MTX-463 for Idiopathic pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- 1.\tParticipants with IPF of any gender ≥40 years of age at time of signing the informed consent"}
• {"criterion_text":"- 10. 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"}
• {"criterion_text":"- 11. 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"}
• {"criterion_text":"- 2.\tAble to understand the study and provide signed, written informed consent"}
• {"criterion_text":"- 3.\tAble to read and understand the language of the informed consent and other study related materials"}
• {"criterion_text":"- 4.\tMeet 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"}
• {"criterion_text":"- 5. 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."}
• {"criterion_text":"- 6. 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."}
• {"criterion_text":"- 7.\tFVC of ≥45 percent predicted (pp) at Screening"}
• {"criterion_text":"- 8.\tDLCO of ≥25 pp at Screening"}
• {"criterion_text":"- 9.\tWilling and able to complete all protocol required study visits and procedures"}

Exclusion criteria

• {"criterion_text":"- 1.\tAcute exacerbation of IPF within 6 months of Screening or during the Screening Period"}
• {"criterion_text":"- 10.\tCurrently smoking or vaping"}
• {"criterion_text":"- 11.\tCurrent known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening"}
• {"criterion_text":"- 12.\tCurrent infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)"}
• {"criterion_text":"- 13.\tCurrently pregnant, breast feeding, or planning to conceive for the length of the study"}
• {"criterion_text":"- 14.\tHistory of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening"}
• {"criterion_text":"- 15.\tAny 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"}
• {"criterion_text":"- 16.\tAspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upper limit of normal (ULN) at Screening"}
• {"criterion_text":"- 17. 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"}
• {"criterion_text":"- 18. Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody"}
• {"criterion_text":"- 19.\tAny prior use of MTX-463 or other therapy targeting WISP1"}
• {"criterion_text":"- 2.\tForced expiratory volume in 1 second (FEV1)/FVC ratio of < 0.7 at Screening"}
• {"criterion_text":"- 20. 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"}
• {"criterion_text":"- 3.\tRequirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted"}
• {"criterion_text":"- 4.\tExpected to receive a lung transplant within the study duration"}
• {"criterion_text":"- 5.\tCurrent active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening"}
• {"criterion_text":"- 6.\tPlanned surgery within the study duration"}
• {"criterion_text":"- 7.\tClinically significant pulmonary hypertension"}
• {"criterion_text":"- 8.\tUse 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."}
• {"criterion_text":"- 9.\tUse of systemic corticosteroids (prednisone or equivalent) at a dose >10 mg once daily within 30 days of Screening"}

Primary endpoints

• {"endpoint_text":"- Change from Baseline to Week 24 in FVC","definition_or_measurement_approach":"Change from baseline measured in forced vital capacity (FVC) at baseline and at Week 24"}

Secondary endpoints

• {"endpoint_text":"- Incidence, seriousness, and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs); and incidence of dose interruptions and discontinuations •\tClinically significant findings on physical examinations, vital signs, and clinical laboratory tests","definition_or_measurement_approach":"Safety outcomes: collection and reporting of TEAEs and TRAEs, dose interruptions/discontinuations, clinically significant findings from physical exams, vital signs and lab tests"}
• {"endpoint_text":"- Change from Baseline to Week 24 in the FVCpp","definition_or_measurement_approach":"Change from baseline in percent predicted FVC measured at baseline and at Week 24"}
• {"endpoint_text":"- Sparse PK profiles will be evaluated by population PK analyses","definition_or_measurement_approach":"Collection of sparse pharmacokinetic samples analyzed using population PK methods"}

Methods

• Patient Advocacy Strategies: Advertising, Recruitment, and Patient Retention (contracted third party listed in sponsor third parties)
• Propharma Group LLC: Investigator recruitment support, on-site monitoring and project management responsibilities (explicitly listed duties include Investigator Recruitment)
• Use of country-specific recruitment arrangements documents (K1) submitted for each participating country (documents titled 'Recruitment arrangements' present for BE, ES, NL, IE, FR, HR)
• Pre-ICF telephone contact (Pre-ICF Telephone Data Consent documents listed) and Scout Clinical involvement for patient payments/travel concierge

Belgium

Earliest CTIS Part Ii Submission Date

14-08-2025

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

76

Number Of Sites

2

Number Of Participants

6

Croatia

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

06-10-2025

Processing Time Days

47

Number Of Sites

2

Number Of Participants

6

Netherlands

Earliest CTIS Part Ii Submission Date

02-09-2025

Latest Decision Or Authorization Date

02-10-2025

Processing Time Days

30

Number Of Sites

2

Number Of Participants

6

France

Earliest CTIS Part Ii Submission Date

04-08-2025

Latest Decision Or Authorization Date

06-10-2025

Processing Time Days

63

Number Of Sites

4

Number Of Participants

10

Ireland

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

03-10-2025

Processing Time Days

44

Number Of Sites

4

Number Of Participants

16

Primary sponsor

Full Name

Mediar Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Propharma Group LLC

Responsibilities

On site monitoring, Investigator Recruitment, Project management, Data management, E-Data capture, Safety reporting, Q/A auditing, Statistical Analysis, Medical Writing, Regulatory expertise, Medical expertise

Third parties

• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"Central Laboratory; code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"On site monitoring, Investigator Recruitment, Project management, Data management, E-Data capture, Safety reporting, Q/A auditing, Statistical Analysis, Medical Writing, Regulatory expertise, Medical expertise","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Xerimis Inc.","duties_or_roles":"IP Supply Management and Distribution","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Patient Advocacy Strategies","duties_or_roles":"Advertising, Recruitment, and Patient Retention","organisation_type":"SME"}
• {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Zephyrx LLC","duties_or_roles":"Speriometry","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient payments and travel concierge","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"FluidDa","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}