Sjögren’s Disease
Study Protocol
Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjögren’s Disease.
Study Duration
2 YEARS & 2 MONTHS
INCLUSION CRITERIA
- ≥18 years old (male or female)
- Physician-confirmed primary Sjögren’s disease per ACR/EULAR 2016 criteria
- ClinESSDAI ≥6
- Anti-Ro/SS-A positive at central laboratory
- Unstimulated salivary flow ≥0.01 mL/min