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WISPer: MTX-463 for Idiopathic Pulmonary Fibrosis (IPF)

This study is testing a new treatment called MTX-463 for people with Idiopathic Pulmonary Fibrosis (IPF), a chronic lung disease. MTX-463 is a type of antibody that targets a protein called WISP1, which is often found in higher levels in people with IPF. The study aims to see if MTX-463 can help improve lung function, specifically by measuring changes in forced vital capacity (FVC) after 24 weeks. You may be able to join if you are 40 years or older with IPF. About 164 people are expected to participate. The current recruitment status is unclear.

Study design
This is a Phase 2a, randomized, double-blind, placebo-controlled study. Participants will be randomly assigned to receive either MTX-463 or a placebo, with about 164 people expected to enroll.
What's involved
You would receive intravenous (IV) infusions every 4 weeks for 20 weeks. You would have visits for assessments of lung function (FVC), blood draws for safety and WISP1 levels, and other tests.
Compensation
Not stated in the trial record.
Follow-up
After your last infusion at Week 20, there will be an End of Treatment Visit at Week 24 and a final Safety Follow-Up Visit at Week 28.

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NCT06967805

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Recruiting
PHASE2Ages 40+InterventionalTreatment
Mediar Therapeutics
~164 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:MTX-463Placebo

At a glance

Recruiting sites
71 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)
Measured over 24 Weeks

Conditions

Idiopathic Pulmonary Fibrosis

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Idiopathic Pulmonary Fibrosis

NCT06967805

Where you'd take part

This study runs at 71 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • WISP Site in São Bernardo Do Campo, Brazil

    São Bernardo do Campo, Brazilstudy coordinator listed

    Recruiting

  • WISPer Site in Abbotstown, Ireland

    Abbotstown, Irelandstudy coordinator listed

    Recruiting

  • WISPer site in Ajax, ON

    Ajax, Ontario, Canadastudy coordinator listed

    Recruiting

  • WISPer Site in Ann Arbor, MI

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • WISPer Site in Atlanta, GA

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • WISPer Site in Baltimore, MD

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • WISPer Site in Barcelona, Spain

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • WISPer Site in Barcelona, Spain

    Barcelona, Spainstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Todd Astor, MD · STUDY_CHAIR · Mediar Therapeutics

Who to contact

Jeffrey Bornstein, MD
[email protected]
(617) 936-0960 · ext. 803
Email the study team

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Eligibility criteria

Inclusion

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 study-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, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study. Use of any of these 3 agents in combination with each other is not permitted.
If a participant was on treatment with pirfenidone, nintedanib, 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 either 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.
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.
Female 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 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.
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.

Exclusion

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.
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 trial.
Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic.
Any prior use of MTX-463 or other therapy targeting WISP1.
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.

What this trial measures

  • To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)24 Weeks

    Change from Baseline to Week 24 in Forced Vital Capacity (FVC)