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Evaluating MTX-463 for treating Idiopathic Pulmonary Fibrosis

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2 Interventional Mediar Therapeutics · NCT06967805

This study is testing a new treatment called MTX-463 to see if it can help people with Idiopathic Pulmonary Fibrosis breathe better and stay safe while still using their current medications.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment164 (estimated)
Ages40 Years and up
SexAll
SponsorMediar Therapeutics Industry-sponsored
Drugs / interventionsprednisone
Locations69 sites (Birmingham, Alabama and 68 other locations)
Trial IDNCT06967805 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial evaluates the safety and efficacy of MTX-463 in participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF). Participants will be randomly assigned to receive either MTX-463 or a placebo via intravenous infusion every four weeks for a total of five infusions. The study will assess lung function and safety through various evaluations, including forced vital capacity (FVC) measurements and blood tests for safety and biomarker levels. The trial will also allow participants to continue their stable treatment with approved IPF therapies, pirfenidone or nintedanib.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of IPF within the last seven years.

Not a fit: Patients who have not been diagnosed with IPF or those who are not able to maintain stable doses of existing IPF medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Idiopathic Pulmonary Fibrosis.

How similar studies have performed: Other studies have shown promise in targeting similar pathways in IPF, but the specific approach with MTX-463 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent.
* Able to understand the study and provide signed, written informed consent.
* Able to read and understand the language of the informed consent and other trial-related materials.
* Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.
* If a participant is on treatment with pirfenidone or nintedanib, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study treatment period. Use of both agents together is not permitted.
* If a participant was on treatment with nintedanib or pirfenidone, 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 either of these medications for the duration of the study.
* FVC of ≥ 45 percent predicted (pp) at screening.
* DLCO of ≥ 25pp at screening.
* Willing and able to complete all protocol required study visits and procedures.
* All participants of childbearing potential must have a negative serum pregnancy test at Screening.
* Participants with reproductive potential must agree to use and follow medically approved contraceptive precautions during the study

Exclusion Criteria:

* Acute exacerbation of IPF within 6 months of Screening or during the Screening Period.
* Forced expiratory volume in 1 second (FEV1)/FVC ratio of \<0.7 at Screening.
* Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.
* Expected to receive a lung transplant within the study duration.
* Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening.
* Planned surgery within the study duration.
* Clinically significant pulmonary hypertension.
* 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.
* Use of systemic corticosteroids (prednisone or equivalent) at a dose ≥ 10 mg once daily within 30 days of Screening.
* Currently smoking or vaping.
* Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening.
* Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
* Currently pregnant, breast feeding, or planning to conceive for the length of the study.
* History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening.
* 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.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2× upper limit of normal (ULN) at Screening.
* Any other concurrent active medical condition determined by the Investigator to interfere with participant's ability to complete the trial.
* Known allergy to MTX-463 or any of its excipients.
* Any prior use of MTX-463 or other therapy targeting WISP1.
* Any other concurrent experimental agent or an active part of any other clinical trial, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer.

Where this trial is running

Birmingham, Alabama and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisMTX-463-I201MTX-463IPFAdultFibrosisMonoclonal AntibodyMAB
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.