Recruiting

Phase 2

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

Sponsor:

Mediar Therapeutics

Code:

NCT06967805

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

MTX-463

Placebo

Study Details

Brief 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)

Conditions

Idiopathic Pulmonary Fibrosis

Study ID

NCT06967805

Start date

May 5, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MTX-463

MTX-463

placebo comparator: Placebo

Placebo

Interventions

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

Primary outcome measure

To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC) [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

Jeffrey Bornstein, MD

(617) 936-0960 Jeffrey@mediartx.com

Katherine Palu

(617) 936-0960

Locations

WISPer Site in Birmingham, AL

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

WISPer Contact

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information