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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• WISPer Site in Birmingham, AL, Birmingham, Alabama, United States
• WISPer site in Phoenix, AZ, Phoenix, Arizona, United States
• WISPer Site in Los Angeles, CA, Los Angeles, California, United States
• WISPer site in Newport Beach, CA, Newport Beach, California, United States
• WISPer Site in Palm Springs, CA, Palm Springs, California, United States
• WISPer Site in Denver, CO, Denver, Colorado, United States
• WISPer site in Loxahatchee, FL, Loxahatchee Groves, Florida, United States
• WISPer Site in Atlanta, GA, Atlanta, Georgia, United States
• WISPer site in Champaign, IL, Champaign, Illinois, United States
• WISPer site in Kansas City, KS, Kansas City, Kansas, United States
• WISPer Site in Louisville, KY, Louisville, Kentucky, United States
• WISPer site in Shreveport, LA, Shreveport, Louisiana, United States

+ 57 more sites.

Who to contact

Jeffrey Bornstein, MD · (617) 936-0960 · Jeffrey@mediartx.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06967805.