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Safety and Efficacy of MTX-474 in Adults with Diffuse Cutaneous Systemic Sclerosis (dcSSc) – A Phase 2 Randomized, Double‑Blind, Placebo‑Controlled Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Diffuse Cutaneous Systemic Sclerosis is a rare disease that causes the skin on large areas of the body to become thick and tight, and it can also affect internal organs. The trial is testing a new medicine called MTX-474, which is given by IV infusion, and it is being compared with a harmless fluid that looks the same (placebo).

The purpose of the study is to find out if the medicine can reduce skin thickening. Participants will receive the assigned treatment every few weeks for about six months, with regular visits to check safety and to measure skin changes using the modified Rodnan skin score, a simple scale doctors use to rate how tight the skin feels. Small blood samples and occasional skin samples may be taken to look for any reactions, and any side effects will be recorded throughout the study.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment and consent

    After joining the study, the patient signs an informed consent form that explains the purpose, procedures, risks, and benefits of the trial.

    The consent process is documented before any study procedures are performed.

  2. Step 2

    Baseline assessments

    The patient undergoes a physical examination, vital‑sign measurement, and collection of blood samples for laboratory tests.

    Skin thickness is measured using the modified roddan skin score (mrss), which provides a numeric value for skin involvement.

    A skin biopsy may be taken to evaluate tissue characteristics before treatment begins.

  3. Step 3

    Randomization to treatment group

    The patient is assigned by a computer system to receive either mtx-474 or a placebo solution.

    The study is double‑blind, meaning the patient and the clinical staff do not know which product is being administered.

  4. Step 4

    Iv infusion of study medication

    The assigned product is given by intravenous (iv) infusion, which means the medication is delivered directly into a vein.

    If the patient receives mtx-474, the dose is 4 mg per kilogram of body weight.

    The placebo consists of a dextrose solution or normal saline; it contains no active drug and is also administered by iv infusion.

    Infusions are performed at each scheduled study visit and continue for the duration of the trial, which includes assessments up to week 24.

  5. Step 5

    Regular safety monitoring visits

    At each visit, the patient’s vital signs, physical condition, and laboratory results are reviewed for any adverse events.

    The patient reports any new symptoms or side effects, which are recorded by the study team.

  6. Step 6

    Mid‑study assessment at week 12

    The patient returns for a week 12 visit, during which a second skin biopsy is performed to assess gene‑signature response.

    Blood samples are collected to evaluate pharmacokinetic (pk) parameters, which describe how the drug is processed in the body.

    Skin thickness is measured again using the mrss to track changes from baseline.

  7. Step 7

    Final assessment at week 24

    The patient attends a week 24 visit for the primary efficacy evaluation.

    Skin thickness is measured a third time with the mrss to determine the mean change from baseline.

    Comprehensive safety evaluations, including physical examination, vital signs, and laboratory tests, are completed.

    All study medication is stopped after the week 24 assessment.

  8. Step 8

    Study completion and data collection

    After the final visit, the patient’s data are finalized for analysis.

    The patient may be offered standard medical care outside the study, as determined by the treating physician.

Who can join the trial?

12 criteria

  • You have been diagnosed with diffuse cutaneous systemic sclerosis (a type of connective‑tissue disease) and your diagnosis meets the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria.
  • If you could become pregnant, you must agree to use a medically approved, highly effective method of contraception during the study and for at least 125 days after the last dose (or longer, based on the drug’s half‑life).
  • Your disease must fit into one of the following time frames and skin‑thickness scores:
    • Within 2 years of your first symptom that is not Raynaud’s, and a modified Rodnan skin score (mRSS) higher than 7.
    • Between more than 2 years and up to 5 years from your first non‑Raynaud’s symptom, an mRSS between 10 and 30, a negative test for the RNA polymerase 3 autoantibody, and you have never had a natural improvement in skin thickness of 4 points or more.
    • Between more than 5 years and up to 10 years from your first non‑Raynaud’s symptom, an mRSS greater than 15 but not more than 25, a negative test for the RNA polymerase 3 autoantibody, and you have never had a natural improvement in skin thickness of 4 points or more.
    • You must be at least 18 years old when you sign the study’s Informed Consent Form (ICF).
    • You must be able to understand the study information and sign the written ICF.
    • You must be able to read and understand the language used in the ICF and other study documents.
    • Your lung test called Forced Vital Capacity (FVC) must be at least 45 % of the predicted normal value.
    • Your lung test called Diffusing Capacity for Carbon Monoxide (DLCO) must be at least 30 % of the predicted normal value at the screening visit.
    • You must be willing and able to attend all required study visits and complete the study procedures.
    • If you could become pregnant, you must have a negative pregnancy test (blood test) before you start the study.

Who cannot join the trial?

23 criteria

  • Having another serious illness that, in the doctor’s view, would make it hard to finish the study.
  • Kidney function measured by creatinine clearance is less than 45 mL/min (a low level means the kidneys are not working well).
  • Blood clotting tests are abnormal: an International normalized ratio higher than 2 or a partial thromboplastin time more than 1.5 times the normal upper limit.
  • Current infection with HIV (human immunodeficiency virus), hepatitis B, or hepatitis C (viral infections that affect the immune system or liver).
  • Had a serious blood‑clot problem (a thrombotic event) within the past 12 months.
  • Test shows a positive anticentromere antibody (a blood marker linked to certain autoimmune diseases).
  • Experienced a systemic sclerosis renal crisis (sudden severe kidney problems related to the disease) within the past 12 months.
  • Has a diagnosed “overlap” condition such as systemic lupus erythematosus with anti‑double‑strand DNA antibodies, rheumatoid arthritis with anti‑CCP antibodies, or diseases that look like systemic sclerosis (e.g., eosinophilic fasciitis or scleromyxedema).
  • Has a known cancer or a history of cancer in the last 5 years, except for non‑melanoma skin cancer or early‑stage cervical cancer.
  • Had major surgery in the 8 weeks before screening or plans to have surgery during the study.
  • Cannot regularly have blood drawn or receive IV medicines because veins are difficult to access.
  • History of heart problems such as a heart attack (myocardial infarction), chest pain due to reduced blood flow (angina), or weakened heart function (congestive heart failure).
  • Currently taking another experimental drug or participating in another clinical trial, unless the last dose was at least 5 drug half‑lives or 30 days ago (whichever is longer).
  • Currently using certain immune‑suppressing or anti‑fibrotic medicines, including:
    • Immunosuppressants such as cyclophosphamide, calcineurin inhibitors, azathioprine, Janus‑kinase inhibitors, rituximab, tocilizumab, or other biologic DMARDs.
    • Anti‑fibrotic drugs like nintedanib, pirfenidone, or similar tyrosine‑kinase inhibitors (e.g., imatinib, nilotinib).
    • Systemic steroids (prednisone) higher than 10 mg per day or any high‑dose steroid injection in the last month.
    • Other medicines such as mycophenolate mofetil, mycophenolic acid, hydroxychloroquine, or methotrexate unless they have been at a stable dose for several months with no planned changes.
    • Has had, or is planning, a hematopoietic stem cell transplant or a solid organ transplant.
    • Has previously received chimeric antigen receptor T‑cell or NK‑cell therapy (CAR‑T/CAR‑NK).
    • Has clinically significant pulmonary arterial hypertension (PAH) as judged by the doctor before the first dose.
    • Is currently taking PAH medicines such as endothelin receptor antagonists, prostacyclin analogues, or soluble guanylate cyclase stimulators (calcium channel blockers and phosphodiesterase‑5 inhibitors are not included).
    • Is pregnant or currently breastfeeding.
    • Liver enzymes AST (aspartate transaminase) or ALT (alanine transaminase) are more than twice the normal upper limit.
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Investigated drugs

MTX-474 is an experimental medicine being given through an IV infusion. In this study it is the drug being tested to see if it can safely reduce skin thickening in people with diffuse cutaneous systemic sclerosis. Researchers will watch how the body reacts to the medicine and whether it improves the skin condition compared with not receiving the active drug.

What is already known about the treatment

  • MTX-474

    The drug is given as an intravenous (IV) infusion of a clear solution. It is currently an investigational medicine being studied in a Phase 2 clinical trial and has not yet received market approval. The trial is testing it for the treatment of diffuse cutaneous systemic sclerosis, a rare autoimmune skin disease. MTX-474 is thought to work by modulating the immune system to reduce abnormal skin thickening, and it is classified as an experimental immunomodulatory agent.

  • DEXTROSE/VIOSER 5% w/v Solution for Infusion

    This placebo is a sterile IV solution that contains 5 % glucose (dextrose) and is administered through an infusion line. It is an approved medical product that is routinely used to provide calories and fluid to patients. In the study it serves as a control fluid with no active drug effect. Dextrose works by supplying simple sugar for energy and is classified as a carbohydrate (IV) solution.

  • NaCl 0.9 % B. Braun, solution pour perfusion

    The placebo is a sterile IV infusion of normal saline, containing 0.9 % sodium chloride. It is a widely accepted and approved electrolyte solution used to replace fluids and maintain salt balance. In the trial it is used as a neutral control without therapeutic effect on the disease. The solution provides sodium and chloride ions to the bloodstream and is classified as an electrolyte (IV) solution.

Investigated diseases

Diffuse Cutaneous Systemic Sclerosis - Diffuse cutaneous systemic sclerosis is an autoimmune condition that leads to hardening and thickening of the skin. The skin changes often start on the hands, face, and forearms and then spread toward the trunk and upper arms. Over time the tightening can limit joint movement and cause the fingers to become less flexible. The disease may also involve small blood vessels, leading to changes in circulation. As the condition progresses, internal organs such as the lungs or digestive tract can become affected, reflecting the systemic nature of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523288-39-00Protocol codeMTX-474-S201Estimated enrolment78 patientsSponsorMediar Therapeutics Inc.

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