Behçet's DiseasePhase 3NCT06145893
A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
A Phase 3 study testing Hemay005 in people with Behçet's Disease, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 22 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Behçet's Disease
- What is being tested?
- Hemay005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 22 sitesChina
- Study dates
- 13 Nov 2023to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 V1 (screening), and:
- at least 2 oral ulcers present at V2 (the day of randomization) when V2 occurs 14-56 days after V1; OR
- at least 3 oral ulcers present at V2 (the day of randomization) when V2 occurs 0-13 days after V1;
Show all 9Show fewer
- Applicability of systemic treatment for oral ulcers: Based on the severity of the disease and the involved area, the investigator determines that the patient's oral ulceration is not suitable for topical treatment or that the patient's oral ulceration cannot be effectively controlled by topical treatment, so that systemic treatment is to be used;
- Throughout the study period from signing of ICF through 3 months after the last study dose, women of childbearing potential and male subjects who have not undergone vasoligation should use effective contraceptive measures, including vasoligation, abstinence, intrauterine device (IUD), hormones (oral, patches, rings, injections, implants) and barrier methods (diaphragms, cervical caps, sponges, condoms);
- Being able to comply with the follow-up schedule and other protocol requirements.
Who cannot join
- 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;
- Use of the following immunomodulatory therapies:
- Colchicine within 7 days prior to randomization;
- Perazathioprine, mycophenolate, baritinib, or tofacitinib within 10 days prior to randomization;
- Cyclosporine, methotrexate, cyclophosphamide, thalidomide, or dapsone within 4 weeks (28 days) prior to randomization;
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- Biologics within 5 half-lives prior to randomization, e.g.:
- Etanercept within 4 weeks prior to randomization;
- Infliximab or leflunomide within 8 weeks prior to randomization;
- Adalimumab, golimumab, abatacept, or tolizumab within 10 weeks prior to randomization;
- Secukinumab within 6 months prior to randomization;
- Intraarticular or systemic corticosteroid treatment prior to randomization and within 5 pharmacokinetic/pharmacodynamic half-lives; Note: For subjects with eye symptoms, glucocorticoid eye drops are allowed throughout the trial (except for within 24 hours prior to a trial visit).
- Chinese patent medicines with immunomodulatory effect within 2 weeks prior to randomization; any Chinese pate nt medicines or decoctions within 2 weeks prior to randomization that might affect efficacy evaluation, or containing sinomenine, total glucoside of paeony, or tripterygium wilfordii, etc.;
- Laboratory tests:
- Hemoglobin ≤85g/L;
- White blood cell count <3.0×10^9/L or >14×10^9/L;
- Platelets <100×10^9/L;
- Serum creatinine >1.5 mg/dL (>132.6 μmol/L);
- Total bilirubin of >2.0 mg/dL (>34.2 μmol/L);
- Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥1.5×ULN; Note: The above tests can be repeated at most once during the screening period. If the result within 2 weeks prior to randomization falls into the specified range, the subject is eligible for the study;
- Use of potent inducers of cytochrome P450 enzymes (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin sodium) within 4 weeks prior to randomization;
- Other autoimmune diseases or chronic inflammatory diseases associated with immunity, e.g., rheumatic fever, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, multiple sclerosis, Sjögren's syndrome, and inflammatory bowel disease;
- Currently active infections or recurrent bacterial, fungal, viral, mycobacterial or other infectious diseases (including but not limited to tuberculosis, atypical mycobacteriosis, hepatitis B, hepatitis C, herpes zoster, histoplasmosis, and coccidiosis; however, onychomycosis is excluded), which, at the investigator's discretion, may put the subject at safety risk; Note: Subjects positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, or with a history of active mycobacterial infection of any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit should be excluded. Screening is permitted if the subject has been cured for at least 3 years prior to randomization with documentation available for verification;
