Phase 2 Study of MTX-474 to Assess Safety and Effectiveness in Adults with Diffuse Cutaneous Systemic Sclerosis

What this Trial Is About

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of MTX-474 in adults with diffuse cutaneous systemic sclerosis dcSSc. This condition involves skin thickening and other complications, and the study seeks to measure changes in skin severity as well as other health markers. The trial allows certain approved therapies alongside the study drug under specific conditions. Participants will be randomly assigned in a 32 ratio to receive either MTX-474 or a matching placebo through intravenous infusions every 4 weeks from Day 0 to Week 20. The treatment phase concludes with an End of Treatment Visit at Week 24, followed by a Safety Follow-Up Visit at Week 28, eight weeks after the last infusion. Both groups may continue some approved dcSSc therapies as allowed by the study criteria. Throughout the study, participants will undergo multiple assessments, including skin thickness evaluations, lung function tests, high-resolution CT scans, skin biopsies, and blood draws. These tests will occur from screening through Week 28 to monitor safety, drug levels, and disease markers. The main outcome measured is the change in Modified Rodnan Skin Score from baseline to Week 24, with additional safety and biological measures collected during the study period.

EncompaSSc: Evaluation of MTX-474 in Participants With Diffuse Cutaneous Systemic Sclerosis (dcSSc)