About this trial
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 criteria
Qualifiers
Understanding and voluntarily signing the Informed Consent Form (ICF) for this study;
Age 18-75 years (inclusive), male or female;
Diagnosed as BD based on the ICBD-2013;
at least 2 oral ulcers present at V2 (the day of randomization) when V2 occurs 14-56 days after V1; OR
Disqualifiers
Active lesions associated with BD in major organs requiring immunosuppressive treatment, e.g., those in lungs (e.g., pulmonary aneurysm), blood vessels (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal tract (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis); Note: Patients with refractory BD who experienced gastrointestinal perforation, active bleeding, or obstruction, etc. within 3 months prior to randomization are to be excluded.
Any clinically significant heart disease (including but not limited to: unstable ischemic heart disease, NYHA III/IV left ventricular failure, or myocardial infarction) or clinically significant 12-lead ECG abnormalities detected during the 6 months prior to screening, which, at the investigator's discretion, may put the subject at safety risk or may interfere with the study assessments;
Colchicine within 7 days prior to randomization;
Perazathioprine, mycophenolate, baritinib, or tofacitinib within 10 days prior to randomization;
Trial design
Treatments tested in this trial
- Hemay005
- Hemay005
- Placebo