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
- Diseases
- Idiopathic pulmonary fibrosis
- 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
Sites (75)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Universitaetsklinikum Krems Coordinator of this site? Confirm its status | Krems An Der Donau | Austria | Completed |
| Johannes Kepler University Linz Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Stadt Wien Wiener Gesundheitsverbund Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Completed |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Fakultni nemocnice Bulovka Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| Pneumologische Praxis Dr. Löh Coordinator of this site? Confirm its status | Bad Homburg | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Caritas-Krankenhaus St. Maria gGmbH Coordinator of this site? Confirm its status | Donaustauf | Germany | Completed |
| Klinikum Fulda gAG Coordinator of this site? Confirm its status | Fulda | Germany | Completed |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Completed |
| Klinikum Region Hannover GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Coordinator of this site? Confirm its status | Hemer | Germany | Completed |
| Lungenfachklinik Immenhausen Coordinator of this site? Confirm its status | Immenhausen | Germany | Completed |
| Klinikum Konstanz GmbH Coordinator of this site? Confirm its status | Konstanz | Germany | Completed |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital de Galdakao-Usansolo Coordinator of this site? Confirm its status | Galdakao | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Completed |
| Pohjois-Pohjanmaan hyvinvointialue Coordinator of this site? Confirm its status | Oulu | Finland | Completed |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Completed |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Bobigny | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Completed |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Forli' | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Multimedica S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Completed |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lorenskog | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. Coordinator of this site? Confirm its status | Świdnik | Poland | Completed |
| National Institute Of Tuberculosis And Lung Diseases Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| CTC Clinical Trial Consultants AB Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.