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

Bronchiectasis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846230
• Other study ID #: 1397-0017
• Secondary ID: 2023-503290-38-0
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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 study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI 1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the Airleafᵀᴹ study continue to take the same dose.

Participants visit the study site 9 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 30, 2026
• Est. primary completion date: March 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who completed the treatment period in Phase II trials (1397-0012) 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. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.

• 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

• a1-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.

• 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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• BI 1291583
Tablet
• Placebo matching BI 1291583
Tablet

Locations

Country	Name	City	State
Australia	Lung Research Queensland	Chermside	Queensland
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	Institute for Respiratory Health	Nedlands	Western Australia
Australia	Mater Research Institute	South Brisbane	Queensland
Australia	Trialswest	Spearwood	Western Australia
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	UNIV UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Bulgaria	Medical Center "Zdrave-1"	Kozloduy
Bulgaria	Medica Center Hera - Montana Branch	Montana
Bulgaria	Medical Center ReSpiro Ltd	Razgrad
Bulgaria	Medical Center Hera EOOD	Sofia
Canada	IUCPQ (Laval University)	Quebec
Czechia	Pulmonary Private Practice Kralupy	Kralupy nad Vltavou
Czechia	The First Pulmonary Private Practice	Prague 9
Denmark	Aalborg Sygehus Syd	Ålborg
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
France	HOP Amiens-Picardie Sud	Amiens
France	HOP Arnaud de Villeneuve	Montpellier
France	HOP Pontchaillou	Rennes
Germany	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	Großhansdorf
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Klinikum Konstanz	Konstanz
Germany	Velocity Clinical Research Germany GmbH	Lübeck
Germany	Klinikum der Universität München AÖR	München
Germany	Velocity Clinical Research Germany GmbH	Wiesbaden
Hungary	Da Vinci Private Clinic	Pecs
Italy	A.O. Univ. Policlinico "Paolo Giaccone"	Palermo
Italy	Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Japan	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
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Latvia	Med.Center OLVI Health Center Assotiation,Private Practice	Daugavpils
Latvia	VCA Dubultu Medical center	Jurmala
Latvia	LUMPII Doctors practice	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga 1st Hospital	Riga
Mexico	Hospital Universitario Nuevo de Nuevo León - CEPREP	Monterrey, Nuevo León
Netherlands	Amsterdam UMC, Locatie AMC	Amsterdam
Netherlands	Gelre Ziekenhuis Zutphen	Zutphen
Poland	Respiratory Medicine Centre, private prac., Bialystok	Bialystok
Poland	Screenmed Sp. z o.o.	Piaseczno
Poland	Alergopneuma Medical Center	Swidnik
Poland	Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski	Warszawa
Poland	Dr. Piotr Napora, Center of Clinical Research	Wroclaw
Portugal	ULS de Santa Maria, E.P.E	Lisboa
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de Bellvitge	L'Hospitalet de Llobregat
Spain	Hospital de Mérida	Mérida
Spain	Hospital Quirónsalud Madrid	Pozuelo de Alarcón
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi	Istanbul
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati	Cincinnati	Ohio
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	Metroplex Pulmonary & Sleep Center	McKinney	Texas
United States	New York University Langone Medical Center	New York	New York
United States	Newport Native MD, Inc	Newport Beach	California
United States	University of California Davis	Sacramento	California
United States	IMA Clinical Research San Antonio	San Antonio	Texas
United States	University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Netherlands,  Poland,  Portugal,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of treatment-emergent adverse events (TEAEs)		up to 12 months
Secondary	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	up to 12 months
Secondary	Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial		up to 12 months

External Links

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