A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
ConditionBehçet's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGanzhou Hemay Pharmaceutical Co., Ltd
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hemay005
DrugHemay005 tables 60mg bid p.o;
Hemay005
DrugHemay005 tables 45mg bid p.o;
Placebo
Drugplacebo to Hemay005 tables bid p.o
Treatment groups
162 Participants
are divided into 3 treatment groupsGroup A: Hemay005 high dose groupExperimental treatment 1 intervention
Group B: Hemay005 lower dose groupExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy assessed by oral ulcers
Area under the curve (AUC) of the number of oral ulcers in BD patients from baseline to Week 12
Time frame
week 12Secondary outcomes
1
efficacy assessed by oral ulcers
Complete response rate for oral ulcers at Week 12，22，32，42，52; A complete response is defined as the proportion of subjects who are oral ulcer free
Time frame
week 12, 22, 32, 42, 522
pain of oral ulcers assessed by VAS
Change from baseline in the pain of oral ulcers as measured by VAS at Week 12，22，32，42，52
Time frame
week 12, 22, 32, 42, 523
efficacy assessed by genital ulcers
Complete response rate for genital ulcers at Week 12，22，32，42，52 for subjects who had genital ulcers at Baseline; A complete response is defined as the proportion of subjects who are genital ulcer-free
Time frame
week 12, 22, 32, 42, 524
pain of genital ulcers assessed by VAS
Change from baseline in the pain of genital ulcers, as measured by VAS at Week 12，22，32，42，52 in subjects who had genital ulcers at baseline
Time frame
week 12, 22, 32, 42, 52Other outcomes
1
efficacy assessed by oral and genital ulcers
The AUC for the combined number of oral and genital ulcers from baseline through Week 12
Time frame
week 122
efficacy assessed by genital ulcers
Time to genital ulcer complete response, ie, the first instance when a subject has a complete response, during the Placebo-controlled Treatment Phase
Time frame
week 1, 2, 4, 6, 8, 10, 123
efficacy assessed by genital ulcers
Proportion of subjects with no genital ulcers following complete response, ie, the first time when a subject has a complete response, during the Placebo-controlled Treatment Phase
Time frame
week 1, 2, 4, 6, 8, 10, 124
efficacy assessed by genital ulcers
Number of genital ulcers following loss of complete response ie, the first instance when a subject has a reappearance of oral ulcers following a complete response, during the Placebo-controlled Treatment Phase
Time frame
week 1, 2, 4, 6, 8, 10, 12Sponsors and contacts
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Source ClinicalTrials.gov