Overview

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

Eligibility

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.