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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

MTX-463 - A novel investigational drug currently in Phase 2 clinical trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a serious lung condition that causes scarring of lung tissue. The medication is being studied to evaluate its effects on improving forced vital capacity (FVC), which is a measure of lung function in IPF patients. While the specific mechanism of action and administration route are not yet publicly disclosed as the drug is still in clinical trials, this experimental treatment is being tested against placebo to determine its safety and effectiveness in managing IPF symptoms and potentially slowing disease progression.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521278-32-00Protocol codeMTX-463-I201Estimated enrolment164 patientsSponsorMediar Therapeutics Inc.

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