drugset / Trial / NCT06145893
A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
RandomizedParallel-groupTriple-blindPrevention
Summary
This is a phase 3, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with an equal randomization among the Hemay005 high dose, lower dose and placebo treatment groups. After subject randomization, each subject will enter an core-treatment Phase for 12 weeks following an extended-treatment phase for another 40 weeks and a follow up phase for 4weeks.
Timeline
- Start
- 2023-11-13
- Primary completion
- 2026-05-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MUFEMILAST | Small molecule | 45 mg | Oral |
| Subject | MUFEMILAST | Small molecule | 60 mg | Oral |