drugset / Trial / NCT06145893

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease

NCT06145893

Phase 3 Recruiting 162 enrolled Ganzhou Hemay Pharmaceutical Co., Ltd
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

EvaluationDrugModalityDoseRoute
Subject MUFEMILAST Small molecule 45 mg Oral
Subject MUFEMILAST Small molecule 60 mg Oral

Indications