Practice Kralupy

Kralupy nad Vltavou, Czechia

The First Pulmonary Private Practice

Prague, Czechia

Aalborg Sygehus Syd

Aalborg, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Copenhagen University Hospital, Rigshospitalet

København Ø, Denmark

Odense University Hospital

Odense, Denmark

Sjællands Universitetshospital

Roskilde, Denmark

Vejle University Hospital

Vejle, Denmark

CHU Amiens-Picardie

Amiens, France

HOP Arnaud de Villeneuve

Montpellier, France

HOP Pontchaillou

Rennes, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, Germany

IKF Pneumologie GmbH & Co. KG

Frankfurt, Germany

Velocity Clinical Research Germany GmbH, Ahrensburg

Großhansdorf, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Universitätsklinikum Jena

Jena, Germany

Klinikum Konstanz

Konstanz, Germany

Velocity Clinical Research Germany GmbH, Lübeck

Lübeck, Germany

Klinikum der Universität München AÖR

München, Germany

Velocity Clinical Research Germany GmbH, Wiesbaden

Wiesbaden, Germany

Semmelweis University

Budapest, Hungary

Da Vinci Private Clinic

Pécs, Hungary

Soroka Univ. Medical Center

Beersheba, Israel

Lady Davis Carmel Medical Center

Haifa, Israel

Hadassah Medical Center, Ein-Karem

Jerusalem, Israel

Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Meyer

Florence, Italy

Policlinico "Paolo Giaccone"

Palermo, Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Istituto Clinico Humanitas

Rozzano (MI), Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Nagoya University Hospital

Aichi, Nagoya, Japan

Hirosaki University Hospital

Aomori, Hirosaki, Japan

Kameda Clinic

Chiba, Kamogawa, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima, Japan

Matsusaka City Hospital

Mie, Matsusaka, Japan

Osaka Toneyama Medical Center

Osaka, Toyonaka, Japan

Saga University Hospital

Saga, Saga, Japan

Fukujuji Hospital

Tokyo, Kiyose, Japan

Kitasato Institute Hospital

Tokyo, Minato-ku, Japan

Med.Center OLVI Health Center Assotiation,Private Practice

Daugavpils, Latvia

Daugavpils Regional Hospital LTD Centre Outpatient Clinic

Daugavpils, Latvia

VCA Dubultu Medical center

Jūrmala, Latvia

Riga 1st Hospital

Riga, Latvia

Pauls Stradins Clinical University Hospital

Riga, Latvia

LUMPII Doctors practice

Riga, Latvia

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

Chihuahua City, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Mexico

Hospital Universitario Nuevo de Nuevo León - CEPREP

Monterrey, Nuevo León, Mexico

Oaxaca Site Management Organization, S.C.

Oaxaca City, Mexico

Clinical Research Institute S.C.

Tlalnepantla, Mexico

Amsterdam UMC, location VUMC

Amsterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Gelre Ziekenhuis Zutphen

Zutphen, Netherlands

Respiratory Medicine Centre, private prac., Bialystok

Bialystok, Poland

Screenmed Sp. z o.o.

Piaseczno, Poland

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

Świdnik, Poland

Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski

Warsaw, Poland

Dr. Piotr Napora, Center of Clinical Research

Wroclaw, Poland

ULS de Santa Maria, E.P.E

Lisbon, Portugal

Chungbuk National University Hospital

Cheongju-si, South Korea

Asan Medical Center

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

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

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital de Mérida

Mérida, Spain

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Ninewells Hospital & Medical School

Dundee, Scotland, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (102)