Clinical trial NCT05846230: 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
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Bronchiectasis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: up to 12 months
Secondary outcomes:
measure: Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
timeFrame: up to 12 months
measure: Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Native MD, Inc
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: McKinney
country: United States
facility: Metroplex Pulmonary & Sleep Center
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Lung Research Queensland
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Research Institute
state: Queensland
city: Nedlands
country: Australia
facility: Institute for Respiratory Health
state: Western Australia
city: Spearwood
country: Australia
facility: Trialswest
state: Western Australia
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Kozloduy
country: Bulgaria
facility: Medical Center "Zdrave-1"
city: Montana
country: Bulgaria
facility: Medica Center Hera - Montana Branch
city: Razgrad
country: Bulgaria
facility: Medical Center ReSpiro Ltd
city: Ruse
country: Bulgaria
facility: SHATPPD "Dr. Dimitar Gramatikov"
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Quebec
country: Canada
facility: IUCPQ (Laval University)
city: Kralupy nad Vltavou
country: Czechia
facility: Pulmonary Private Practice Kralupy
city: Prague 9
country: Czechia
facility: The First Pulmonary Private Practice
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: København Ø
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital
city: Vejle
country: Denmark
facility: Vejle University Hospital
city: Ålborg
country: Denmark
facility: Aalborg Sygehus Syd
city: Amiens
country: France
facility: HOP Amiens-Picardie Sud
city: Montpellier
country: France
facility: HOP Arnaud de Villeneuve
city: Rennes
country: France
facility: HOP Pontchaillou
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Frankfurt
country: Germany
facility: IKF Pneumologie GmbH & Co. KG
city: Großhansdorf
country: Germany
facility: Velocity Clinical Research Germany GmbH-Ahrensburg-69816
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Lübeck
country: Germany
facility: Velocity Clinical Research Germany GmbH-Lübeck-69809
city: München
country: Germany
facility: Klinikum der Universität München AÖR
city: Wiesbaden
country: Germany
facility: Velocity Clinical Research Germany GmbH-Wiesbaden-69521
city: Budapest
country: Hungary
facility: Semmelweis University
city: Pecs
country: Hungary
facility: Da Vinci Private Clinic
city: Beer Sheva
country: Israel
facility: Soroka Univ. Medical Center
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Ein-Karem
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Firenze
country: Italy
facility: Azienda Ospedaliera Meyer
city: Palermo
country: Italy
facility: Policlinico "Paolo Giaccone"
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Verona
country: Italy
facility: A.O. Univ. Integrata di Verona
city: Aichi, Nagoya
country: Japan
facility: Nagoya University Hospital
city: Aomori, Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Chiba, Kamogawa
country: Japan
facility: Kameda Clinic
city: Fukuoka, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Ibaraki, Naka-gun
country: Japan
facility: Ibarakihigashi National Hospial
city: Kagoshima, Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Mie, Matsusaka
country: Japan
facility: Matsusaka City Hospital
city: Osaka, Toyonaka
country: Japan
facility: Osaka Toneyama Medical Center
city: Saga, Saga
country: Japan
facility: Saga University Hospital
city: Tokyo, Kiyose
country: Japan
facility: Fukujuji Hospital
city: Tokyo, Minato-ku
country: Japan
facility: Kitasato Institute Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Daugavpils
country: Latvia
facility: Med.Center OLVI Health Center Assotiation,Private Practice
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital LTD Centre Outpatient Clinic
city: Jurmala
country: Latvia
facility: VCA Dubultu Medical center
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: LUMPII Doctors practice
city: Chihuahua
country: Mexico
facility: Mediadvance Clinical S.A.P.I de C.V.
city: Monterrey, Nuevo León
country: Mexico
facility: Hospital Universitario Nuevo de Nuevo León - CEPREP
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization, S.C.
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute S.C.
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUMC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuis Zutphen
city: Bialystok
country: Poland
facility: Respiratory Medicine Centre, private prac., Bialystok
city: Piaseczno
country: Poland
facility: Screenmed Sp. z o.o.
city: Swidnik
country: Poland
facility: Alergopneuma Medical Center
city: Warszawa
country: Poland
facility: Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
city: Wroclaw
country: Poland
facility: Dr. Piotr Napora, Center of Clinical Research
city: Lisboa
country: Portugal
facility: ULS de Santa Maria, E.P.E
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Mérida
country: Spain
facility: Hospital de Mérida
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Quirónsalud Madrid
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
city: Dundee, Scotland
country: United Kingdom
facility: Ninewells Hospital & Medical School
Study officials:
References: