RECRUITING

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

Conditions

Idiopathic Pulmonary Fibrosis MTX-463-I201 MTX-463 IPF Adult Fibrosis Monoclonal Antibody MAB FVC WISPer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Official Title

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Quick Facts

Study Start:2025-05

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06967805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	* 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. * 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.

Inclusion Criteria

Exclusion 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 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

* 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.
* 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.

Contacts and Locations

Study Contact

Jeffrey Bornstein, MD

CONTACT

6176203403

jeffrey@mediartx.com

Principal Investigator

Pablo Zertuche, MD

STUDY_CHAIR

Mediar Therapeutics

Study Locations (Sites)

NewportNativeMD

Newport Beach, California, 92663

United States

Advanced Pulmonary Research Institute

Loxahatchee, Florida, 33470

United States

Collaborators and Investigators

Sponsor: Mediar Therapeutics

Pablo Zertuche, MD, STUDY_CHAIR, Mediar Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-05

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

MTX-463-I201
MTX-463
IPF
Idiopathic Pulmonary Fibrosis
Adult
Fibrosis
Monoclonal Antibody
MAB
FVC
WISPer

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis