Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MTX-463 Efficacy and Safety in Idiopathic Pulmonary Fibrosis Patients
- Trial ID
- 2025-521278-32-00
- Protocol
- MTX-463-I201
- Sponsor
- Mediar Therapeutics Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the effect of MTX-463 on the change from baseline in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF). The secondary objectives include:
- Assessment of the safety and tolerability of MTX-463.
- Evaluation of the effect of MTX-463 on the change from baseline in the percent predicted FVC (FVCpp).
- Collection of sparse pharmacokinetics (PK) of MTX-463.
Participants
This clinical trial involves 106 participants diagnosed with idiopathic pulmonary fibrosis. The study population includes both male and female patients aged 40 years or older. Eligible individuals must meet the 2019 diagnostic criteria from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, or Latin American Thoracic Association. Required clinical parameters include a forced vital capacity of at least 45 percent predicted and a diffusing capacity of the lungs for carbon monoxide of at least 25 percent predicted. Participants receiving pirfenidone or nintedanib must have maintained a stable dose for at least 90 days prior to screening, and the concurrent use of both agents is prohibited. Individuals of childbearing potential must demonstrate a negative serum pregnancy test and adhere to highly effective contraception methods for the duration of the study and a specified period following the final dose.
Plans and Procedures
This Phase 2, randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of MTX-463 in individuals diagnosed with idiopathic pulmonary fibrosis. The primary objective is to assess the change from baseline in forced vital capacity (FVC) at 24 weeks. Participants will receive either MTX-463 via intravenous use at a dose of 28 mg/kg or a placebo consisting of 0.9% sodium chloride or 5% dextrose solution for infusion. The research methodology includes a screening visit to confirm eligibility based on criteria such as age, diagnosis, forced vital capacity percent predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO). Following screening, participants undergo the treatment period and subsequent follow-up assessments. Secondary endpoints include the incidence of treatment-emergent adverse events, dose interruptions, and pharmacokinetics profiles. Participation involves adherence to medically approved contraception methods during treatment and for a specified period following the final dose. The study is estimated to continue through May 2028.
Treatment
The experimental treatment consists of MTX-463, provided as a solution for injection. The administration involves an intravenous route at a dosage of 28 mg/kg.
The control group receives a placebo consisting of either sodium chloride 0.9% or glucose monohydrate (DEXTROSE/VIOSER 5% w/v), both administered as a solution for infusion.
Efficacy
The primary efficacy endpoint is the change from baseline in forced vital capacity (FVC) to Week 24. Secondary efficacy parameters include the change from baseline in FVCpp at Week 24 and the evaluation of sparse PK profiles via population PK analyses.
Inclusion and Exclusion Criteria
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 (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), or Latin American Thoracic Association (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, and there should be a plan to maintain the same dose throughout the study Treatment Period. Use of any of these 3 agents in combination with each other is not permitted.
- If a participant was on treatment with nintedanib, pirfenidone, 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 any 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 ≥25 pp 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 and 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 study
- Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody
- 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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Recruiting | 15 Sept 2025 | 6 |
 Croatia | Recruiting | 15 Sept 2025 | 6 |
 France | Recruiting | 15 Sept 2025 | 10 |
 Ireland | Recruiting | 15 Sept 2025 | 16 |
 The Netherlands | Recruiting | 15 Sept 2025 | — |
 Spain | Recruiting | 15 Sept 2025 | 14 |
| Netherlands | — | — | 6 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
NaCl 0,9 % B. Braun, solution pour perfusion | Placebo | SOLUTION POUR PERFUSION | SOLUTION FOR INFUSION | 0 | 20 | PRD5372757 |
DEXTROSE/VIOSER 5% w/v Solution for Infusion | Placebo | SOLUTION FOR INFUSION | SOLUTION FOR INFUSION | 0 | 20 | PRD10514487 |