drugset / Trial / NCT05486104
Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a multicenter, randomized, double-blind study. There are three dosage groups: Hemay005 45 mg BID group, 60 mg BID group or placebo group, with 36 patients in each dosage group. All patients will enter a 12-week double-blind treatment period. All subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.
Timeline
- Start
- 2022-11-08
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MUFEMILAST | Small molecule | 45 mg | Oral |
| Subject | MUFEMILAST | Small molecule | 60 mg | Oral |