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Active, not recruiting Phase 2

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

NCT06967805 · tracked via the Priya Life Science UK tracker
Phase
Phase 2
Started
2025-05-05
Last updated
2026-10-15

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

MTX-463Placebo

MTX-463: MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.

Placebo: Placebo

Study summary

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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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 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 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. * 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.

Primary outcome measure(s)

  • 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)

Trial sites (59)

FacilityCityRegionStatus
WISPer Site in Birmingham, AL Birmingham Alabama
WISPer site in Phoenix, AZ Phoenix Arizona
WISPer site in Newport Beach, CA Newport Beach California
WISPer Site in Palm Springs, CA Palm Springs California
WISPer Site in Denver, CO Denver Colorado
WISPer site in Loxahatchee, FL Loxahatchee Groves Florida
WISPer Site in Atlanta, GA Atlanta Georgia
WISPer site in Champaign, IL Champaign Illinois
WISPer site in Kansas City, KS Kansas City Kansas
WISPer site in Shreveport, LA Shreveport Louisiana
WISPer Site in Baltimore, MD Baltimore Maryland
WISPer Site in Boston, MA Boston Massachusetts
WISPer Site in Ann Arbor, MI Ann Arbor Michigan
WISPer site in New York, NY New York New York
WISPer Site in Durham, NC Durham North Carolina
WISPer site in Greensboro, NC Greensboro North Carolina
WISPer site in Oklahoma City, OK Oklahoma City Oklahoma
WISPer Site in Pittsburgh, PA Pittsburgh Pennsylvania
WISPer Site in Charleston, SC Charleston South Carolina
WISPer site in Dallas, TX Dallas Texas
WISPer Site in Salt Lake City, UT Salt Lake City Utah
WISPer Site in Milwaukee, WI Milwaukee Wisconsin
WISPer Site in Buenos Aires, Argentina Buenos Aires Argentina
WISPer Site in Buenos Aires, Argentina Buenos Aires Argentina
WISPer Site in Cordoba, Argentina Córdoba Argentina
WISPer Site in Mendoza, Argentina Mendoza Argentina
WISPer Site in San Miguel De Tucumán, Argentina San Miguel de Tucumán Argentina
WISPer site in Melbourne, Australia Melbourne Australia
WISPer site in Midland, Australia Midland Australia
WISPer site in Westmead, Australia Westmead Australia
WISPer Site in Brussels, Belgium Brussels Belgium
WISPer Site in Edegem, Belgium Edegem Belgium
WISPer Site in Belo Horizonte, Brazil Belo Horizonte Brazil
WISPer Site in Curitiba, Brazil Curitiba Brazil
WISPer Site in Passo Fundo, Brazil Passo Fundo Brazil
WISPer Site in Porto Alegre, Brazil Porto Alegre Brazil
WISPer Site in São Bernardo Do Campo, Brazil São Bernardo do Campo Brazil
WISPer Site in Sao Paulo, Brazil São Paulo Brazil
WISPer Site in Calgary, Alberta Calgary Alberta
WISPer site in Ajax, ON Ajax Ontario

+ 19 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06967805 on ClinicalTrials.gov ↗ ← All trials in the UK