drugset / Trial / NCT06684847
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | — | Subcutaneous |