drugset / Trial / NCT04810754
An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus
Phase 2
Unknown
10 enrolled
Charite University, Berlin, Germany
Charité Clinical Trial Office (CTO) · collabGerman Cancer Research Center · collabJanssen-Cilag G.m.b.H · collabLabor Berlin-Charité Vivantes G.m.b.H · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a monocenter, open-label Phase II trial for refractory SLE patients currently on stable background immunosuppressive therapy. Treatment in this trial will be daratumumab weekly for a period of 8 weeks. This study will enroll 10 patients.
Timeline
- Start
- 2021-06-30
- Primary completion
- 2023-03-31
- Completion
- 2023-12-31
Publications
- Background Ostendorf L, Burns M, Durek P, Heinz GA, Heinrich F, Garantziotis P, Enghard P, Richter U, Biesen R, Schneider U, Knebel F, Burmester G, Radbruch A, Mei HE, Mashreghi MF, Hiepe F, Alexander T. Targeting CD38 with Daratumumab in Refractory Systemic Lupus Erythematosus. N Engl J Med. 2020 Sep 17;383(12):1149-1155. doi: 10.1056/NEJMoa2023325.
- Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |