Actively Recruiting
EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Led by Mediar Therapeutics · Updated on 2026-04-16
85
Participants Needed
5
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diffuse cutaneous systemic sclerosis according to 2013 ACR/EULAR criteria
- Within 2 years of first non-Raynaud's symptom with mRSS >7; OR >2 to ≤5 years with mRSS 10-30 and negative RNA polymerase 3 autoantibody and no prior spontaneous skin improvement; OR >5 to ≤10 years with mRSS >15 to ≤25 and negative RNA polymerase 3 autoantibody and no prior spontaneous skin improvement
- At least 18 years old at signing informed consent
- Able to understand and sign informed consent form
- Able to read and understand the language of study materials
- Forced vital capacity (FVCpp) of at least 45 percent predicted
- Diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 30 percent predicted at screening
- Willing and able to complete all study visits and procedures
- Negative serum pregnancy test if of childbearing potential
- Agree to use highly effective contraception during treatment and for 5 half-lives or 125 days after last dose, whichever is longer
You will not qualify if you...
- Having another serious medical illness that may interfere with study completion
- Current use of immunosuppressive therapy, systemic glucocorticoids over 10 mg/day prednisone equivalent, or certain antifibrotic agents within specified timeframes prior to screening
- Previous or planned hematopoietic stem cell or solid organ transplant
- Previous treatment with CAR-T/CAR-NK therapy
- Clinically significant pulmonary arterial hypertension (PAH) or current PAH medications (except calcium channel blockers and phosphodiesterase-5 inhibitors)
- Pregnant or breastfeeding
- Elevated liver enzymes (AST or ALT >2 times upper limit of normal)
- Creatinine clearance below 45 mL/min
- History of myocardial infarction, angina, or congestive heart failure
- Abnormal coagulation tests (INR >2 or PTT >1.5 times upper limit of normal)
- Active infection with HIV, hepatitis B, or hepatitis C
- Recent clinically significant thrombotic event within 12 months
- Positive anticentromere antibody
- Systemic sclerosis renal crisis within 12 months
- Diagnosis of overlap syndromes or related autoimmune diseases
- Known or recent malignancy within 5 years except certain skin and cervical cancers
- Major surgery within 8 weeks prior or planned during study
- Unable to routinely access veins for blood draws and IV infusions
- Currently receiving another experimental agent or participating in another clinical trial with recent dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
EncompaSSc site in Newport Beach, CA 92663
Newport Beach, California, United States, 92663
Actively Recruiting
2
EncompaSSc site in Clearwater, FL 33765
Clearwater, Florida, United States, 33765
Actively Recruiting
3
EncompaSSc site in Tampa, FL
Tampa, Florida, United States, 33606
Actively Recruiting
4
EncompaSSc site in Baltimore, MD
Baltimore, Maryland, United States, 21224
Actively Recruiting
5
EncompaSSc site in Boston, MA
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
J
Jeffrey Bornstein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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