RecruitingPhase 3NCT06145893

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

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


Sponsor

Ganzhou Hemay Pharmaceutical Co., Ltd

Enrollment

162 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hemay005, a drug called Hemay005, and others for people with behçet's disease. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHemay005

Hemay005 tables 60mg bid p.o;

DRUGHemay005

Hemay005 tables 45mg bid p.o;

DRUGPlacebo

placebo to Hemay005 tables bid p.o


Locations(22)

Beijing Friendship hospital capital medical hospital

Beijing, Beijing Municipality, China

Peking university first hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking university third hospital

Beijing, Beijing Municipality, China

Xuanwu hospital capital medical university

Beijing, Beijing Municipality, China

The first affiliated hospital of Xiamen University

Xiamen, Fujian, China

Guangdong second provincial central hospital

Guangzhou, Guangdong, China

Sun Yat-Sen memorial hospital

Guangzhou, Guangdong, China

The third affiliated hospital sun yat-sen university

Guangzhou, Guangdong, China

The university of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

Affiliated hospital of Guilin Medical university

Guilin, Guangxi, China

The second hospital of Hebei medical university

Shijiazhuang, Hebei, China

Xinxiang Central hospital

Xinxiang, Henan, China

The first affiliated hospital of Nanchang university

Nanchang, Jiangsu, China

The first affiliated hospital of Soochow university

Suzhou, Jiangsu, China

The affiliated hospital of Xuzhou medical university

Xuzhou, Jiangsu, China

Jilin Province People's hospital

Changchun, Jilin, China

Linyi People's Hospital

Linyi, Shandong, China

Tongji hospital of Tongji university

Shanghai, Shanghai Municipality, China

Second hospital of shanxi medical university

Taiyuan, Shanxi, China

The first affiliated hospital, Zhejiang University school of medicine

Hangzhou, Zhejiang, China

The first affiliated hospital of Wenzhou Medical university

Wenzhou, China

View Full Details on ClinicalTrials.gov

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NCT06145893


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