Testing the Safety and Effectiveness of Itacitinib in Adults with Systemic Sclerosis in a Phase 2 Clinical Trial

What this Trial Is About

Systemic sclerosis SSc is a rare autoimmune disease that causes skin thickening and can affect internal organs, leading to serious health issues. This research evaluates the safety and effectiveness of itacitinib, a drug targeting specific pathways involved in SSc, particularly the JAK-STAT pathway linked to fibrosis and inflammation. The study focuses on adults with diffuse SSc, a severe form with significant skin and organ involvement. Participants are randomly assigned to receive either 200 mg of oral itacitinib daily or a matching placebo for 360 days. The study is a phase II, randomized, controlled trial with quadruple masking to compare outcomes between these two groups. The trial assesses treatment effects on skin thickening and disease activity over the course of one year. During the study, participants undergo regular assessments including skin scoring modified Rodnan skin score, disease activity evaluations, and quality of life questionnaires at multiple time points up to 360 days. Safety is monitored through adverse event tracking and laboratory tests. The main outcome measured is the change in skin thickness after 360 days of treatment, helping researchers understand the potential impact of itacitinib on systemic sclerosis.

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis