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Evaluation of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
EU CTIS ID: 2025-521278-32-00
What this study is testing
To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants with IPF of any gender ≥40 years of age at time of signing the informed consent
- 10. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and must agree to use and follow medically approved, highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer
- 11. Male participants with female partners of childbearing potential must use condoms during the treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer
- 2. Able to understand the study and provide signed, written informed consent
- 3. Able to read and understand the language of the informed consent and other study related materials
- 4. Meet the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), or Latin American Thoracic Association (ALAT) 2019 criteria for the diagnosis of IPF; diagnosed with IPF within 7 years of Screening
You likely can't join if
- 1. Acute exacerbation of IPF within 6 months of Screening or during the Screening Period
- 10. Currently smoking or vaping
- 11. Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening
- 12. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- 13. Currently pregnant, breast feeding, or planning to conceive for the length of the study
- 14. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening
See the full eligibility criteria
Who can join
- 1. Participants with IPF of any gender ≥40 years of age at time of signing the informed consent
- 10. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and must agree to use and follow medically approved, highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer
- 11. Male participants with female partners of childbearing potential must use condoms during the treatment and until 5 half-lives or 125 days after the last dose of study drug, whichever is longer
- 2. Able to understand the study and provide signed, written informed consent
- 3. Able to read and understand the language of the informed consent and other study related materials
- 4. Meet the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), or Latin American Thoracic Association (ALAT) 2019 criteria for the diagnosis of IPF; diagnosed with IPF within 7 years of Screening
- 5. If a participant is on treatment with pirfenidone, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥90 days prior to Screening, and there should be a plan to maintain the same dose throughout the study Treatment Period. Use of any of these 3 agents in combination with each other is not permitted.
- 6. If a participant was on treatment with nintedanib, pirfenidone, or nerandomilast and the agent has been discontinued, this must have occurred ≥30 days prior to Screening. At Screening, there must also be no plan to start any of these medications for the duration of the study. Participants newly diagnosed with IPF who, in the judgment of the treating physician, are considered in need of treatment with nintedanib, pirfenidone, or nerandomilast should not defer standard of care treatment and should be excluded from the study.
- 7. FVC of ≥45 percent predicted (pp) at Screening
- 8. DLCO of ≥25 pp at Screening
- 9. Willing and able to complete all protocol required study visits and procedures
What rules you out
- 1. Acute exacerbation of IPF within 6 months of Screening or during the Screening Period
- 10. Currently smoking or vaping
- 11. Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening
- 12. Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- 13. Currently pregnant, breast feeding, or planning to conceive for the length of the study
- 14. History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening
- 15. Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant’s ability to complete the study, on-study evaluations, or participant safety
- 16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upper limit of normal (ULN) at Screening
- 17. Presence of interstitial lung disease due to any cause other than IPF, clinically significant cardiovascular disease, or any other concurrent active medical condition determined by the Investigator to interfere with the participant’s ability to complete the study
- 18. Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody
- 19. Any prior use of MTX-463 or other therapy targeting WISP1
- 2. Forced expiratory volume in 1 second (FEV1)/FVC ratio of < 0.7 at Screening
- 20. Any other concurrent experimental agent or an active part of any other clinical study, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer
- 3. Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted
- 4. Expected to receive a lung transplant within the study duration
- 5. Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening
- 6. Planned surgery within the study duration
- 7. Clinically significant pulmonary hypertension
- 8. Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening.
- 9. Use of systemic corticosteroids (prednisone or equivalent) at a dose >10 mg once daily within 30 days of Screening
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United Kingdom
- Australia
- Brazil
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; United Kingdom; Australia; Brazil; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.