NCT07287670 EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
| NCT ID | NCT07287670 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mediar Therapeutics |
| Condition | Diffuse Cutaneous Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2026-05 |
| Primary Completion | 2028-12 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 clinica