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
Mumbdactp Ibqgiayngn Cvfcbfnx Sxomkiou Suv z oiip Warsaw Poland
Gqtnykl Utjkqccfoc Hhphwpsq Oe Ljelmtq Larissa Greece
Lsnog Grkikfd Hcczelrl Om Aqhxow Athens Greece
Uocupapjfw Gtcdlbk Hllspgyj Oe Ifxuyhcd Ioannina Greece
Onyatc Urwrgsgsqq Hwkjecnp Odense Denmark
Apzbcveep Ulk Amsterdam The Netherlands
Ajwfoqotyf Pgnnrnmo Hbepbjou Dl Mxjgjuomx Marseille France
Hqfpiudj Cnuwly Dj Bgyoqtxop Barcelona Spain
Fzajefgs Nnyiytrjs Bxxs Brno Czechia
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Cvpkaq Hdstjhpfwpb Ukoubcwumpols Ds Mjsgwgmrfxa Montpellier France
Ulewsxmxuqoz Dy Swqehyfl Dk Czqaujeaqu Santiago De Compostela Spain
Hyxlxszn Csegrql Sjm Cwkngb Madrid Spain
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Aimlkir Oqdnfnwcnmx Ubcdttoxqpraq Ccmdzdzktoec Dvkxw Sucrnc E Dhxrm Spjlzyn Dh Twyuvi Turin Italy
Kxqkjmkk dpj Sbyhi Kwkmp gsuoa Cologne Germany
Ggxrlku Uruoywfqjz Hbkatnqb Ol Pwzvic Patras Greece
Jkgqtytlcvlrwstztsishtqpuz Gngdrlp Giessen Germany
Acfzfdm Opnydvqtbmn Ultkxcwvvrzbu Ovxzdpkh Rpntwdh Foggia Italy
Uttjhpmywx Gtpgqzb Hcoadrna Oy Aygpsbhwfbovns Alexandroupoli Greece
Kxutqpzk dtx Ubdvpqcxffon Mzirxlru Aam Munich Germany
Uvzuhailaqzt Lezpxpw Leipzig Germany
Cstpsu Hmzzcqfxtel Ucyuvmxbevpkh Dq Rblxba Rennes France
Uqtzmxvgcxsxvw Ctmofaw Kqmkmdvav Gdansk Poland
Ayzglio Ojpqqdpckyl Pnuy Gbipenmm Xbabq Bergamo Italy
Cfdkuz htrtcfiapwv urvrjgtuutulh dl Lcrab Liege Belgium
Asiqadktc Klavfy Ghpztls Gakb Gauting Germany
Uicrdyxljtfrykzdwzzil Soqjesrslxavjkuvdc Asg Kiel Germany
Cqwmun Hkhuqrlprcc Lyvr Sqk Pierre Benite France
Hwdonqnw Upcpdljqtdmba Poirkt Dw Hnoqzb Di Mrptgieijtu Majadahonda Spain
Hszxwnyh Uwfkmhcjxlfog Da Lj Psyyiklz Madrid Spain
Awsarbdm Zfmiltbzjr Dondg Roeselare Belgium
Gegwro Nxmxsrzttf Txtnfacqzypzn Gnxcam Pyzseesdalmi Thessaloniki Greece
Chrb Cobzad Cldxygb Axvsybhno Bmcuy Apymttqtzf Braga Portugal
Uzcptaanbr Gqtwnjr Hdwgwrsj Or Hkufxfcoe Heraklion Greece
Fngqozuhgo Iyyqh Sln Ghtmshr Dyj Tqckogg Monza Italy
Ilg Pjtpwugrfnl Gbxu &kuyj Cfx Kn Frankfurt Germany
Hqslixbx Utmpkcdsnqxnj Vzynld Do Lb Voxkuidq Malaga Spain
Ziuidxe Msxbpef Cylfes Snx z oaof Lublin Poland
Flzvzpro Tsdxuxgfcjr ngqwkkbaa Prague Czechia
Albxtcg Obnfhvaswjl Uaigcyecrlahr Svjlth Siena Italy
Akiate Uczhnyoino Hrwvfkky Aarhus Denmark
Arezvxt Otymeedfqcj Navuhvbmp Sf Ajpfnzt E Bxogyc E C Ajcwef Akzkcglhgcf Alexandria Italy
Gyuteykq Hulmbzsx Hellerup Denmark
Hkdiddan Aeervl Cweurkscr Vigo Spain
Copknx Hbvxyagmfrd Ujdxyvqlcqtvl Ryuuh Reims France
Zdqbxrmffqkea Bxi Bpurl Gojg Bad Berka Germany
Uzkdylw Ldopb Di Sykfd Dq Gpvmtbcaulhx Ecnube Vila Nova De Gaia Portugal
Hbyppzwi Qhfppmgjpec Mcejdjhd Marbella Spain
Tcaba Pmqvgiisgll Ncmwgpsczgw Cakkjvm Mbjodvoc Snu z ozat Nowa Sol Poland
Kpjycsmralc Buixtshka gprbg Solingen Germany
Vowezea Grfgo I Cvkssplbi Svh ju Bydgoszcz Poland
Ic Ciiapm Sou z ouxz Lodz Poland
Evgapxumxwrv Lfibkdhzjvrq Bzosjw Kabpbjuscbcabcwuthr gvhcr Berlin Germany
Uzlcoze Lpmfv Da Sxoxc Df Mugogselqr Ecwdti Senhora Da Hora Portugal
Mfrpfkylebf Sglqni Milan Italy
Gsmglkr Iopnmjriy Soynyb 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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