drugset / Trial / NCT06684847

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

NCT06684847

Phase 3 Active not recruiting 631 enrolled argenx
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-01-15
Primary completion
2027-07
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic Subcutaneous

Indications