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.
this study is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study to evaluate Hemay005 efficacy and safety of the treatment of patients with Behçet Disease(BD). Around 252 subjects will be randomized into this study. The whole study will including 4 phases that a screening phase, core-treatment phase(12weeks), extended-treatment phase (12weeks) and follow-up phase(4 weeks). Screening: All subjects will undergo a screening period of up to 6 weeks prior to baseline visit (visit 2, day of randomization, Day0). Core treatment phase: eligible BD patients will randomly assigned to Hemay005 high-dose group, Hemay005 low-dose group, placebo (core treatment phase) + Hemay005 high-dose group (extended treatment phase), or placebo (core treatment phase) + Hemay005 low-dose group (extended treatment phase). During the core-treatment period, hemay005 will be administered twice daily for 12 weeks. The randomization was stratified to minimize the imbalance between treatment groups. Extended treatment phase: Subjects in the high-dose and low-dose groups during the extended treatment period will still given the dose of core-treatment phase for 12 weeks. Subjects who received placebo during the core treatment will assigned to either a high-dose group or a low-dose group according the allocation at visit 2 until 12 weeks after. During this period, the subject and investigator are remain blind at this stage. Follow up phase: Subjects in the study (also including those who withdraw from treatment for any reason) will have another follow up for 4 weeks after the end of the last administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
89
to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease.
Area under the curve (AUC) for the number of oral ulcers from baseline through Week 12
Time frame: week 12
Proportion of subjects achieving an oral ulcer complete response
Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) by Week 6 after dosing, and who remain oral ulcer free for at least 6 additional weeks during the Treatment Phase
Time frame: week 6
Complete response rate for oral ulcers
Complete response rate for oral ulcers at day 3, day 7 and Week 12
Time frame: day 3, day 7 and week12
change of the pain evaluation of oral ulcers as measured by Visual analogue scale(VAS)(From 0-100, the higher score means the worse outcome)
Change from baseline in the pain of oral ulcers as measured by VAS at Week 12
Time frame: week12
change of the number of oral ulcers
Change from baseline in the number of oral ulcers at Week 12
Time frame: week12
Time to oral ulcer resolution
Time to oral ulcer resolution (complete response) that the first instance when a subject has a complete response during the core-Treatment Phase
Time frame: week12
Proportion of subjects achieving an oral ulcer complete response in the core-treatment phase
Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) and who remain oral ulcer free during the core-treatment Phase
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui provincial hospital
Hefei, Anhui, China
Beijing hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, China
...and 21 more locations
Time frame: week12
Number of oral ulcers who has a reappearance during the core-treatment phase
Number of oral ulcers following loss of complete response that the first instance when a subject has a reappearance of oral ulcers following a complete response during the core-Treatment Phase
Time frame: week12
Time to oral ulcer reappearance during the core-treatment
Time to recurrence of oral ulcers following loss of complete response that the first instance when a subject has a reappearance of oral ulcers following a complete response during the core-Treatment Phase
Time frame: week12
change of the total score of Physician's Global Assessment(PGA)
change from baseline in the total score of the PGA of skin lesions of BD at week 12 in those subjects who had at baseline
Time frame: week12
change of BD Current Activity Form(BDCAF)
change from baseline in the total score of the BDCAF questionnaire at week 12
Time frame: week12
change of Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
change from baseline in the total score of the MDHAQ questionnaire at week 12
Time frame: week12
change of short from health survey(SF-36)
change from baseline in the total score of the SF-36 questionnaire at week 12
Time frame: week12
Complete response rate for genital ulcers
Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline
Time frame: week12
change of the pain evaluation of genital ulcers
Change from baseline in the pain of genital ulcers as measured by VAS at Week 12
Time frame: week12
Change of the Behçet's syndrome activity score(BSAS) score
Change from Baseline in BSAS score at Week 12
Time frame: week12
Maximum Plasma Concentration (Cmax)
the population pharmacokinetic (popPK) characteristics Cmax of Hemay005 in BD patients
Time frame: week24
Minimum Plasma Concentration (Cmin)
the population pharmacokinetic (popPK) characteristics Cmin of Hemay005 in BD patients
Time frame: week24
Time to peak (Tmax)
the population pharmacokinetic (popPK) characteristics Tmax of Hemay005 in BD patients
Time frame: week24
Elimination half-life (T1/2)
the population pharmacokinetic (popPK) characteristics T1/2 of Hemay005 in BD patients
Time frame: week24
Area under drug time curve (AUC)
the population pharmacokinetic (popPK) characteristics AUC of Hemay005 in BD patients
Time frame: week24
Clearance (Cl)
the population pharmacokinetic (popPK) characteristics Cl of Hemay005 in BD patients
Time frame: week24
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
the Incidence of Treatment-Emergent Adverse Events of Hemay005 in BD patients with different dosing group
Time frame: week24
the number of subjects who terminated hemay005 prematurely due to adverse events (AE) [Safety and Tolerability])
the number of subjects who terminated hemay005 prematurely due to adverse events (AE) in BD patients with different dosing group
Time frame: week24