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Looking for participantsPhase2

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor: Mediar Therapeutics

NCT ID: NCT06967805

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MTX-463 (biological), Placebo (other)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
MTX-463 — biological: MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). · Placebo — other: Placebo
Patient visit burden
Not specified by the sponsor

In plain English

This study, called WISPer, is testing a new medicine called MTX-463 in people with idiopathic pulmonary fibrosis (IPF), a condition where the lungs become scarred and breathing gets harder. The trial is paid for (sponsored) by Mediar Therapeutics. It aims to see how MTX-463 affects people with IPF.

Who can take part

  • Age 40 or over, any gender, with idiopathic pulmonary fibrosis (IPF) diagnosed within the last 7 years
  • Able to understand the study and give written informed consent
  • Lung function test results above certain levels at screening (FVC at least 45% predicted and DLCO at least 25% predicted)
  • If taking pirfenidone, nintedanab or nerandomilast, the dose must have been stable for at least 90 days before screening, with no plan to change it during the study; these medicines cannot be combined with each other
  • If these medicines were stopped, this must have been at least 30 days before screening, with no plan to restart them during the study
  • Able and willing to attend all study visits and complete all study procedures
  • People who could have children must use highly effective contraception during treatment and for up to 125 days after the last dose, whichever is longer
  • Women who could become pregnant must have a negative pregnancy test at screening

Who may not be able to

  • An acute flare-up (sudden worsening) of IPF within 6 months before screening or during screening
  • An FEV1/FVC ratio (a breathing test result) below 0.7 at screening, which can suggest a different lung condition
  • Needing oxygen all the time; part-time oxygen use, for example during exercise or sleep, is allowed
  • Expecting to have a lung transplant during the study
  • A current bacterial infection or antibiotics for a suspected lung infection in the 30 days before screening
  • Planned surgery during the study
  • Significant pulmonary hypertension (high blood pressure in the lungs)
  • Taking immunosuppressive medicines (other than corticosteroids), unless stopped at least 90 days or 5 half-lives before screening, whichever is longer
  • Taking corticosteroid tablets (such as prednisone) above 10 mg once a day within 30 days of screening
  • Currently smoking or vaping
  • Current cancer, a history of cancer, or a lymphoma-type condition within 2 years of screening, apart from some non-melanoma skin cancers
  • Current infection with hepatitis B, hepatitis C, or HIV
  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • History of severe depression, psychosis, or suicidal thoughts within 2 years of screening, as judged by the study doctor
  • Liver blood tests (AST or ALT) more than twice the normal limit at screening
  • Lung scarring from any cause other than IPF, significant heart disease, or another active medical problem that could affect taking part
  • Allergy to MTX-463 or its ingredients, or a past allergic reaction to a monoclonal antibody medicine
  • Previous use of MTX-463 or any other treatment targeting WISP1
  • Taking part in another clinical study or using another experimental treatment, unless stopped at least 30 days or 5 half-lives before screening, whichever is longer
  • Any other significant illness or abnormal test result at screening that could affect safety or the ability to complete the study

What taking part involves

  • • Taking the study medicine MTX-463
  • • Attending study visits and completing the tests and procedures set out in the study plan
  • • Using highly effective contraception if you or your partner could have children, during treatment and for up to 125 days after the last dose

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
164
Started
2025-05-05
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for idiopathic pulmonary fibrosis
  • • Phase2 - 164 participants
  • • A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with idiopathic pulmonary fibrosis

Where?

  • • Birmingham - WISPer Site in Birmingham, UK
  • • Cambridge - WISPer Site in Cambridge, UK
  • • Edinburgh - WISPer Site in Edinburgh, UK
  • • Oxford - WISPer Site in Oxford, UK

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

More detail

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.

Idiopathic Pulmonary Fibrosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ occurred ≥ 30 days
  • ✓ study visits and procedures
  • ✓ a negative serum pregnancy test at Screening

What the study is looking for

  • ✓Participants with IPF of any gender ≥ 40 years of age at time of signing the agreement to take part.
  • ✓Able to understand the study and provide signed, written agreement to take part.
  • ✓Able to read and understand the language of the agreement to take part and other study-related materials.
  • ✓FVC of ≥ 45 percent predicted (pp) at screening.
  • ✓DLCO of ≥ 25pp at screening.

Who cannot take part

  • ✗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...
  • ✗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.
See the full criteria
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.

Where Is This Study? (4 UK sites)

WISPer Site in Birmingham, UK

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)

WISPer Site in Cambridge, UK

Cambridge CB2 0BB, United Kingdom

Recruiting
Site contact (verified)

WISPer Site in Edinburgh, UK

Edinburgh EH16 4SA, United Kingdom

Recruiting
Site contact (verified)

WISPer Site in Oxford, UK

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Jeffrey Bornstein, MD

Sponsor contact

CONTACT

(617) 936-0960 Jeffrey@mediartx.com

Katherine Palu

Sponsor contact

CONTACT

(617) 936-0960
Data sourced from ClinicalTrials.gov · Last verified: 2026-06