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A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease

NCT04609397 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2022-06-21

No results posted yet for this study

Summary

This is a phase 2, 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 12weeks and a follow up phase for 4weeks.

Conditions

  • Behçet Disease

Interventions

DRUG

Hemay005

Hemay005 tables 60mg bid p.o;

DRUG

Hemay005

Hemay005 tables 45mg bid p.o

OTHER

Placebo

placebo to Hemay005 tables bid p.o

Sponsors & Collaborators

  • Tianjin 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
2020-11-30
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • China

Study Locations

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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 NCT04609397 on ClinicalTrials.gov