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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
WISPer Site in Birmingham, UK
Birmingham B15 2GW, United Kingdom
WISPer Site in Cambridge, UK
Cambridge CB2 0BB, United Kingdom
WISPer Site in Edinburgh, UK
Edinburgh EH16 4SA, United Kingdom
WISPer Site in Oxford, UK
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Jeffrey Bornstein, MD
Sponsor contactCONTACT
Katherine Palu
Sponsor contactCONTACT
