drugset / Trial / NCT06169722
TDI01 Suspension in the Treatment of Chronic Graft-versus-host Disease (cGVHD))
Non-randomizedSequentialOpen-labelTreatment
Summary
1. Phase Ib study stage: Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics 2. Phase II study stage: Primary objective: To evaluate the efficacy Secondary objectives: To evaluate the safety
Timeline
- Start
- 2024-02-06
- Primary completion
- 2026-02
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TDI01 | Unknown | 200 mg | Oral |
| Comparator | TDI01 | Unknown | 400 mg | Oral |