New drug trial hopes to thicken skin Disease's fate

NCT ID NCT07287670

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

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study tests an experimental drug called MTX-474 in 85 people with diffuse cutaneous systemic sclerosis, a condition that causes skin thickening and organ damage. Participants will receive either MTX-474 or a placebo for 24 weeks to see if the drug safely reduces skin thickness and improves disease-related gene activity. The goal is to control the disease, not cure it.

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 85 people

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

Started

Apr 2026

Expected to finish

Dec 2028

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

18 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: 1. Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2. Participant is either: 1. Within 2 years of their first non-Raynaud's symptom and their mRSS is \>7; OR 2. \>2 and ≤5 years from their first non-Raynaud's symptom, their mRSS is between 10 and 30, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS on exams performed by the same clinician, or (2) they were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done; OR 3. \>5 and ≤10 years from their first non-Raynaud's symptom, their mRSS is between \>15 and ≤25, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS, or (2) were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done. 3. Participant is ≥18 years of age at time of signing the ICF. 4. Able to understand the study and provide a signed, written ICF 5. Able to read and understand the language of the ICF and other study-related materials 6. Forced vital capacity (FVCpp) of ≥45 pp10 7. Have diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥30 percent predicted at Screening 8. Willing and able to complete all protocol-required study visits and procedures 9. Participants of childbearing potential must have a negative serum pregnancy test at Screening. 10. All 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, whichever is longer Exclusion Criteria: 1. Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to complete the study 2. Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows: 1. Immunosuppresive agents: Cyclophosphamide (IV or oral if used in the 6 months prior to Screening), calcineurin inhibitors (if used in the 30 days prior to Screening), azathioprine (if used in the 30 days prior to Screening), Janus-kinase inhibitors (if used in the 30 days prior to Screening), rituximab (if used in the 6 months prior to Screening), tocilizumab (if used in the 60 days prior to Screening) or any other biologic Disease-Modifying Antirheumatic Drugs (DMARD, if used in the last 30 days or 3 half-lives prior to Screening, whichever is longer) 2. Antifibrotic agents: nintedanib or pirfenidone (if used in the 30 days prior to Screening). Also, exclusionary if used within 3 months of Screening are tyrosine-kinase inhibitors with recognized anti-fibrotic activity (imatinib, nilotinib, etc.) 3. Systemic glucocorticoids: equivalent doses of prednisone greater than 10 mg/day (≤10 mg/day allowed). Has received any pulse intramuscular (IM) or intravenous (IV) steroid within 1 month of Screening 4. Other agents: i. mycophenolate mofetil unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; ii. mycophenolic acid unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; iii. hydroxychloroquine unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study; and iv. methotrexate unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study. 3. Previous or planned hematopoietic stem cell or solid organ transplantation 4. Previous treatment with chimeric antigen receptor (CAR)-T/CAR-NK therapy 5. Clinically significant PAH as determined by the Investigator at, or prior to first day of dosing (Baseline) 6. Current use of PAH medication (endothelin receptor antagonists, prostacyclin analogues, soluble guanylate cyclase stimulators) excluding calcium channel blockers and phosphodiesterase-5 inhibitors 7. Pregnant or currently breastfeeding 8. Aspartate transaminase (AST) or alanine transaminase (ALT) \>2.0 upper limit of normal 9. Creatinine clearance \<45mL/min 10. History of myocardial infarction, angina or congestive heart failure 11. International normalized ratio \>2 or partial thromboplastin time \>1.5 × upper limit of normal 12. Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 13. History of clinically significant thrombotic event within 12 months prior to Screening 14. Positive anticentromere antibody 15. Systemic sclerosis renal crisis within 12 months prior to Screening 16. Confirmed diagnosis of overlap syndrome, systemic lupus erythematosus with anti-double strand (ds)DNA antibody, rheumatoid arthritis with anti-cyclic citrullinated peptide (anti-CCP) antibody, or systemic sclerosis mimics (eosinophilic fasciitis, scleromyxedema) at the time of inclusion in the study 17. Known malignancy or history of malignancy within 5 years of Screening other than non-melanoma skin cancer and in situ cervical cancer 18. Major surgery within 8 weeks prior to Screening or planned surgery during study period 19. Unable to routinely access veins for blood draws and IV infusions 20. Currently receiving another experimental agent or participating in another clinical trial. If a participant has recently received another experimental agent, then the last dose must have been at least 5 half-lives or 30 days (whichever is longer) prior to Screening 21. History of myocardial infarction, angina or congestive heart failure

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma

As listed by the trial registrant

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

Diffuse cutaneous systemic sclerosis

How to take part

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

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

58 sites in 10 countries. The list below names each one and where it is.
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 ↗
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

Show contact details

Locations

Aotearoa Clinical Trials
RECRUITING

Auckland, 2025, New Zealand

Contact Email: •••••@•••••
Austin Health
RECRUITING

Heidelberg, Victoria, 3084, Australia
Baylor Scott & White Research Institute
RECRUITING

Dallas, Texas, 75246, United States
Boston Medical Center
RECRUITING

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Clinical Research of West Florida
RECRUITING

Clearwater, Florida, 33765, United States
Clinical Research of West Florida
RECRUITING

Tampa, Florida, 33606, United States
EncompaSSc site in Ancona, Italy
NOT_YET_RECRUITING

