Idiopathic Pulmonary FibrosisPhase 2NCT06967805
WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing MTX-463 in people with Idiopathic Pulmonary Fibrosis, run by Mediar Therapeutics at 59 sites in 11 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- MTX-463
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 59 sitesin 11 countries
- Study dates
- 5 May 2025to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
59 sites in 11 countries.
59 sites in 11 countries
United States22 sites
WISPer Site in Ann Arbor, MI
Ann Arbor, Michigan, 48209
WISPer Site in Atlanta, GA
Atlanta, Georgia, 30322
WISPer Site in Baltimore, MD
Baltimore, Maryland, 21224
WISPer Site in Birmingham, AL
Birmingham, Alabama, 35233
WISPer Site in Boston, MA
Boston, Massachusetts, 02114
WISPer site in Champaign, IL
Champaign, Illinois, 61822
WISPer Site in Charleston, SC
Charleston, South Carolina, 29425
WISPer site in Dallas, TX
Dallas, Texas, 75204
WISPer Site in Denver, CO
Denver, Colorado, 80206
WISPer Site in Durham, NC
Durham, North Carolina, 27710
WISPer site in Greensboro, NC
Greensboro, North Carolina, 27403
WISPer site in Kansas City, KS
Kansas City, Kansas, 66160
WISPer site in Loxahatchee, FL
Loxahatchee Groves, Florida, 33470
WISPer Site in Milwaukee, WI
Milwaukee, Wisconsin, 53226
WISPer site in New York, NY
New York, New York, 10032
WISPer site in Newport Beach, CA
Newport Beach, California, 92663
WISPer site in Oklahoma City, OK
Oklahoma City, Oklahoma, 73104
WISPer Site in Palm Springs, CA
Palm Springs, California, 92262
WISPer site in Phoenix, AZ
Phoenix, Arizona, 85032
WISPer Site in Pittsburgh, PA
Pittsburgh, Pennsylvania, 15213
WISPer Site in Salt Lake City, UT
Salt Lake City, Utah, 84103
WISPer site in Shreveport, LA
Shreveport, Louisiana, 71103
Brazil6 sites
WISPer Site in Belo Horizonte, Brazil
Belo Horizonte, 30110
WISPer Site in Curitiba, Brazil
Curitiba, 80060
WISPer Site in Passo Fundo, Brazil
Passo Fundo, 99010
WISPer Site in Porto Alegre, Brazil
Porto Alegre, 90035
WISPer Site in São Bernardo Do Campo, Brazil
São Bernardo do Campo, 09715
WISPer Site in Sao Paulo, Brazil
São Paulo, 05403
Argentina5 sites
WISPer Site in Buenos Aires, Argentina
Buenos Aires, B1602DQD
WISPer Site in Buenos Aires, Argentina
Buenos Aires, C1199ABB
WISPer Site in Cordoba, Argentina
Córdoba, X5003DCE
WISPer Site in Mendoza, Argentina
Mendoza, M5500
WISPer Site in San Miguel De Tucumán, Argentina
San Miguel de Tucumán, T4000IAI
Spain5 sites
WISPer Site in Barcelona, Spain
Barcelona, 08017
WISPer Site in Barcelona, Spain
Barcelona, 08036
WISPer Site in Lugo, Spain
Lugo, 27003
WISPer Site in Madrid, Spain
Madrid, 28223
WISPer Site in Santander, Spain
Santander, 39008
Ireland4 sites
WISPer Site in Abbotstown, Ireland
Abbotstown, D15 X40D
WISPer Site in Drogheda, Ireland
Drogheda, A92VW28
WISPer Site in Dublin, Ireland
Dublin, D24 NR0A
WISPer Site in Letterkenny, Ireland
Letterkenny, F92 AE81
United Kingdom4 sites
WISPer Site in Birmingham, UK
Birmingham, B15 2GW
WISPer Site in Cambridge, UK
Cambridge, CB2 0BB
WISPer Site in Edinburgh, UK
Edinburgh, EH16 4SA
WISPer Site in Oxford, UK
Oxford, OX3 7LE
Australia3 sites
WISPer site in Melbourne, Australia
Melbourne, 3004
WISPer site in Midland, Australia
Midland, 6056
WISPer site in Westmead, Australia
Westmead, 2145
Canada3 sites
WISPer site in Ajax, ON
Ajax, Ontario, L1S 2J5
WISPer Site in Calgary, Alberta
Calgary, Alberta, T2N 4Z5
WISPer site in Trois-Rivières, Quebec
Trois-Rivières, Quebec, G8T 7A1
France3 sites
WISPer Site in Nantes, France
Nantes, 44800
WISPer Site in Nice, France
Nice, 06001
WISPer Site in Rennes, France
Rennes, 35033
Belgium2 sites
WISPer Site in Brussels, Belgium
Brussels, 1200
WISPer Site in Edegem, Belgium
Edegem, 2650
Netherlands2 sites
WISPer Site in Nieuwegein, Netherlands
Nieuwegein, 3435CM
WISPer Site in Rotterdam, Netherlands
Rotterdam, 3015AA
About this study
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)
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Read the detailed description
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- MTX-463, Placebo
- Keywords
- MTX-463-I201, MTX-463, IPF, Idiopathic Pulmonary Fibrosis, Adult, Fibrosis, Monoclonal Antibody, MAB, FVC, WISPer
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX-463Biological
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.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MTX-463 | Experimental | MTX-463 Receives: Biological: MTX-463 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 Weeks
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 May 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mediar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Astor, MD, Study chair, Mediar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967805
- Sponsor's protocol ID
- MTX-463-I201
- Other IDs
- 2025-521278-32, WISPer, 2025
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06967805
- Acronym / sponsor ID
- MTX-463-I201
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- MTX-463-I201, MTX-463, IPF, Idiopathic Pulmonary Fibrosis, Adult, Fibrosis, Monoclonal Antibody, MAB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mediar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX-463 | Experimental | Biological: MTX-463MTX-463 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX-463MTX-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. | Biological | MTX-463 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)
Time frame: 24 Weeks
Change from Baseline to Week 24 in Forced Vital Capacity (FVC)
9 secondary outcomes
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent adverse events
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
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
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
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
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
Time frame: 28 Weeks
To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment discontinuations
Time frame: 28 Weeks
To assess the effect of MTX-463 on the change from Baseline in the percent predicted FVC (FVCpp)
Time frame: 24 Weeks
To collect sparse pharmacokinetics (PK) of MTX-463 in participants with IPF
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Astor, MD study chair
Mediar Therapeutics
59 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTX-463 in people with Idiopathic Pulmonary Fibrosis, run by Mediar Therapeutics at 59 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Brazil, Argentina, Spain, Ireland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC) (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.