Study of BI 765423 given by intravenous infusion for patients with idiopathic pulmonary fibrosis with or without standard treatment

What is this study about?

This study focuses on patients with Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring of the lung tissue. The research evaluates a new medication called BI 765423, which is given through intravenous administration. The study aims to determine if this new treatment can improve lung function in people with IPF, either when used alone or in combination with standard treatments.

The study uses two different treatments: some participants will receive BI 765423, while others will receive a placebo. Neither the patients nor their doctors will know which treatment is being given. The medication or placebo will be administered through an injection into a vein. The study will track changes in participants’ lung function over a period of 12 weeks.

During the study, various measurements will be taken to monitor lung function, including breathing tests and walking tests. Participants will be regularly monitored to ensure their safety throughout the treatment period. The study will last approximately 24 months, during which participants will need to attend multiple clinic visits for assessments and treatment administration.

1 Initial assessment

A medical evaluation will confirm your diagnosis of idiopathic pulmonary fibrosis (IPF).

Your lung function will be measured through tests including forced vital capacity (FVC) which must be at least 45% of normal values.

A chest scan (HRCT) from the past 12 months will be reviewed to confirm at least 20% lung fibrosis.

2 Treatment assignment

You will be randomly assigned to receive either BI 765423 or a placebo through intravenous infusion.

If you are currently on standard IPF treatment, you may continue it during the study.

3 Treatment period

The treatment will continue for 12 weeks.

During this time, you will receive the study medication or placebo through intravenous infusions.

4 Monitoring visits

Regular assessments will measure:

– Your lung function (FVC)

– Blood oxygen levels

– Walking distance in a 6-minute walk test

– Blood tests for specific markers

– Your breathing capacity (DLCO test)

5 Final assessment

After 12 weeks, final measurements will be taken to evaluate changes in your lung function and other health indicators.

The main focus will be on changes in your FVC measurement compared to the start of the study.

Who Can Join the Study?

Must be 40 years of age or older when signing the consent form
Must have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF) before the first visit, verified by medical guidelines
Must have had a high-resolution CT scan (detailed chest imaging) within the past 12 months showing specific patterns of lung changes
Must have lung scarring affecting at least 20% of the lungs, confirmed by chest imaging
Must have a Forced Vital Capacity (FVC) of at least 45% of normal (FVC measures the amount of air you can exhale after taking a deep breath)
Must have a DLCO of at least 20% of normal (DLCO measures how well oxygen moves from your lungs into your blood)
For women: Must be post-menopausal (no menstrual periods for 12 months) or permanently surgically sterilized
For men: Must use appropriate contraception if having sexual partners who can become pregnant
Must be willing and able to provide written informed consent

Who Cannot Join the Study?

Age below 18 years or above 85 years
Pregnancy or breastfeeding
History of lung transplantation
Active infections of the lungs
Severe liver disease (where liver is not functioning properly)
Severe kidney disease (where kidneys are not functioning properly)
Current participation in other clinical trials
Known allergies to the study medication or similar drugs
Cancer treatment in the past 5 years
Unstable heart conditions (such as recent heart attack or severe heart failure)
Unable to perform lung function tests correctly
Major surgery planned during the study period
Alcohol or drug abuse within the past year
Mental conditions that could interfere with following study procedures
Use of medications that could interact with the study drug

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
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
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH	Essen	Germany
GWT-Tud GmbH	Coswig	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Cjuicgesp Unzpaanwrduaua Sxnokcrpc	Woluwe-Saint-Lambert	Belgium
Hmogasgw Ujerneyyvfpgk Db Lj Pphawxsx	Madrid	Spain
Acxwiyc Otizqivnarz Uxlzyptmpxsmy Ccvbezbqzdxb Dache Smblgv E Dlygm Skzjnwv Dl Ttoldz	Turin	Italy
Amezdxo Oriyqqriico Prsh Guqirhdx Xbapo	Bergamo	Italy
Hivlrcdq Vbtc dyccfkhm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	03.11.2025
Germany	Recruiting	03.11.2025
Italy	Recruiting	03.11.2025
Spain	Recruiting	03.11.2025

Trial locations

BI 765423 is an investigational medication being studied for the treatment of idiopathic pulmonary fibrosis (a lung condition that causes scarring of the lungs). It is given through intravenous administration (directly into the vein). This medication is being tested to see if it can help improve lung function in patients with this condition.

Standard of care refers to the current best available treatment that patients typically receive for idiopathic pulmonary fibrosis. This may include currently approved medications that help manage the condition.

Investigated diseases:

Idiopathic pulmonary fibrosis

Idiopathic Pulmonary Fibrosis (IPF) – A rare lung disease that causes progressive scarring (fibrosis) of lung tissue. The scarring process gradually makes lung tissue thick and stiff, reducing its ability to expand and transfer oxygen into the bloodstream. Over time, this condition causes the lungs to lose their ability to take in and transfer oxygen to the body’s vital organs. The term ‘idiopathic’ means the cause of the scarring is unknown. The disease typically develops slowly, with symptoms including shortness of breath and a dry, persistent cough. The condition primarily affects people over 50 years of age.

Trial ID:

2025-520658-12-00

Protocol code:

1493-0002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of BI 765423 given by intravenous infusion for patients with idiopathic pulmonary fibrosis with or without standard treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?