Study on BI 1819479 to Improve Lung Function in Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring of the lungs, making it difficult to breathe. The study will test a new treatment called BI 1819479, which is taken as a film-coated tablet. The purpose of the study is to see if BI 1819479 can improve lung function in people with IPF.

Participants in the study will be randomly assigned to receive either BI 1819479 or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for at least 24 weeks, and participants will take the medication orally. The researchers aim to find the most effective dose of BI 1819479 by comparing different doses to the placebo.

Throughout the study, the main focus will be on measuring changes in lung function, specifically the rate at which lung capacity declines over time. This will help determine if BI 1819479 can slow down the progression of IPF. The study will also look at the safety and tolerability of the medication to ensure it is safe for patients to use.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the medication BI 1819479 or a placebo. The placebo is a tablet that looks identical to the medication but does not contain the active substance.

The study is designed to be double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

2 medication administration

The patient will take the assigned tablet orally. The specific dosage and frequency will be determined by the study protocol, which aims to evaluate different doses of BI 1819479.

The treatment period will last for at least 24 weeks, with the possibility of extending up to a maximum of 52 weeks.

3 monitoring and assessments

Throughout the study, the patient’s lung function will be regularly monitored. This includes measuring the Forced Vital Capacity (FVC), which is the amount of air the patient can forcibly exhale from the lungs after taking the deepest breath possible.

The primary goal is to assess the annual rate of decline in FVC over the treatment period.

4 end of treatment evaluation

At the end of the treatment period, the patient will undergo a final evaluation to measure any changes in lung function, specifically the absolute change in FVC from the baseline at Week 24.

The results will help determine the effectiveness and safety of BI 1819479 in treating idiopathic pulmonary fibrosis.

Who Can Join the Study?

  • Patients must be 40 years or older at the time they sign the consent form.
  • Must provide a signed and dated written consent form, following international and local guidelines, before joining the trial.
  • Must have a diagnosis of idiopathic pulmonary fibrosis (IPF) based on specific medical guidelines from 2022.
  • Must be on a stable treatment with either nintedanib or pirfenidone for at least 12 weeks, or not on these treatments for at least 12 weeks.
  • Must have a Forced Vital Capacity (FVC) of at least 45% of what is considered normal. FVC is a test that measures how much air you can exhale after taking a deep breath.
  • Must have a DLCO of at least 25% of what is considered normal, adjusted for hemoglobin levels. DLCO is a test that measures how well your lungs transfer oxygen into your blood.
  • Women of childbearing potential must use highly effective birth control methods and an additional barrier method, like a condom, for their male partners until the end of the follow-up period.
  • Male participants with partners who can become pregnant must use condoms to prevent exposure through seminal fluid. Their female partners must also use highly effective birth control methods during the treatment and until the end of the follow-up period.

Who Cannot Join the Study?

