RecruitingPhase 2NCT06967805
WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor
Mediar Therapeutics
Enrollment
164 participants
Start Date
May 5, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 40 Years
Inclusion Criteria12
- 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 Criteria20
- 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.
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Interventions
BIOLOGICALMTX-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.
OTHERPlacebo
Placebo
Locations(69)
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NCT06967805
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