NCT06203457

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod study (ARGX-113-2106).

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod	Patients receiving efgartigimod infusions

Timeline

• Start date: 2023-11-29
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2024-01-12
• Last updated: 2026-02-20
• Results posted: 2026-02-20

Locations

11 sites across 3 countries: Belgium, Hungary, Poland