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NCT06335303CompletedPhase 2

A study to test whether BI 1819479 improves lung function in people with idiopathic pulmonary fibrosis (IPF).

A randomised, double-blind, placebo-controlled, dose-finding study evaluating efficacy, safety and tolerability of different doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF).

Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Feb 2026

Brief summary (registry, in English)

The primary objectives are to demonstrate a non-flat dose response curve, evaluate the quantitative treatment effect size and evaluate the dose-response relationship of 3 different doses of BI 1819479 versus placebo.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
123 (actual)
First submitted
13 May 2024
Start date
10 Sept 2024
Lead sponsor
Boehringer Ingelheim International GmbH
EU CT number
2023-508395-11-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 123
  • 75 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone >15 mg/day or equivalent for respiratory or pulmonary reasons.

Other illness

  • 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.
  • Lower respiratory tract infection requiring treatment within 4 weeks and/or during the screening period

Other

  • Acute IPF exacerbation within at least 12 weeks and/or during the screening period
  • Relevant airways obstruction (pre-bronchodilator FEV1/FVC <0.7).
  • In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  • Further exclusion criteria apply.

Who the study is looking for

  • Patients ≥40 years old at the time of signed informed consent.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guidelines
  • 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
  • Forced Vital Capacity (FVC) ≥45% of predicted normal.
  • DLCO ≥25% of predicted normal corrected for hemoglobin (Hb).
  • 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.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (75)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaCompleted
Universitaetsklinikum Krems
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Krems An Der DonauAustriaCompleted
Johannes Kepler University Linz
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LinzAustriaCompleted
Ordensklinikum Linz GmbH
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LinzAustriaCompleted
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaCompleted
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaCompleted
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumCompleted
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Fakultni nemocnice Bulovka
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PragueCzechiaCompleted
Fakultni Thomayerova nemocnice
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Prague 4CzechiaCompleted
Pneumologische Praxis Dr. Löh
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Bad HomburgGermanyCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyCompleted
Caritas-Krankenhaus St. Maria gGmbH
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DonaustaufGermanyCompleted
Klinikum Fulda gAG
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FuldaGermanyCompleted
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyCompleted
Klinikum Region Hannover GmbH
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HanoverGermanyCompleted
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
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HemerGermanyCompleted
Lungenfachklinik Immenhausen
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ImmenhausenGermanyCompleted
Klinikum Konstanz GmbH
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KonstanzGermanyCompleted
Universitaet Leipzig
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LeipzigGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital de Galdakao-Usansolo
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GaldakaoSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario de la Princesa
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MadridSpainCompleted
Hospital Universitario Infanta Leonor
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
HUS-Yhtymae
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HelsinkiFinlandCompleted
Kuopio University Hospital
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KuopioFinlandCompleted
Pohjois-Pohjanmaan hyvinvointialue
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OuluFinlandCompleted
Tampere University Hospital
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Assistance Publique Hopitaux De Paris
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BobignyFranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyCompleted
Azienda Unita Sanitaria Locale Della Romagna
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Forli'ItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Multimedica S.p.A.
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MilanItalyCompleted
Azienda Ospedaliera di Padova
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PadovaItalyCompleted
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Helse Bergen HF
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BergenNorwayCompleted
Akershus University Hospital
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LorenskogNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
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ŚwidnikPolandCompleted
National Institute Of Tuberculosis And Lung Diseases
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WarsawPolandCompleted
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandCompleted
Karolinska University Hospital
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SolnaSwedenCompleted
CTC Clinical Trial Consultants AB
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UppsalaSwedenCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.