  • Patients with any other lung disease besides idiopathic pulmonary fibrosis cannot participate. Idiopathic pulmonary fibrosis is a condition where the lungs become scarred and breathing becomes difficult.
  • Patients who have had a recent lung infection or illness that affects their breathing are not eligible.
  • Patients who have undergone lung surgery in the past 6 months cannot join the study.
  • Patients who are currently taking medications that might interfere with the study treatment are excluded.
  • Patients with a history of severe heart problems are not allowed to participate.
  • Patients who have been diagnosed with cancer in the past 5 years are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with a known allergy to the study medication or its ingredients cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Kuopio University Hospital Kuopio Finland
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Koranyi National Institute For Pulmonology Budapest Hungary
Lungenfachklinik Immenhausen Germany
University Medicine Greifswald Greifswald Germany
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Universitaet Leipzig Leipzig Germany
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre hospitalier universitaire de Liege Liege Belgium
Klinikum Region Hannover GmbH Hanover Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Klinikum Wels-Grieskirchen GmbH Wels Austria
Fakultni Nemocnice Bulovka Prague Czechia
Hospital Universitario Infanta Leonor Madrid Spain
University General Hospital Of Heraklion Heraklion Greece
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Hospital De Galdakao Usansolo Galdakao Spain
Universitaetsklinikum Krems Krems An Der Donau Austria
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Multimedica S.p.A. Milan Italy
Azienda Ospedaliera di Padova Padua Italy
University Of Debrecen Debrecen Hungary
University General Hospital Of Ioannina Ioannina Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
CTC Clinical Trial Consultants AB Uppsala Sweden
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nice Nice France
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Rennes Rennes France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Rigshospitalet Copenhagen Denmark
Klinikum Konstanz GmbH Konstanz Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Pirkanmaan hyvinvointialue Tampere Finland
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o. Lublin Poland
Fakultni Thomayerova nemocnice Prague Czechia
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hospital Universitario Virgen De La Victoria Malaga Spain
Colyopfqg Ujkfhbaabonpbz Sefmfmowp Woluwe-Saint-Lambert Belgium
Oeynrlmrdbuoyt Lszz Gfoy Linz Austria
Hqnbqgiu Ucdasietpdpry Dj Lh Pzntzpaz Madrid Spain
Hswojron Udlicqvsoatdv Mvrnygq Dl Vbfukpffay Santander Spain
Nrefnyjc Ifszoeccn Or Tiijomroqfua Akr Lyre Dtabscng Warsaw Poland
Kjjbir Dfgsrxvbiu Donaustauf Germany
Pbroeagtlyapue Pnxgzn Dqr Lgj Bad Homburg Germany
Knougzzc Faywy ghy Fulda Germany
Aoaiotqhca Ptefkisp Hnfmtqce Da Mqqazsswd Marseille France
Ahcyotvl Uuzdhrchpk Hqsnqjcr Lorenskog Norway
Hljfm Bfdfzx Hh Bergen Norway
Hlkoauhd Uykwzwllcy Cenfhio Hrxmzbno Helsinki Finland
Abznnjt Oasisujkbej Uvpdltyusvcje Okvzwvbr Rsobqcd Foggia Italy
Kncghnlf djo Udwduikuztiu Mkpgewff Alp Munich Germany
Clpwgl Heugtyngaor Rvafxikq Dhteyzxznxfmkw Angers France
Jpppcrkb Ktvpfe Uilekgjsbx Linz Austria
Hpooczmf Vphy dbqawbti Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
09.09.2024
Belgium Belgium
Not recruiting
09.09.2024
Czechia Czechia
Not recruiting
09.09.2024
Denmark Denmark
Not recruiting
09.09.2024
Finland Finland
Not recruiting
09.09.2024
France France
Not recruiting
09.09.2024
Germany Germany
Not recruiting
09.09.2024
Greece Greece
Not recruiting
09.09.2024
Hungary Hungary
Not recruiting
09.09.2024
Italy Italy
Not recruiting
09.09.2024
Norway Norway
Not recruiting
09.09.2024
Poland Poland
Not recruiting
09.09.2024
Spain Spain
Not recruiting
09.09.2024
Sweden Sweden
Not recruiting
09.09.2024

Trial locations

Investigated drugs:

BI 1819479 is an investigational medication being studied for its potential to treat idiopathic pulmonary fibrosis (IPF). This medication is being tested to see how effective and safe it is for patients with this lung condition. The study aims to find the best dose that provides the most benefit with the least side effects.

Investigated diseases:

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue. This scarring, known as fibrosis, leads to a progressive decline in lung function. The exact cause of the disease is unknown, which is why it is termed “idiopathic.” As the disease progresses, individuals may experience increasing difficulty in breathing and reduced oxygen levels in the blood. The condition typically worsens over time, leading to more severe respiratory symptoms. The progression rate can vary among individuals, with some experiencing a more rapid decline in lung function than others.

Trial ID:
2023-508395-11-00
Protocol code:
1462-0004
Trial Phase:
Therapeutic exploratory (Phase II)

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