drugset / Trial / NCT04541589
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
Non-randomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.
Timeline
- Start
- 2021-01-05
- Primary completion
- 2024-08-19
- Completion
- 2024-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | iscalimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | iscalimab | Monoclonal antibody | 600 mg | Subcutaneous |