Ancona, 60126, Italy
EncompaSSc site in Barcelona, Spain
NOT_YET_RECRUITING

Barcelona, 08003, Spain
EncompaSSc site in Barcelona, Spain
NOT_YET_RECRUITING

Barcelona, 08025, Spain
EncompaSSc site in Brasov, Romania
NOT_YET_RECRUITING

Brasov, 500283, Romania
EncompaSSc site in Bucharest, Romania
NOT_YET_RECRUITING

Bucharest, 030463, Romania
EncompaSSc site in Bucharest, Romania
NOT_YET_RECRUITING

Bucharest, 041303, Romania
EncompaSSc site in Bydgoszcz, Poland
NOT_YET_RECRUITING

Bydgoszcz, 85-168, Poland
EncompaSSc site in Catania, Italy
NOT_YET_RECRUITING

Catania, 95123, Italy
EncompaSSc site in Cleveland, OH
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
EncompaSSc site in Córdoba, Spain
NOT_YET_RECRUITING

Córdoba, 14004, Spain
EncompaSSc site in Genoa, Italy
NOT_YET_RECRUITING

Genoa, 16132, Italy
EncompaSSc site in Groningen, Netherlands
NOT_YET_RECRUITING

Groningen, 9713 GZ, Netherlands
EncompaSSc site in Houston, TX
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
EncompaSSc site in Kansas City, KS
NOT_YET_RECRUITING

Kansas City, Kansas, 66103, United States
EncompaSSc site in La Jolla, CA
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
EncompaSSc site in La Tronche, France
NOT_YET_RECRUITING

La Tronche, 38700, France
EncompaSSc site in Liverpool, UK
NOT_YET_RECRUITING

Liverpool, L7 8XP, United Kingdom
EncompaSSc site in Loma Linda, CA
NOT_YET_RECRUITING

Loma Linda, California, 92350, United States
EncompaSSc site in London, UK
NOT_YET_RECRUITING

London, SW8 3RN, United Kingdom
EncompaSSc site in Malaga, Spain
NOT_YET_RECRUITING

Málaga, 29004, Spain
EncompaSSc site in Milan, Italy
NOT_YET_RECRUITING

Milan, 20122, Italy
EncompaSSc site in Minneapolis, MN
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55455, United States
EncompaSSc site in Modena, Italy
NOT_YET_RECRUITING

Modena, 41124, Italy
EncompaSSc site in Montpellier, France
NOT_YET_RECRUITING

Montpellier, 34090, France
EncompaSSc site in Nowa Sól, Poland
NOT_YET_RECRUITING

Nowa Sól, 67-100, Poland
EncompaSSc site in Palo Alto, CA
NOT_YET_RECRUITING

Palo Alto, California, 94304, United States
EncompaSSc site in Paris, France
NOT_YET_RECRUITING

Paris, 75014, France
EncompaSSc site in Philadelphia, PA
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
EncompaSSc site in Phoenix, AZ
NOT_YET_RECRUITING

Phoenix, Arizona, 85054, United States
EncompaSSc site in Pittsburgh, PA
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15219, United States
EncompaSSc site in Roma, Italy
NOT_YET_RECRUITING

Roma, 00128, Italy
EncompaSSc site in Strasbourg, France
NOT_YET_RECRUITING

Strasbourg, 67000, France
EncompaSSc site in Timişoara, Romania
NOT_YET_RECRUITING

Timișoara, 300133, Romania
EncompaSSc site in Toulouse, France
NOT_YET_RECRUITING

Toulouse, 31059, France
EncompaSSc site in Valencia, Spain
NOT_YET_RECRUITING

Valencia, 46026, Spain
EncompaSSc site in Vandœuvre-lès-Nancy, France
NOT_YET_RECRUITING

Vandœuvre-lès-Nancy, 54500, France
EncompaSSc site in Walsgrave Coventry, UK
NOT_YET_RECRUITING

Coventry, CV2 2DX, United Kingdom
EncompaSSc site in Warszawa, Poland
NOT_YET_RECRUITING

Warsaw, 00-874, Poland
EncompaSSc site in Warszawa, Poland
NOT_YET_RECRUITING

Warsaw, 02-507, Poland
EncompaSSc site in Westcliff-on-Sea, UK
NOT_YET_RECRUITING

Westcliff-on-Sea, SS0 0RY, United Kingdom
EncompaSSc site in Woolloongabba, Australia
NOT_YET_RECRUITING

Woolloongabba, Queensland, 4102, Australia
Griffith University (Clinical Trial Unit)
RECRUITING

Southport, Queensland, 4222, Australia
Johns Hopkins University
RECRUITING

Baltimore, Maryland, 21205, United States
NYU Langone Health
RECRUITING

Brooklyn, New York, 11201, United States
NewportNativeMD, Inc.
RECRUITING

Newport Beach, California, 92663, United States
Sarasota Arthritis Center
RECRUITING

Sarasota, Florida, 34239, United States
Stryde Research - DFW
RECRUITING

Allen, Texas, 75013, United States

Contact Email: •••••@•••••
The University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of California Los Angeles Scleroderma Center
RECRUITING

Los Angeles, California, 90095, United States
University of Colorado Center for Lungs/Breathing/Scleroderma Clinic
RECRUITING

Aurora, Colorado, 80045, United States
Waikato Hospital
RECRUITING

Hamilton, 3204, New Zealand

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