NCT06684847

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

A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 631 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sjogrens Disease

Interventions

Type	Name	Description
BIOLOGICAL	Efgartigimod PH20 SC	subcutaneous efgartigimod PH20 SC given by prefilled syringe
OTHER	Placebo PH20 SC	subcutaneous placebo PH20 SC given by prefilled syringe

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2024-11-12
• Last updated: 2026-04-16

Locations

303 sites across 39 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Estonia, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Korea, Spain, Sweden, Tunisia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study