MTX-474: Dosage level: 4 mg/kg Unit dose strength: 50mg/ml MTX-474 is a human immunoglobulin G1 (IgG1) monoclonal antibody that binds the human EphrinB2 with high specificity and high affinity. MTX-474 is being developed as a therapy for patients with systemic sclerosis (SSc).
Placebo: Placebo
Study summary
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-474 in Participants with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline in Modified Rodnan Skin Score (mRSS) — Baseline to week 24 Mean change from baseline to week 24 in the modified Rodnan Skin Score, a clinician-assessed measure of skin thickness across 17 body areas.
Unit of measure: Score (range 0-51)
Trial sites (58)
Facility
City
Region
Status
EncompaSSc site in Phoenix, AZ
Phoenix
Arizona
Not Yet Recruiting
EncompaSSc site in La Jolla, CA
La Jolla
California
Not Yet Recruiting
EncompaSSc site in Loma Linda, CA
Loma Linda
California
Not Yet Recruiting
University of California Los Angeles Scleroderma Center
Los Angeles
California
Recruiting
NewportNativeMD, Inc.
Newport Beach
California
Recruiting
EncompaSSc site in Palo Alto, CA
Palo Alto
California
Not Yet Recruiting
University of Colorado Center for Lungs/Breathing/Scleroderma Clinic
Aurora
Colorado
Recruiting
Clinical Research of West Florida
Clearwater
Florida
Recruiting
Sarasota Arthritis Center
Sarasota
Florida
Recruiting
Clinical Research of West Florida
Tampa
Florida
Recruiting
EncompaSSc site in Kansas City, KS
Kansas City
Kansas
Not Yet Recruiting
Johns Hopkins University
Baltimore
Maryland
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
Boston Medical Center
Boston
Massachusetts
Recruiting
EncompaSSc site in Minneapolis, MN
Minneapolis
Minnesota
Not Yet Recruiting
NYU Langone Health
Brooklyn
New York
Recruiting
EncompaSSc site in Cleveland, OH
Cleveland
Ohio
Not Yet Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma
Recruiting
EncompaSSc site in Philadelphia, PA
Philadelphia
Pennsylvania
Not Yet Recruiting
EncompaSSc site in Pittsburgh, PA
Pittsburgh
Pennsylvania
Not Yet Recruiting
Stryde Research - DFW
Allen
Texas
Recruiting
Baylor Scott & White Research Institute
Dallas
Texas
Recruiting
EncompaSSc site in Houston, TX
Houston
Texas
Not Yet Recruiting
Griffith University (Clinical Trial Unit)
Southport
Queensland
Recruiting
EncompaSSc site in Woolloongabba, Australia
Woolloongabba
Queensland
Not Yet Recruiting
Austin Health
Heidelberg
Victoria
Recruiting
EncompaSSc site in La Tronche, France
La Tronche
France
Not Yet Recruiting
EncompaSSc site in Montpellier, France
Montpellier
France
Not Yet Recruiting
EncompaSSc site in Paris, France
Paris
France
Not Yet Recruiting
EncompaSSc site in Strasbourg, France
Strasbourg
France
Not Yet Recruiting
EncompaSSc site in Toulouse, France
Toulouse
France
Not Yet Recruiting
EncompaSSc site in Vandœuvre-lès-Nancy, France
Vandœuvre-lès-Nancy
France
Not Yet Recruiting
EncompaSSc site in Ancona, Italy
Ancona
Italy
Not Yet Recruiting
EncompaSSc site in Catania, Italy
Catania
Italy
Not Yet Recruiting
EncompaSSc site in Genoa, Italy
Genoa
Italy
Not Yet Recruiting
EncompaSSc site in Milan, Italy
Milan
Italy
Not Yet Recruiting
EncompaSSc site in Modena, Italy
Modena
Italy
Not Yet Recruiting
EncompaSSc site in Roma, Italy
Roma
Italy
Not Yet Recruiting
EncompaSSc site in Groningen, Netherlands
Groningen
Netherlands
Not Yet Recruiting
Aotearoa Clinical Trials
Auckland
New Zealand
Recruiting
+ 18 more sites — see the full list on the official registry below.
More Mediar Therapeutics trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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