A Phase 2 interventional study of MTX-463 and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Mediar Therapeutics. Active, not recruiting at 59 sites in 11 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Mediar Therapeutics · Phase 2, Interventional, and Treatment
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Participants with IPF who meet the study's inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to receive MTX-463 or a matching placebo by intravenous (IV) infusion. Concomitant use of one of the approved IPF therapies, pifenidone, nintedanib, or nerandomilast, is permitted, and it is expected that about half the study population will be on one of those medications. Participants randomized to the MTX-463 arm of the study will receive an IV infusion every 4 weeks, beginning at Day 0 and ending at Week 20. The End of Treatment Visit will occur at Week 24, 4 weeks after the final infusion; and a final Safety Follow-Up Visit will occur at Week 28, 8 weeks after the final infusion. Assessments of FVC will occur at Screening, Baseline, and at all subsequent treatment visits up to and including Week 24. L-PF assessments will be performed at Baseline and Week 24. Participants will have blood drawn for safety assessment and to assess WISP1 levels at Baseline and every 4 weeks throughout the study. Blood will be drawn for serum PK analyses relative to the first and last doses of MTX-463.
576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.
This study's enrollment of 168 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Mediar Therapeutics is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MTX-463
Biological: MTX-463
Placebo
Other: Placebo
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
To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)
Change from Baseline to Week 24 in Forced Vital Capacity (FVC)
Time frame: 24 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent adverse events
Incidence of treatment-emergent adverse events (TEAEs) from Baseline until Week 28 in each group
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment related adverse events
Incidence of treatment related adverse events from Baseline until Week 28 in each group
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of serious treatment emergent adverse events
Incidence of serious treatment emergent adverse events from Baseline until Week 28 in each group
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of severe treatment emergent adverse events
Incidence of severe treatment emergent adverse events from Baseline until week 28 in each group
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent abnormalities on clinical laboratory tests
Incidence of treatment emergent abnormalities on clinical laboratory tests from Baseline until Week 28 in each group
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of abnormal findings on physical exam
Incidence of abnormal findings on physical exam from baseline until Week 28 in each group
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment discontinuations
Incidence of treatment discontinuations from Baseline until Week 28 in each group
Time frame: 28 Weeks
To assess the effect of MTX-463 on the change from Baseline in the percent predicted FVC (FVCpp)
Change from Baseline to Week 24 in the percent predicted FVC (FVCpp)
Time frame: 24 Weeks
To collect sparse pharmacokinetics (PK) of MTX-463 in participants with IPF
Samples will be collected from Baseline until Week 24 to assess the trough serum concentrations of the study drug
Time frame: 24 Weeks
To assess the development of antidrug antibodies (ADA) against MTX-463
Samples will be collected from Baseline until Week 28 to assess the rate at which antibodies develop to the study drug
Time frame: 28 Weeks
To assess the effect of MTX-463 on the change from Baseline in FVC in participants on concomitant pirfenidone, nintedanib, or nerandomilast
The change from Baseline to week 24 in the mean FVC (in ML) will be measured in each group in the subset of participants who enter the study on background IPF medications, pirfenidone, nintedanib, or nerandomilast
Time frame: 24 Weeks
To assess the effect of MTX-463 on the change from Baseline in FVC in participants not on concomitant pirfenidone, nintedanib, or nerandomilast
The change from baseline to week 24 in the mean FVC (in ML) will be measured in each group in the subset of participants who enter the study not on any background IPF medications, pirfenidone, nintedanib, or nerandomilast
Time frame: 24 Weeks
To assess the effect of MTX-463 on the change from Baseline in the Living with Pulmonary Fibrosis (L-PF) Questionnaire total score
Change from Baseline to Week 24 in L-PF total score. The L-PF is scored on a scale of 0-100, with higher numbers indicating greater impairment.
Time frame: 24 Weeks
To assess whether serum WNT-inducible signaling pathway protein 1 (WISP1) levels at Screening predict improved outcomes with MTX-463 treatment
* Change from Baseline to Week 24 in total WISP1 levels * Change from Baseline to Week 24 in free WISP1 levels * Change from Baseline to Week 24 in FVC by free and total WISP1 screening quartiles
Time frame: 24 Weeks
To assess the effect of MTX-463 on the change from Baseline in percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO)
Change from Baseline to Week 24 in percent predicted DLCO
Time frame: 24 Weeks
To evaluate the time to disease progression as determined by change in FVC, IPF-related changes, or death
Time to disease progression with progression being defined as ≥10% decline in FVC from Baseline, IPF related hospitalization, or death
Time frame: 28 Weeks
To assess the effect of MTX-463 on the PROLIFIC panel of biomarkers
The mean change from Baseline to Week 24 in the level of each PROLIFIC panel biomarker (MMP-7, SP-D, KL-6, PAI-1, CA-19-9, CYFRA 21-1, CXCL13, sICAM1, CCL18, POSTN, CA-125, and TNC) in the serum will be measured in each group
Time frame: 24 Weeks
To assess the effect of MTX-463 on biomarkers of IPF
The mean change from Baseline to Week 24 in the levels of each biomarker of IPF (TIMP-1, CCL2, Pro-C3, Pro-C6, C7M, and IL-6) in the serum will be measured in each group
Time frame: 24 Weeks
To assess the effect of MTX-463 on biomarkers of bone remodeling
The mean change from Baseline to Week 24 in the levels of each biomarker of bone remodeling (procollagen type 1 N-terminal propeptide \[P1NP\] and C-terminal cross-linked telopeptide of type 1 collagen \[CTX\])
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MTX-463
Idiopathic Pulmonary Fibrosis →
Mediar Therapeutics