Testing MTX-463 against a placebo for idiopathic pulmonary fibrosis

Exclusion

• −Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic.
• −Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
• −Acute exacerbation of IPF within 6 months of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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.
• −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.
• −Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening.
• −History of severe depression, psychosis, or suicidal ideation, as determined by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.
• −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.
• −Currently pregnant, breast feeding, or planning to conceive for the length of the study.
• −Planned surgery within the study duration.
• −Currently smoking or vaping.