drugset / Trial / NCT05823675
Safety and Clinical Activity of Itolizumab in aGVHD
RandomizedSequentialOpen-labelTreatment
Summary
To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with Newly diagnosed Acute Graft Versus Host Disease(aGVHD).
Timeline
- Start
- 2023-05-19
- Primary completion
- 2024-10
- Completion
- 2025-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itolizumab | Monoclonal antibody | 25 mg | Intravenous |
| Subject | Itolizumab | Monoclonal antibody | 50 mg | Intravenous |
| Subject | Itolizumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Itolizumab | Monoclonal antibody | 150 mg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | — | — |