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A Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MTX-474 in the Treatment of Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Led by Mediar Therapeutics · Updated on 2026-06-04
85
Participants Needed
6
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
The trial investigates diffuse cutaneous systemic sclerosis (dcSSc), a condition characterized by skin thickening and fibrosis. This Phase 2, randomized, double-blind, placebo-controlled study evaluates the safety and effects of a monoclonal antibody called MTX-474 in people with dcSSc. Researchers aim to study changes in skin thickness and other measures to better understand the treatment's impact on this condition. Participants will be randomly assigned in a 3:2 ratio to receive either MTX-474 or a placebo through intravenous infusions every 4 weeks, starting at Day 0 and ending at Week 20. Use of certain approved therapies for dcSSc is allowed under specific conditions. The study includes treatment visits up to Week 24, followed by a safety follow-up visit at Week 28, eight weeks after the last infusion. During the trial, participants will undergo regular assessments including Modified Rodnan Skin Score (mRSS) evaluations at screening, baseline, and treatment visits, spirometry and lung imaging at screening and select weeks, and skin biopsies at baseline and Week 12. Blood samples will be collected periodically for safety checks, antibody level measurements, and pharmacokinetic analyses. The primary outcome is the change in skin thickness from baseline to Week 24, with safety and tolerability monitored throughout the study.
CONDITIONS
Brief 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 between >2 and 64 years from first non-Raynaud's symptom with mRSS 10-30 and negative RNA polymerase 3 autoantibody without prior spontaneous skin improvement; OR between >5 and 6410 years from first non-Raynaud's symptom with mRSS >15 to 64 and negative RNA polymerase 3 autoantibody without prior spontaneous skin improvement
- Age 18 years or older at time of consent
- Able to understand and sign informed consent
- Able to read and understand the study materials language
- Forced vital capacity (FVC) 64 45% predicted
- Diffusing capacity of the lungs for carbon monoxide (DLCO) 64 30% predicted at screening
- Willing and able to complete all study visits and procedures
- Negative serum pregnancy test at screening for participants of childbearing potential
- Agree to use medically approved contraception during treatment and for 5 half-lives or 125 days after last dose
You will not qualify if you...
- Having another serious medical illness that would interfere with study completion
- Current use of immunosuppressive therapy or systemic glucocorticoids above 10 mg/day prednisone equivalent
- Use of specific immunosuppressive agents or antifibrotic drugs within defined timeframes prior to screening
- Previous or planned stem cell or organ transplantation
- Previous treatment with CAR-T/CAR-NK therapy
- Clinically significant pulmonary arterial hypertension
- Current use of pulmonary arterial hypertension medications excluding certain drugs
- Pregnant or breastfeeding
- Elevated liver enzymes (AST or ALT >2 times upper limit of normal)
- Creatinine clearance <45 mL/min
- History of heart conditions including myocardial infarction, angina, or heart failure
- Abnormal blood clotting test results
- Active infection with HIV, hepatitis B, or hepatitis C
- Recent significant thrombotic event
- Positive anticentromere antibody
- Recent systemic sclerosis renal crisis
- Diagnosis of overlap syndrome or related autoimmune conditions
- Current or recent malignancy except certain skin or cervical cancers
- Recent or planned major surgery
- Inability to access veins routinely for blood draws or infusions
- Current participation in another clinical trial or recent use of experimental agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive MTX-474 or placebo by intravenous infusion every 4 weeks, beginning at Day 0 and ending at Week 20. Various assessments including mRSS, spirometry, HRCT, DLCO, skin biopsies, and blood draws are conducted throughout treatment.
6 visits (in-person) every 4 weeks
Duration - 4 weeks
Participants attend a Safety Follow-Up Visit 8 weeks after the final infusion to monitor safety and collect additional blood samples.
1 visit (in-person) at Week 28
Trial Site Locations
Total: 6 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
6
EncompaSSc site in Dallas, TX
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
J
Jeffrey Bornstein, MD
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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