Study on the Effects of Bexotegrast for Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical trial is focused on studying a lung disease called idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred over time, making it difficult to breathe. The study will test a new treatment called Bexotegrast, also known by its code name PLN-74809. Bexotegrast is taken as a film-coated tablet and is being compared to a placebo to see how effective and safe it is for people with IPF.

The purpose of the study is to understand how Bexotegrast affects lung function in people with IPF over a period of 52 weeks. Participants will be randomly assigned to receive either Bexotegrast or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The main focus will be on changes in lung capacity, specifically measuring something called forced vital capacity (FVC), which is a way to assess how well the lungs are working.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The study will also look at other aspects of the disease, such as the time it takes for the disease to progress, changes in symptoms like cough and breathlessness, and overall quality of life. The safety of Bexotegrast will be closely monitored by tracking any side effects or serious health events that occur during the study period.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the medication bexotegrast or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.

2 medication administration

Participants will take the assigned medication in the form of a film-coated tablet orally. The dosage and frequency will be determined based on the study’s dose-ranging protocol.

3 treatment duration

The treatment will continue for a period of 52 weeks. During this time, participants will be monitored for changes in their lung function and overall health.

4 monitoring and assessments

Throughout the study, participants will undergo regular assessments to measure the force vital capacity (FVC), which is a test to evaluate lung function. Other assessments will include monitoring for any adverse effects and changes in symptoms such as cough and breathlessness.

5 end of study evaluation

At the end of the 52-week period, participants will have a final evaluation to assess the overall impact of the treatment on their condition. This will include a review of lung function tests and any changes in symptoms or quality of life.

Who Can Join the Study?

  • Must be 40 years of age or older before the screening process.
  • Must have been diagnosed with idiopathic pulmonary fibrosis (IPF) within the last 7 years. This diagnosis should follow specific guidelines and be confirmed by a central review. An HRCT scan (a special type of lung scan) done within the last 2 years can be used to check eligibility.
  • Must have a force vital capacity (FVC) percentage predicted of 45% or higher. This is a measure of lung function and needs to be confirmed by a central review.
  • Must have a diffusing capacity for carbon monoxide percentage predicted (adjusted for hemoglobin) of 30% or more but less than 90%. This is another measure of lung function and also needs to be confirmed by a central review.
  • If currently receiving treatment for IPF, the treatment should be at a stable dose for at least 12 weeks before the screening process.

Who Cannot Join the Study?

  • Having any other lung disease besides idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred for an unknown reason.
  • Having a history of lung cancer.
  • Having a recent lung infection.
  • Using certain medications that might interfere with the study.
  • Having a history of significant heart disease.
  • Having uncontrolled high blood pressure.
  • Having a history of liver disease.
  • Having a history of kidney disease.
  • Being pregnant or breastfeeding.
  • Having participated in another clinical trial recently.
  • Having a history of drug or alcohol abuse.
  • Having any condition that the study doctors think would make it unsafe to participate.

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
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
University Medicine Greifswald Greifswald Germany
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Unidade Local De Saude De Sao Jose E.P.E. Lisbon Portugal
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Zentralklinik Bad Berka GmbH Bad Berka Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Algemeen Ziekenhuis Delta Roeselare Belgium
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
Hospital Quironsalud Marbella Marbella Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Ip Clinic Sp. z o.o. Lodz Poland
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Krankenhaus Bethanien gGmbH Solingen Germany
GWT-Tud GmbH Coswig Germany
Multimedica S.p.A. Milan Italy
Giromed Institute S.L.P. Barcelona Spain
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Ioannina Ioannina Greece
Odense University Hospital Odense Denmark
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Saarland University Hospital Homburg Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Kliniken der Stadt Koeln gGmbH Cologne Germany
General University Hospital Of Patras Patras Greece
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nice Nice France
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Centre Hospitalier Universitaire De Rennes Rennes France
University Hospital Olomouc Olomouc Czechia
Gentofte Hospital Hellerup Denmark
Hospital Alvaro Cunqueiro Vigo Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Fakultni Thomayerova nemocnice Prague Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Zgsgykp Mswjvyh Crdudg Slv z obae Lublin Poland
Aulnoyd Oqkngipudnk Pvtq Gnxylhfk Xscoq Bergamo Italy
Cibtzy Hzocslojpxx Uqoatjwujlvtr Rxzlg Reims France
Hxxoiyub Uresnjlcwzdwk Dl Ld Pzsfzbhg Madrid Spain
Mblgsldqn Iecmkzduwh Cosbfpwk Spcngbij Sqd z ofos Warsaw Poland
Lxiaw Gkiiwhu Hdniipww Ow Agwzpe Athens Greece
Aqyoxvdie Uhm Amsterdam The Netherlands
Agfewfcxcr Pzceupjw Hnlmypmq Dc Mzaigvjgq Marseille France
Aqrhgvh Odkyicyhkfw Ukrvrfssxdyxz Snrkwk Siena Italy
Aveywx Ubbzzrvkxb Halejglu Aarhus Denmark
Caspcv Hnlgqojtkla Rcbplnuv Uhsevbjeotydf Dy Ttgrr Tours France
Atgfxkq Opefddgpbmw Uorloeswvkebe Ccackhyczudi Dpmum Seucvi E Dfygr Smnjcge Do Tvpxnr Turin Italy
Arofgbw Ogehbtkduvi Noiucildh Sj Aawkkzz E Baiykn E C Axnfjx Ayaqwspozvw Alexandria Italy
Agwaovy Oivwylicvxx Umnhmkegdcbvk Osectkhu Rmtjlww Foggia Italy
Kvzetlin dtm Ubdtqblrbbgf Mfvmudbx Amg Munich Germany
Uffqehzoqvpzrd Cdqwwfx Krxddrhsw Gdansk Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.04.2024
Czechia Czechia
Not recruiting
01.04.2024
Denmark Denmark
Not recruiting
01.04.2024
France France
Not recruiting
01.04.2024
Germany Germany
Not recruiting
01.04.2024
Greece Greece
Not recruiting
01.04.2024
Italy Italy
Not recruiting
01.04.2024
Poland Poland
Not recruiting
01.04.2024
Portugal Portugal
Not recruiting
01.04.2024
Spain Spain
Not recruiting
01.04.2024
The Netherlands The Netherlands
Not recruiting
01.04.2024

Trial locations

Investigated drugs:

Bexotegrast is a medication being studied for its potential to treat idiopathic pulmonary fibrosis (IPF). This condition causes scarring of the lungs, making it difficult to breathe. The trial aims to see how well bexotegrast can improve lung function over a period of 52 weeks.

Investigated diseases:

Idiopathic Pulmonary Fibrosis (IPF) – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for individuals to breathe. The exact cause of IPF is unknown, which is why it is termed “idiopathic.” Over time, the thickening and stiffening of lung tissue reduce the lungs’ ability to transfer oxygen into the bloodstream. Symptoms often include a persistent dry cough and shortness of breath, especially during physical activity. As the disease progresses, individuals may experience fatigue, weight loss, and clubbing of the fingers.

Trial ID:
2023-506185-31-00
Protocol code:
PLN-74809-IPF-206
Trial Phase:
Therapeutic use (Phase IV)

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