argenx discontinues Phase 3 UNITY trial of efgartigimod SC in Sjögren's disease

Decision

An Independent Data Monitoring Committee recommended discontinuing the Phase 3 UNITY study of subcutaneous efgartigimod in adults with moderate‑to‑severe Sjögren's disease after an interim analysis determined the study could not meet its primary endpoint.

Safety

Safety during the study was reported as consistent with efgartigimod’s established profile and no new safety signals were identified.

UNITY study design and endpoints

UNITY was a Phase 3, randomized, double‑blind, placebo‑controlled, multicenter study with an open‑label extension. Eligible patients met the 2016 ACR/EULAR criteria for primary Sjögren's disease, were anti‑Ro/SSA positive and had moderate‑to‑severe systemic disease activity (clinESSDAI ≥6) while on stable standard of care. Patients were randomized 1:1 to receive weekly efgartigimod SC or placebo. The primary endpoint was change from baseline in systemic disease activity measured by clinESSDAI at Week 48. Key secondary endpoints included proportion achieving low disease activity (clinESSDAI <5), responder status on the Sjögren's Tool for Assessing Response (STAR), change in patient‑reported symptoms via the Diary of Sjögren's Symptoms Assessment (DiSSA), and safety and tolerability.

Next steps

Following study close and database lock, argenx will perform a comprehensive analysis of the data to understand the outcome and derive insights to inform future Sjögren's research.