Evaluation of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mediar Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

4 Dec 2025 → ongoing

Decision date (initial)

2025-10-01

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Mediar Therapeutics

External identifiers

EU CT number

2025-521278-32-00

ClinicalTrials.gov

NCT06967805

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Pharmacokinetic, Efficacy

To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)

Secondary objectives 3

1. To assess the safety and tolerability of MTX 463 in participants with IPF
2. To assess the effect of MTX-463 on the change from Baseline in the percent predicted FVC (FVCpp)
3. To collect sparse pharmacokinetics (PK) of MTX-463 in participants with IPF

Conditions and MedDRA coding

Idiopathic Pulmonary Fibrosis (IPF)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. 1. Participants with IPF of any gender ≥40 years of age at time of signing the informed consent
2. 2. Able to understand the study and provide signed, written informed consent
3. 3. Able to read and understand the language of the informed consent and other study related materials
4. 4. 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
5. 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.
6. 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.
7. 7. FVC of ≥45 percent predicted (pp) at Screening
8. 8. DLCO of ≥25 pp at Screening
9. 9. Willing and able to complete all protocol required study visits and procedures
10. 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
11. 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

Exclusion criteria 20

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline to Week 24 in FVC

Secondary endpoints 3

1. Incidence, seriousness, and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs); and incidence of dose interruptions and discontinuations • Clinically significant findings on physical examinations, vital signs, and clinical laboratory tests
2. Change from Baseline to Week 24 in the FVCpp
3. Sparse PK profiles will be evaluated by population PK analyses

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mediar Therapeutics Inc.

Sponsor organisation

Mediar Therapeutics Inc.

Address

20 Overland Street Suite 520

City

Boston

Postcode

02215-3336

Country

United States

Scientific contact point

Organisation

Mediar Therapeutics Inc.

Contact name

Mediar Clinical Study Information

Public contact point

Organisation

Mediar Therapeutics Inc.

Contact name

Mediar Clinical Study Information

Third parties 13

Locations

6 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications