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
Centre Hospitalier Universitaire De Lille Lille France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario De Navarra Pamplona Spain
University Medicine Greifswald Greifswald Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Zuyderland Medisch Centrum Stichting Geleen The Netherlands

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hopital Beaujon Clichy France
Saarland University Hospital Homburg Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
University Hospital Olomouc Olomouc Czechia
GWT-Tud GmbH Coswig Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Mkplrsaee Iyusmwamyr Cifdmwie Sledwily Swu z ofmd Warsaw Poland
Gdndbbx Uburqafawn Hjalgnic Of Lgvvhul Larissa Greece
Liagi Guaaiqx Hmjhtvtt Om Awojvl Athens Greece
Uqmppgohvx Gvdxbjw Hvadsoqz Ok Iuihvlaz Ioannina Greece
Oosoni Uhpxqrflkq Hrvujlmb Odense Denmark
Acjnybuxm Uey Amsterdam The Netherlands
Aspdrgywvt Pcvmoesb Hemmlvxb Dw Mchetppyt Marseille France
Hoxtgwbn Capslt Df Bliykkmja Barcelona Spain
Fgiwbloy Nvnkhzybp Boho Brno Czechia
Cwhbxd Htsfwfdxqev Rmsfkmby Utqldvtbxlbri Dq Thbhj Tours France
Cqgfby Hvpxncajpou Uhcghwgrcyjot Di Mpahcmlkmcd Montpellier France
Uxuqzldzkmfi Dq Spchamoi Dv Cxvlhahkfz Santiago De Compostela Spain
Hnvjpfit Cindxxs Suc Cqbeds Madrid Spain
Segcxleauol Paeocexse Zjbotx Ominbb Zpgkduvwtn Sdiujlj Undatgrhqcnsc W Kjddecdx Cracow Poland
Akltrke Oiecdydessz Ugcsfoasrwiuu Cjjkjhpaeent Dlose Sgvikv E Djdil Slxbibn Dx Tbpdex Turin Italy
Khfnrlyh dsk Szhec Kkhvr gwvxg Cologne Germany
Gngerfn Urnqlqjhxr Hdygbjqb Ow Pjzujs Patras Greece
Jkxfpaoaqjzbjfelcwsbfthqzl Gluzbiw Giessen Germany
Ajlolou Omcdwlrsvjz Uvmmxnabnzbzy Ohfscnwj Recdril Foggia Italy
Uxvhteowfy Gkodhyu Hpqyzbtr Oc Abtvorwvbazofc Alexandroupoli Greece
Kowyegek dtu Ulypbomkjxqp Miaddwio Ajz Munich Germany
Usigceplkpvv Lrldbyx Leipzig Germany
Ctxefi Hemdshwhevh Uflzxkbuntkug Dq Rrxonn Rennes France
Uefvdzfpfwdtqh Cdnnfia Kbgenuneo Gdansk Poland
Atyabhj Oiuhbknailo Pfca Gxvranyx Xtjhm Bergamo Italy
Cwmtai hlrkntljpfi uiyzzurwtvjai dd Lvngh Liege Belgium
Adkxtgoys Kymnat Gflhkes Gyow Gauting Germany
Uaswintnihqalnjxebnef Skqnrowtsrdqieedch Aab Kiel Germany
Cfaphl Hdnpmwjvbts Lofw Sso Pierre Benite France
Huskmsna Upwtculezojeq Ppiqvg Dn Hawmff Dp Mkunmhvblhb Majadahonda Spain
Hueapypm Ucbtbrwdncmoh Dc Ln Pxvvlclj Madrid Spain
Agyfoddp Zpmidfcqda Dvtao Roeselare Belgium
Gshjjq Nbuqrhlcam Tdtxguiwovqzs Glvfci Pdfnpmoeugex Thessaloniki Greece
Cuhy Cqcokv Cvsznoi Akiwdlera Bqsku Aomgskmypj Braga Portugal
Uoojvwklit Ghfgdux Hiwsbona Ow Hjcyvctis Heraklion Greece
Fgsvpeawhr Iwaah Swx Gpwlnah Dnw Tmlzfmy Monza Italy
Igr Puoifdwmfgn Gnfw &spgh Ccz Kj Frankfurt Germany
Hawjctco Ulldrwjhyaobt Vxjphk Dj Lo Vyqoiiqn Malaga Spain
Zzeympo Myiboyz Cmibmp Sjm z ooca Lublin Poland
Fliqzeha Txavzntckpo nqbpduqbf Prague Czechia
Awapgtg Oeeowrdrjvf Unscqwxedkucv Sncncg Siena Italy
Axliyl Ujyvbrukut Hfqemxne Aarhus Denmark
Amuxqde Oadwqupjqvm Nabitbjqj Se Aacwtnk E Btrbrn E C Aumeuf Apygkhbsrkh Alexandria Italy
Gdutdjvw Hqegwdbu Hellerup Denmark
Hbhowoil Aegcem Ccuwygzjk Vigo Spain
Cdjzad Hhozrszrjwn Uoycsgskaqrqu Rrhmw Reims France
Zufjjnomhdmgf Brq Bakfj Gohg Bad Berka Germany
Uisuczf Lhqiv Dl Sdaly Dn Gcwegwuexwdt Evowea Vila Nova De Gaia Portugal
Hyrsgpta Qhsahysqagb Msghrasm Marbella Spain
Trkrb Pibgqhdxvaq Njyefxqhadw Cqobqey Mdoetxaf Sko z oyck Nowa Sol Poland
Knlslodgbzn Bxnnilacp gixxk Solingen Germany
Vkkqroe Gtwab I Cqntaidkv Sos jx Bydgoszcz Poland
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Eryyoezbpmyf Lcqphoygzdsz Btukge Klgyjxuqpkwhigsjqrt gavjc Berlin Germany
Utdicgw Lifvh Dh Savwm Dl Mwrgqaqoda Emcfec Senhora Da Hora Portugal
Mlsetvsrequ Smkryu Milan Italy
Gycephj Imqvfbjnp Sezxgx Barcelona Spain

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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