Study of MTX-463 compared to placebo to assess its safety and effectiveness in adults with idiopathic pulmonary fibrosis

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What is this study about?

This study focuses on people with Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring of the lung tissue, making it difficult to breathe. The research evaluates a new medication called MTX-463, which is given through intravenous injection. The purpose of the study is to determine how well MTX-463 works in improving lung function in people with IPF.

During the study, participants will receive either MTX-463 or placebo through intravenous administration over a period of 20 weeks. Some participants may continue their current IPF medications, such as pirfenidone or nintedanib, if they have been on a stable dose. The study will measure how well participants’ lungs work by checking their forced vital capacity (FVC), which is the amount of air a person can forcefully exhale after taking a deep breath.

The study will track any changes in participants’ lung function over 24 weeks. Throughout the study, doctors will monitor participants’ health through regular check-ups and tests. The research team will also keep track of any side effects that may occur during the treatment period. Some participants will receive sodium chloride solution or glucose solution as part of the study procedures.

1 Initial evaluation

Your eligibility for the study will be assessed based on specific criteria, including being at least 40 years of age and having a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within the last 7 years

Medical tests will be performed to verify your lung function, including forced vital capacity (FVC) which must be at least 45% of predicted value

A breathing test called DLCO will be conducted, which must show at least 25% of predicted value

2 Medication requirements

If you are currently taking medications called pirfenidone or nintedanib, your dose must have been stable for at least 90 days before starting the study

If you previously stopped taking these medications, this must have occurred at least 30 days before screening

You cannot take both medications together during the study

3 Treatment period

You will receive either MTX-463 or a placebo through an intravenous infusion

The study will measure changes in your lung function over a 24-week period

Regular assessments will monitor your health status and any potential side effects

4 Safety monitoring

Throughout the study, you will undergo regular physical examinations

Your vital signs and laboratory test results will be monitored

Any side effects or adverse reactions will be recorded and evaluated

5 Study completion

The main measurement will be the change in your lung function (FVC) from the start to week 24

Additional measurements will include changes in the percentage of predicted FVC

The study is expected to continue until May 19, 2028

Who Can Join the Study?

Must be 40 years of age or older at the time of signing consent
Must be diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 7 years
Must be able to understand, read, and sign the study consent forms
Must have a Forced Vital Capacity (FVC) of 45% or higher of predicted value (FVC measures how much air you can exhale after taking a deep breath)
Must have a DLCO of 25% or higher of predicted value (DLCO measures how well oxygen moves from your lungs into your blood)
If taking pirfenidone or nintedanib (medications for IPF), the dose must be stable for at least 90 days before screening and must remain stable throughout the study
If previously taking pirfenidone or nintedanib, must have stopped these medications at least 30 days before screening
Must be willing and able to complete all required study visits and procedures
Women who can become pregnant must have a negative pregnancy test at screening
All participants who can reproduce must use effective birth control during treatment and for 125 days after the last dose
Cannot take both pirfenidone and nintedanib together during the study

Who Cannot Join the Study?

History of other respiratory conditions besides IPF (such as asthma, chronic bronchitis, or emphysema)
Current smokers or those who quit smoking less than 6 months ago
Pregnant or breastfeeding women
People with severe liver problems (abnormal liver function tests)
People with severe kidney problems (impaired kidney function)
History of heart disease or significant heart problems
Active infections, including respiratory infections
Participation in other clinical trials within the last 30 days
Known allergic reactions to similar medications
People taking certain medications that might interact with the study drug
Significant abnormal blood test results
History of alcohol or drug abuse within the past year
People unable to perform the required breathing tests
Mental conditions that could interfere with following study procedures
Life expectancy less than 12 months due to other medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hôpital Européen Georges-Pompidou	Paris	France

Other Sites

Site Name	City	Country
Our Lady Of Lourdes Hospital	Drogheda	Ireland
Giromed Institute S.L.P.	Barcelona	Spain
Tallaght University Hospital	Dublin	Ireland
Hospital Clinic De Barcelona	Barcelona	Spain
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
KBC Split	Split	Croatia
Centre Hospitalier Universitaire De Nice	Nice	France
Connolly Hospital	Dublin	Ireland
Ccrmvipda Uxmfrkuggifyil Srzypbyap	Woluwe-Saint-Lambert	Belgium
Heqpdiyc Uuwpwhspkzmmx Myuiuoz Dg Votszhvzna	Santander	Spain
Fvxcpwwy Ikpllpzr Dcculmyjudrbvleyrobc Bnpdsnfdg Dh Bwlwbgtlx Iacfvds	L'hospitalet De Llobregat	Spain
Luzfzntolcc Ummwebcpnt Htcbdpdx	Letterkenny	Ireland
Uwevtlmxgz On Afhgwmf	Edegem	Belgium
Edmndmq Ucydbwsfmswu Mgtwhkv Czdfhmp Rzgzeddui (ndktppc Myd	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.09.2025
Croatia	Recruiting	15.09.2025
France	Recruiting	15.09.2025
Ireland	Recruiting	15.09.2025
Spain	Recruiting	15.09.2025
The Netherlands	Recruiting	15.09.2025

Trial locations

Investigated drugs:

Sodium Chloride

MTX-463 is an investigational medication being studied for the treatment of idiopathic pulmonary fibrosis (IPF), a condition that causes scarring in the lungs. The medication is being tested to see if it can help improve lung function, specifically the amount of air a person can exhale after taking a deep breath (forced vital capacity). Since this is a Phase 2 study, researchers are working to understand both how well the medication works and its safety profile in patients with IPF.

Investigated diseases:

Idiopathic pulmonary fibrosis

Idiopathic Pulmonary Fibrosis (IPF) – A rare, progressive lung disease that causes scarring (fibrosis) of lung tissue over time. The scarring causes the lung tissue to become thick and stiff, making it increasingly difficult to breathe. The term “idiopathic” means the cause of the scarring is unknown. The disease typically develops slowly, with lung tissue becoming gradually more damaged. As the condition progresses, the lungs have increasing difficulty transferring oxygen into the bloodstream during breathing. The disease mainly affects people over the age of 50 and is characterized by a dry, persistent cough and shortness of breath that gradually gets worse.

Trial ID:

2025-521278-32-00

Protocol code:

MTX-463-I201

NCT ID:

NCT06967805

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of MTX-463 compared to placebo to assess its safety and effectiveness in adults with idiopathic pulmonary fibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?