MedTrace Logo

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

NCT06145893 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

  • Behçet's Disease

Interventions

DRUG

Hemay005

Hemay005 tables 60mg bid p.o;

DRUG

Hemay005

Hemay005 tables 45mg bid p.o;

DRUG

Placebo

placebo to Hemay005 tables bid p.o

Sponsors & Collaborators

  • Ganzhou Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhanguo Li, Doctor · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2026-05-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06145893 on ClinicalTrials.gov