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New antibody drug aims to slow lung scarring in IPF

NCT ID NCT06967805

Disease control Sponsor: Mediar Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether MTX-463, an antibody that blocks a protein linked to scarring, can slow lung function decline in people with idiopathic pulmonary fibrosis (IPF). About 164 adults with IPF will receive either the drug or a placebo for 24 weeks. The main goal is to see if the drug improves forced vital capacity, a measure of lung function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MTX-463 (a monoclonal antibody)
What this could lead to
If successful, this could point toward a new treatment to slow lung function decline in people with idiopathic pulmonary fibrosis.
What could go wrong
This is an early phase 2 trial with only 164 participants, so results may not confirm effectiveness. The drug may cause side effects or fail to improve breathing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

Fibrosis idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    71 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • WISP Site in São Bernardo Do Campo, Brazil

    RECRUITING

    São Bernardo do Campo, 09715, Brazil

  • WISPer Site in Abbotstown, Ireland

    RECRUITING

    Abbotstown, D15 X40D, Ireland

  • WISPer Site in Ann Arbor, MI

    RECRUITING

    Ann Arbor, Michigan, 48209, United States

  • WISPer Site in Atlanta, GA

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • WISPer Site in Baltimore, MD

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • WISPer Site in Barcelona, Spain

    RECRUITING

    Barcelona, 08017, Spain

  • WISPer Site in Barcelona, Spain

    RECRUITING

    Barcelona, 08036, Spain

  • WISPer Site in Barcelona, Spain

    RECRUITING

    Barcelona, 08908, Spain

  • WISPer Site in Belo Horizonte, Brazil

    RECRUITING

    Belo Horizonte, 30110, Brazil

  • WISPer Site in Birmingham, AL

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • WISPer Site in Birmingham, UK

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • WISPer Site in Boston, MA

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • WISPer Site in Brussels, Belgium

    RECRUITING

    Brussels, 1200, Belgium

  • WISPer Site in Buenos Aires, Argentina

    RECRUITING

    Buenos Aires, B1602DQD, Argentina

  • WISPer Site in Calgary, Alberta

    RECRUITING

    Calgary, Alberta, T2N 4Z5, Canada

  • WISPer Site in Cambridge, UK

    RECRUITING

    Cambridge, CB2 0BB, United Kingdom

  • WISPer Site in Charleston, SC

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • WISPer Site in Cordoba, Argentina

    RECRUITING

    Córdoba, X5003DCE, Argentina

  • WISPer Site in Curitiba, Brazil

    RECRUITING

    Curitiba, 80060, Brazil

  • WISPer Site in Denver, CO

    RECRUITING

    Denver, Colorado, 80206, United States

  • WISPer Site in Detroit, MI

    RECRUITING

    Detroit, Michigan, 48202, United States

  • WISPer Site in Drogheda, Ireland

    RECRUITING

    Drogheda, F92VW28, Ireland

  • WISPer Site in Dublin, Ireland

    RECRUITING

    Dublin, D24 NR0A, Ireland

  • WISPer Site in Durham, NC

    RECRUITING

    Durham, North Carolina, 27710, United States

  • WISPer Site in Edegem, Belgium

    RECRUITING

    Edegem, 2650, Belgium

  • WISPer Site in Edinburgh, UK

    RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • WISPer Site in Letterkenny, Ireland

    RECRUITING

    Letterkenny, F92 AE81, Ireland

  • WISPer Site in Los Angeles, CA

    RECRUITING

    Los Angeles, California, 90033, United States

  • WISPer Site in Louisville, KY

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • WISPer Site in Lugo, Spain

    RECRUITING

    Lugo, 27003, Spain

  • WISPer Site in Madrid, Spain

    RECRUITING

    Madrid, 28223, Spain

  • WISPer Site in Madrid, Spain 2

    RECRUITING

    Madrid, 28050, Spain

  • WISPer Site in Mendoza, Argentina

    RECRUITING

    Mendoza, M5500, Argentina

  • WISPer Site in Nantes, France

    RECRUITING

    Nantes, 44800, France

  • WISPer Site in Nashville, TN

    RECRUITING

    Nashville, Tennessee, 37204, United States

  • WISPer Site in Nice, France

    RECRUITING

    Nice, 06001, France

  • WISPer Site in Nieuwegein, Netherlands

    RECRUITING

    Nieuwegein, 3435CM, Netherlands

  • WISPer Site in Oxford, UK

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • WISPer Site in Palm Springs, CA

    RECRUITING

    Palm Springs, California, 92203, United States

  • WISPer Site in Paris, France

    RECRUITING

    Paris, 75015, France

  • WISPer Site in Passo Fundo, Brazil

    RECRUITING

    Passo Fundo, 99010, Brazil

  • WISPer Site in Pittsburg, PA

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • WISPer Site in Porto Alegre, Brazil

    RECRUITING

    Porto Alegre, 90035, Brazil

  • WISPer Site in Porto Alegre, Brazil

    RECRUITING

    Porto Alegre, 90410, Brazil

  • WISPer Site in Rennes, France

    RECRUITING

    Rennes, 35033, France

  • WISPer Site in Rosario, Argentina

    RECRUITING

    Rosario, S2000DBS, Argentina

  • WISPer Site in Rotterdam, Netherlands

    RECRUITING

    Rotterdam, 3015, Netherlands

  • WISPer Site in Salt Lake City, UT

    RECRUITING

    Salt Lake City, Utah, 84103, United States

  • WISPer Site in San Miguel De Tucumán, Argentina

    RECRUITING

    San Miguel de Tucumán, T4000IAI, Argentina

  • WISPer Site in Santa Fe, Argentina

    RECRUITING

    Santa Fe, S2000DBS, Argentina

  • WISPer Site in Santa Fe, Argentina

    RECRUITING

    Santa Fe, S3000ASF, Argentina

  • WISPer Site in Santander, Spain

    RECRUITING

    Santander, 39008, Spain

  • WISPer Site in Sao Paulo, Brazil

    RECRUITING

    São Paulo, 05403, Brazil

  • WISPer Site in Split

    RECRUITING

    Split, 21000, Croatia

  • WISPer Site in Wilwaukee, WI

    RECRUITING

    Milwaukee, Wisconsin, 52226, United States

  • WISPer site in Ajax, ON

    RECRUITING

    Ajax, Ontario, L1S 2J5, Canada

  • WISPer site in Champaign, IL

    RECRUITING

    Champaign, Illinois, 61822, United States

  • WISPer site in Dallas, TX

    RECRUITING

    Dallas, Texas, 75204, United States

  • WISPer site in Greensboro, NC

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • WISPer site in Greenslopes, Australia

    RECRUITING

    Greenslopes, 4120, Australia

  • WISPer site in Kansas City, KS

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • WISPer site in Loxahatchee, FL

    RECRUITING

    Loxahatchee Groves, Florida, 33470, United States

  • WISPer site in Melbourne, Australia

    RECRUITING

    Melbourne, 3004, Australia

  • WISPer site in Midland, Australia

    RECRUITING

    Midland, 6056, Australia

  • WISPer site in New York, NY

    RECRUITING

    New York, New York, 10032, United States

  • WISPer site in Newport Beach, CA

    RECRUITING

    Newport Beach, California, 92663, United States

  • WISPer site in Oklahoma City, OK

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • WISPer site in Phoenix, AZ

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • WISPer site in Shreveport, LA

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • WISPer site in Trois-Rivières, Quebec

    RECRUITING

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • WISPer site in Westmead, Australia

    RECRUITING

    Westmead, 2145, Australia

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