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)

NCT07287670 Phase 2 RECRUITING

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)

Details

Lead sponsor	Mediar Therapeutics
Phase	Phase 2
Status	RECRUITING
Enrolment	85
Start date	2026-05
Completion	2028-12

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

• MTX-474
• Placebo

Primary outcomes

• 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)

Countries

United States