Clinical trial NCT06335303: A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Randomised, Double-blind, Placebo-controlled, Dose-finding Study Evaluating Efficacy, Safety, and Tolerability of Different Oral Doses of BI 1819479 Over at Least 24 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 319
Sex: ALL
Minimum age (years): 40
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 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.

Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.

At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥40 years old at the time of signed informed consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
4. On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not on treatment with either nintedanib or pirfenidone for at least 12 weeks
5. Forced Vital Capacity (FVC) ≥45% of predicted normal.
6. Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
7. Women of childbearing potential (WOCBP) must use highly effective methods of birth control with low user dependency and additional barrier contraception for male partners (use of condom) until end of follow-up period.
8. Male trial participants with WOCBP partners must use contraception (condom) to avoid exposure via seminal fluid. Female partners of male trial participants must use highly effective methods of contraception during treatment until end of follow-up period.

Exclusion Criteria:

1. Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within at least 12 weeks prior to screening and/or during the screening period (investigator-determined).
2. Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone \>15 mg/day or equivalent for respiratory or pulmonary reasons.
3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
4. The patient is currently enrolled in another investigational device or drug trial, or their Visit 1 occurs less than 30 days or 5 half-lives (whichever is longer) after completing a previous investigational device or drug trial or receiving other investigational treatments.
5. Patients with a significant disease or condition other than the IPF under study, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with trial procedures, or cause concern regarding the patient's ability to participate in the trial or any medical condition which could lead to a life expectancy \<12 months.
6. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.7).
7. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
8. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.

Further exclusion criteria apply.

Primary outcomes:
measure: Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year]
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Absolute change from baseline in FVC at Week 24 [in milliLiter]
timeFrame: At baseline and at week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lakewood
country: United States
facility: Critical Care, Pulmonary and Sleep Associates
state: Colorado
city: Kissimmee
country: United States
facility: Clinical Research Specialists LLC
state: Florida
city: Pensacola
country: United States
facility: SEC Clinical Research
state: Florida
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Warren
country: United States
facility: Advanced Pulmonary Research
state: Michigan
city: Gulfport
country: United States
facility: Memorial Hospital Gulfport
state: Mississippi
city: New Bern
country: United States
facility: Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center-Winston Salem-69289
state: North Carolina
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee, LLC
state: Tennessee
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: C.a.b.a
country: Argentina
facility: Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Caba
country: Argentina
facility: Centro de Investigación Clinica Belgrano
city: Caba
country: Argentina
facility: CEDIC - Centro de Investigacion Clinica
city: Capital Federal
country: Argentina
facility: Consultorios Médicos del Buen Ayre
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Launceston
country: Australia
facility: Launceston Respiratory & Sleep Centre
state: Tasmania
city: Footscray
country: Australia
facility: Lung Research Victoria
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Institute for Respiratory Health
state: Western Australia
city: Macquarie Park
country: Australia
facility: Macquarie University
city: Graz
country: Austria
facility: Medical University of Graz State Hospital - University Hospital Graz
city: Krems
country: Austria
facility: Krems University Hospital
city: Linz
country: Austria
facility: Kepler Univ. Klinikum Linz
city: Linz
country: Austria
facility: Hospital Elisabethinen Linz
city: Vienna
country: Austria
facility: Standort Penzing der Klinik Ottakring
city: Vienna
country: Austria
facility: Clinic Floridsdorf
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Liège
country: Belgium
facility: Liège - HOSP CHR de la Citadelle
city: Barra Mansa
country: Brazil
facility: Serviços Medicos Respirar Sul Fluminense
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - UNESP
city: Goiania
country: Brazil
facility: Hospital das Clínicas da UFG - EBSERH
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Santo André
country: Brazil
facility: Pesquisare
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: SJC
country: Brazil
facility: COE Sao Jose dos Campos
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital Of Central South University
city: Chengdu
country: China
facility: West China Hospital
city: Chengdu
country: China
facility: People's Hospital of Sichuan Province
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Hangzhou
country: China
facility: Zhejiang Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shenyang
country: China
facility: China Shenyang Chest Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
city: Xuzhou
country: China
facility: Affiliated Hospital, Xuzhou Medical college
city: Prague
country: Czechia
facility: Thomayer University Hospital
city: Prague
country: Czechia
facility: University Hospital Bulovka
city: København Ø
country: Denmark
facility: Rigshospitalet-København Ø-69883
city: Odense
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien tutkimusyksikkö
city: Oulu
country: Finland
facility: Oulun yliopistollinen keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: TYKS
city: Angers
country: France
facility: HOP d'Angers
city: Bobigny
country: France
facility: HOP Avicenne
city: Bron
country: France
facility: HOP Louis Pradel
city: Caen
country: France
facility: HOP CHU Caen
city: Lille
country: France
facility: INS Coeur Poumon
city: Marseille
country: France
facility: HOP Nord
city: Nice
country: France
facility: HOP Pasteur
city: Rennes
country: France
facility: HOP Pontchaillou
city: Rouen
country: France
facility: HOP Charles Nicolle
city: Bad Homburg
country: Germany
facility: Pneumologische Praxis Dr. Löh
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Donaustauf
country: Germany
facility: Caritas-Krankenhaus St. Maria gGmbH
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hannover
country: Germany
facility: Klinikum Region Hannover GmbH
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Leipzig
country: Germany
facility: Universität Leipzig
city: München
country: Germany
facility: Klinikum der Universität München AÖR
city: Ioannina
country: Greece
facility: Univ. Gen. Hosp. of Ioannina
city: Patras
country: Greece
facility: Univ. Gen. Hosp. of Patras
city: Voutes
country: Greece
facility: Hospital of Heraklion (PAGNI)
city: Debrecen
country: Hungary
facility: University of Debrecen Clinical Centre
city: Firenze
country: Italy
facility: A. O. Universitaria Careggi
city: Foggia
country: Italy
facility: Ospedale Colonnello D Avanzo
city: Forli'
country: Italy
facility: Ospedale G.B. Morgagni
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Milano
country: Italy
facility: Ospedale Classificato San Giuseppe
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
city: Aichi, Seto
country: Japan
facility: Tosei General Hospital
city: Fukui, Yoshida-gun
country: Japan
facility: University of Fukui Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Osaka, Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Tokushima, Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo, Mitaka
country: Japan
facility: Kyorin University Hospital
city: Tokyo, Ota-ku
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo, Shinjuku-ku
country: Japan
facility: National Center for Global Health and Medicine
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kajang
country: Malaysia
facility: Hospital Sultan Idris Shah Serdang
city: Kuala Lumpur
country: Malaysia
facility: Institut Perubatan Respiratori
city: Kuching, Sarawak
country: Malaysia
facility: Sarawak General Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: One Tree Hill, Auckland
country: New Zealand
facility: Greenlane Clinical Centre
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus HF
city: Poznan
country: Poland
facility: Clin.Hosp.Med.Univ.Marcinkowski in Poznan
city: Swidnik
country: Poland
facility: Alergopneuma Medical Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Galdakao
country: Spain
facility: Hospital de Galdakao
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: TaoYuan
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Cottingham, Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital, Wonford
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
References: