WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT06967805
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
164 participants
INTERVENTIONAL
2025-05-05
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MTX-463
MTX-463
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
Placebo
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Mediar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Todd Astor, MD
Role: STUDY_CHAIR
Mediar Therapeutics
Locations
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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 Champaign, IL
Champaign, Illinois, United States
WISPer site in Kansas City, KS
Kansas City, Kansas, United States
WISPer site in Shreveport, LA
Shreveport, Louisiana, United States
WISPer Site in Baltimore, MD
Baltimore, Maryland, United States
WISPer Site in Ann Arbor, MI
Ann Arbor, Michigan, United States
WISPer Site in Detroit, MI
Detroit, Michigan, United States
WISPer site in New York, NY
New York, New York, United States
WISPer Site in Durham, NC
Durham, North Carolina, United States
WISPer site in Greensboro, NC
Greensboro, North Carolina, United States
WISPer site in Oklahoma City, OK
Oklahoma City, Oklahoma, United States
WISPer Site in Nashville, TN
Nashville, Tennessee, United States
WISPer site in Dallas, TX
Dallas, Texas, United States
WISPer Site in Wilwaukee, WI
Milwaukee, Wisconsin, United States
WISPer site in Greenslopes, Australia
Greenslopes, , Australia
WISPer site in Melbourne, Australia
Melbourne, , Australia
WISPer site in Midland, Australia
Midland, , Australia
WISPer site in Westmead, Australia
Westmead, , Australia
WISPer Site in Calgary, Alberta
Calgary, Alberta, Canada
WISPer site in Ajax, ON
Ajax, Ontario, Canada
WISPer site in Trois-Rivières, Quebec
Trois-Rivières, Quebec, Canada
WISPer Site in Split
Split, , Croatia
WISPer Site in Birmingham, UK
Birmingham, , United Kingdom
WISPer Site in Cambridge, UK
Cambridge, , United Kingdom
WISPer Site in Edinburgh, UK
Edinburgh, , United Kingdom
WISPer Site in Oxford, UK
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-521278-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WISPer
Identifier Type: OTHER
Identifier Source: secondary_id
MTX-463-I201
Identifier Type: -
Identifier Source: org_study_id
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