Clinical Trial

A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

Study acronym: Unity
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-17
Trial Details
NCT Number NCT06684847
Lead Sponsor argenx
Conditions Primary Sjogrens Disease
Enrollment 631 participants
Start Date 2025-01-15
Primary Completion 2027-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-16