ARGENX SE

UNITY Study Design

****UNITY is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension, designed to evaluate the efficacy, safety and tolerability of efgartigimod SC in adults with moderate-to-severe Sjögren's disease. To be eligible, patients had to meet the 2016 ACR/EULAR classification criteria for primary Sjögren's disease, test positive for anti-Ro/SSA autoantibodies and have moderate-to-severe systemic disease activity (clinESSDAI ≥6) while receiving stable background standard of care. Patients were randomized 1:1 to receive weekly efgartigimod SC or placebo during the double-blind treatment period. The primary endpoint was change from baseline in systemic disease activity, as measured by the clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI), at Week 48. Key secondary endpoints included the proportion of patients achieving low disease activity (clinESSDAI <5), responder status on the Sjögren's Tool for Assessing Response (STAR), change in patient-reported symptoms as measured by the Diary of Sjögren's Symptoms Assessment (DiSSA), and safety and tolerability.