- Clinically significant chest X-ray or CT abnormalities, which, at the investigator's discretion, may put the subject at safety risk; Note: If a chest X-ray or CT was performed within 3 months prior to V1, the examination may be omitted for V1;
- History of transplantation or immunodeficiency;
- Positive for human immunodeficiency virus (HIV) antibody or treponema pallidum antibody test;
- Currently having a malignant tumor, or a history of any malignant tumor within 5 years prior to screening (except for treatment-experienced squamous cell carcinoma in situ of the skin, basal cell carcinoma or cervical carcinoma in situ with no evidence of relapse within the past 12 months);
- Use of any clinical investigational product within 4 weeks prior to randomization or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer; Note: Subjects who have participated in HM005BD2S01 study are not eligible to participate in this trial;
- Known allergy to the study drug or any of its components or allergic constitution;
- A history of alcohol or drug abuse or dependence, or psychiatric disorder;
- Any conditions that may interfere with oral drug absorption, e.g., subtotal gastrectomy, clinically significant diabetic gastrointestinal disease, or certain types of bariatric surgery such as gastric bypass surgery, not including procedures that simply separate the stomach into separate chambers such as gastric banding surgery;
- Prior use of apremilast;
- Female subjects who are pregnant or breast feeding;
- Concomitant serious, progressive, or uncontrolled diseases, with which participation in the study may, at the investigator's discretion, put the subject at potential risk or affect the interpretation of study results.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Beijing Friendship hospital capital medical hospital
Beijing, Beijing Municipality
Yanying Liu
- Recruiting
Peking university first hospital
Beijing, Beijing Municipality
ZhuoLi Zhang
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Zhanguo Li, Dortor
- Recruiting
Peking university third hospital
Beijing, Beijing Municipality
RONG MU
- Recruiting
Xuanwu hospital capital medical university
Beijing, Beijing Municipality
Yi Zhao
- Recruiting
Jilin Province People's hospital
Changchun, Jilin
Lin Chen
- Recruiting
Guangdong second provincial central hospital
Guangzhou, Guangdong
Weiming Deng
- Recruiting
Sun Yat-Sen memorial hospital
Guangzhou, Guangdong
Lie Dai
- Recruiting
The third affiliated hospital sun yat-sen university
Guangzhou, Guangdong
Yunfeng Pan
- Recruiting
Affiliated hospital of Guilin Medical university
Guilin, Guangxi
Yuhong Shi
- Recruiting
The first affiliated hospital, Zhejiang University school of medicine
Hangzhou, Zhejiang
Jin Lin
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong
Zhenchun Zhang
- Recruiting
The first affiliated hospital of Nanchang university
Nanchang, Jiangsu
RUI WU
- Recruiting
Tongji hospital of Tongji university
Shanghai, Shanghai Municipality
Jianping Tang
- Recruiting
The university of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong
Ling Wu
- Not yet recruiting
The second hospital of Hebei medical university
Shijiazhuang, Hebei
Hongtao Jin
- Recruiting
The first affiliated hospital of Soochow university
Suzhou, Jiangsu
Jian Wu
- Not yet recruiting
Second hospital of shanxi medical university
Taiyuan, Shanxi
Xiaoxia Wang
- Recruiting
The first affiliated hospital of Wenzhou Medical university
Wenzhou
Li Sun
- Recruiting
The first affiliated hospital of Xiamen University
Xiamen, Fujian
Guixiu Shi
- Recruiting
Xinxiang Central hospital
Xinxiang, Henan
Wenqiang Fan
- Recruiting
The affiliated hospital of Xuzhou medical university
Xuzhou, Jiangsu
Songlou Yin
About this study
Official title: A Phase III Clinical Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
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.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-parallel controlled phase III clinical study. The study consists of four phases, namely the screening period, the core treatment period, the extension period, and the drug discontinuation observation period.
Screening period: All subjects will undergo a screening period for up to 8 weeks prior to the baseline visit (V2, randomization day, Day 0).
Core treatment period: Patients with Behçet's disease (BD) meeting the eligibility criteria upon screening will be randomized in a 1:1: 1 ratio to the Hemay005 Tablets 45 mg BID test group, Hemay005 Tablets 60 mg BID test group, or the placebo group. They will first be given escalating doses for 7 days; subsequently starting from Day 7, they will be given Hemay005 Tablets 45 mg BID or 60 mg BID or the placebo BID continuously until Week 12.
Extension period: Considering benefits for subjects in the placebo group, and to observe the efficacy and safety of long-term treatment, all subjects will enter a 40-week extension period at the end of the core treatment period. Subjects enrolled in the test groups for the core treatment period will continue treatment at the dose for the core treatment period for 40 weeks during the extension period. Subjects enrolled in the placebo group for the core treatment period will be randomized in a 1:1 ratio during the extension period to either the Hemay005 Tablets 45 mg BID test group or Hemay005 Tablets 60 mg BID test group for treatment for 40 weeks. For the first week of extended treatment, subjects previously enrolled in the placebo group will need to undergo the same dose titration phase as for the core treatment period (Days 0-6), so that the same dosing schedule as for the two treatment groups would be achieved by the 7th day, in an effort to mitigate the intolerabilities such as gastrointestinal reactions, thus further protecting subjects' safety. If, during the dose titration phase of the extension period or during extended treatment, the subject cannot tolerate the prescribed dose, this will be handled at the investigator's discretion using the same method as for the core treatment period.
Drug discontinuation observation period: All subjects in the study (including those who prematurely discontinued treatment for any reason) will be observed for 4 weeks following the end of the last study dose.
- Conditions
- Behçet's Disease
- Being tested
- Hemay005, Placebo
- Keywords
- Behçet's Disease
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005Drug
Also called Mufemilast, Phosphodiesterase 4 (PDE4) inhibitors
Hemay005 tables 60mg bid p.o;
Hemay005Drug
Also called Mufemilast, Phosphodiesterase 4 (PDE4) inhibitors
Hemay005 tables 45mg bid p.o;
PlaceboDrug
placebo to Hemay005 tables bid p.o
| Study group | Role | What they receive |
|---|---|---|
| Hemay005 high dose group | Experimental | In Core-treatment period, subject will take Hemay005 60mg twice daily for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 60mg twice daily for 40 weeks. Receives: Drug: Hemay005 |
| Hemay005 lower dose group | Experimental | In Core-treatment period, subject will take Hemay005 45mg twice daily for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 45mg twice daily for 40 weeks. Receives: Drug: Hemay005 |
| Placebo | Placebo comparator | In Core-treatment period, subject will take placebo for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 60mg or hemay005 45mg twice daily according to pre-allocation at randomization visit for 40 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessed by oral ulcers
Area under the curve (AUC) of the number of oral ulcers in BD patients from baseline to Week 12
Measured: week 12
Secondary outcomes (28)
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
Measured: week 12, 22, 32, 42, 52
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
Measured: week 12, 22, 32, 42, 52
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
Measured: week 12, 22, 32, 42, 52
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
Measured: week 12, 22, 32, 42, 52
efficacy assessed by BDCAF
Change from baseline in disease activity as measured by Behçet's Disease Current Activity scores (BD Current Activity Form) at Week 12，22，32，42，52
Measured: week 12, 22, 32, 42, 52
efficacy assessed by BSAS
Change from Baseline in Behçet's Syndrome Activity Score (BSAS) at Week 12，22，32，42，52
Measured: week 12, 22, 32, 42, 52
efficacy assessed by oral ulcers
Time to oral ulcer resolution (complete response), ie, the first instance when a subject has a complete response, during the Placebo-controlled Treatment Phase
Measured: week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by oral ulcers
Proportion of subjects with no oral ulcers following complete response, ie, the first time when a subject has a complete response, during the Placebo-controlled Treatment Phase
Measured: week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by oral ulcers
Number of oral 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
Measured: week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by oral ulcers
Time to recurrence of oral 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
Measured: week 1, 2, 4, 6, 8, 10, 12
efficacy of skin lesions assessed by PGA score
Change from baseline in the total score of the Static Physician's Global Assessment (PGA) of skin lesions (acne-like lesions, folliculitis and erythema nodosum) of BD at Week 12，22，32，42，52 in subjects who had BD skin lesions at baseline
Measured: week 12, 22, 32, 42, 52
efficacy assessed by oral ulcers
Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) by Week 6, after start of dosing, and who remain oral ulcer free for at least 6 additional weeks during the 12-week Placebo-controlled Treatment Phase
Measured: week 2, 4, 6, 8, 10, 12
Quality of life measured by BD QoL
Change from baseline in the BD QoL score at Week 12，22，32，42，52
Measured: week 12, 22, 32, 42, 52
Quality of life measured by SF-36
Change from baseline in SF-36 score at Week 12, 22，32，42，52
Measured: week 12, 22, 32, 42, 52
efficacy assessed by tender and/or swollen joints
Change from baseline in number of tender and/or swollen joints associated with BD at Week 12，22, 32, 42, and 52 in subjects who had BD-related tender and/or swollen joints at baseline;
Measured: week 12, 22, 32, 42, 52
efficacy assessed by gastrointestinal activity
Changes from baseline in Disease Activity Index for Intestinal Behçet's Disease (DAIBD) score at Weeks 12, 22, 32, 42, and 52
Measured: week 12, 22, 32, 42, 52
efficacy assessed by gastrointestinal symptoms
Changes from baseline in Global GI symptoms assessment at Weeks 12 and 52
Measured: week 1, 12, 52
efficacy assessed by biomarkers.
Changes from baseline in CRP and ESR at Weeks 12, 22, 32, 42, and 52;
Measured: week 12, 22, 32, 42, 52
efficacy assessed by eye symptoms.
Changes from baseline in best corrected visual acuity (BCVA) at Weeks 12, 22, 32, 42, and 52, and changes from baseline in improvement of inflammation (slit lamp and/or ophthalmoscopy/fundus photography optical coherence tomography (OCT), etc.) at Weeks 12 and 52
Measured: week 12, 22, 32, 42, 52
population pharmacokinetics (PopPK)
Area under the curve (AUC)
Measured: week 4, 12
population pharmacokinetics (PopPK)
Maximum Plasma Concentration (Cmax)
Measured: week 4, 12
population pharmacokinetics (PopPK)
Minimum Plasma Concentration (Cmin)
Measured: week 4, 12
population pharmacokinetics (PopPK)
Time to peak (Tmax)
Measured: week 4, 12
population pharmacokinetics (PopPK)
Elimination half-life (T1/2)
Measured: week 4, 12
population pharmacokinetics (PopPK)
Clearance (Cl)
Measured: week 4, 12
safety assessed by Type, frequency, severity and relationship with drug of AEs
Type, frequency, severity and relationship with Hemay005 of AEs
Measured: week 1, 2, 4, 6, 8, 10, 12, 22, 32, 43, 52, 56
safety and tolerability assessed by discontinuation due to AEs
Number of subjects prematurely discontinuing the investigational product due to AE
Measured: week 1, 2, 4, 6, 8, 10, 12, 22, 32, 43, 52, 56
safety and feasibility assessed by lab examinations
Frequency of clinically significant changes in vital signs, weight, laboratory findings, physical examination, and/or 12-lead ECG
Measured: week 1, 2, 4, 6, 8, 10, 12, 22, 32, 43, 52, 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start13 Nov 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhanguo Li, Doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145893
- Sponsor's protocol ID
- HM005BD3S01
- Status last verified
- Dec 2024
- First submitted
- 17 Nov 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
- ClinicalTrials.gov ID
- NCT06145893
- Acronym / sponsor ID
- HM005BD3S01
- Conditions
- Behçet's Disease
- Keywords
- Behçet's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, randomized, double-blind, placebo-parallel controlled phase III clinical study. The study consists of four phases, namely the screening period, the core treatment period, the extension period, and the drug discontinuation observation period.
Screening period: All subjects will undergo a screening period for up to 8 weeks prior to the baseline visit (V2, randomization day, Day 0).
Core treatment period: Patients with Behçet's disease (BD) meeting the eligibility criteria upon screening will be randomized in a 1:1: 1 ratio to the Hemay005 Tablets 45 mg BID test group, Hemay005 Tablets 60 mg BID test group, or the placebo group. They will first be given escalating doses for 7 days; subsequently starting from Day 7, they will be given Hemay005 Tablets 45 mg BID or 60 mg BID or the placebo BID continuously until Week 12.
Extension period: Considering benefits for subjects in the placebo group, and to observe the efficacy and safety of long-term treatment, all subjects will enter a 40-week extension period at the end of the core treatment period. Subjects enrolled in the test groups for the core treatment period will continue treatment at the dose for the core treatment period for 40 weeks during the extension period. Subjects enrolled in the placebo group for the core treatment period will be randomized in a 1:1 ratio during the extension period to either the Hemay005 Tablets 45 mg BID test group or Hemay005 Tablets 60 mg BID test group for treatment for 40 weeks. For the first week of extended treatment, subjects previously enrolled in the placebo group will need to undergo the same dose titration phase as for the core treatment period (Days 0-6), so that the same dosing schedule as for the two treatment groups would be achieved by the 7th day, in an effort to mitigate the intolerabilities such as gastrointestinal reactions, thus further protecting subjects' safety. If, during the dose titration phase of the extension period or during extended treatment, the subject cannot tolerate the prescribed dose, this will be handled at the investigator's discretion using the same method as for the core treatment period.
Drug discontinuation observation period: All subjects in the study (including those who prematurely discontinued treatment for any reason) will be observed for 4 weeks following the end of the last study dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemay005 high dose group | Experimental | Drug: Hemay005In Core-treatment period, subject will take Hemay005 60mg twice daily for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 60mg twice daily for 40 weeks. |
| Hemay005 lower dose group | Experimental | Drug: Hemay005In Core-treatment period, subject will take Hemay005 45mg twice daily for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 45mg twice daily for 40 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboIn Core-treatment period, subject will take placebo for 12 weeks, and in the following extend-treatment period, subject will take Hemay005 60mg or hemay005 45mg twice daily according to pre-allocation at randomization visit for 40 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 V1 (screening), and:
- Applicability of systemic treatment for oral ulcers: Based on the severity of the disease and the involved area, the investigator determines that the patient's oral ulceration is not suitable for topical treatment or that the patient's oral ulceration cannot be effectively controlled by topical treatment, so that systemic treatment is to be used;
Key exclusion criteria (34 listed)
- 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;
- Use of the following immunomodulatory therapies:
- Intraarticular or systemic corticosteroid treatment prior to randomization and within 5 pharmacokinetic/pharmacodynamic half-lives; Note: For subjects with eye symptoms, glucocorticoid eye drops are allowed throughout the trial (except for within 24 hours prior to a trial visit).
- Chinese patent medicines with immunomodulatory effect within 2 weeks prior to randomization; any Chinese pate nt medicines or decoctions within 2 weeks prior to randomization that might affect efficacy evaluation, or containing sinomenine, total glucoside of paeony, or tripterygium wilfordii, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemay005Also: Mufemilast, Phosphodiesterase 4 (PDE4) inhibitorsHemay005 tables 60mg bid p.o; | Drug | Hemay005 high dose group |
| Hemay005Also: Mufemilast, Phosphodiesterase 4 (PDE4) inhibitorsHemay005 tables 45mg bid p.o; | Drug | Hemay005 lower dose group |
| Placeboplacebo to Hemay005 tables bid p.o | Drug | Placebo |
Primary outcome
Efficacy assessed by oral ulcers
Time frame: week 12
Area under the curve (AUC) of the number of oral ulcers in BD patients from baseline to Week 12
28 secondary outcomes
efficacy assessed by oral ulcers
Time frame: week 12, 22, 32, 42, 52
pain of oral ulcers assessed by VAS
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by genital ulcers
Time frame: week 12, 22, 32, 42, 52
pain of genital ulcers assessed by VAS
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by BDCAF
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by BSAS
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by oral ulcers
Time frame: week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by oral ulcers
Time frame: week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by oral ulcers
Time frame: week 1, 2, 4, 6, 8, 10, 12
efficacy assessed by oral ulcers
Time frame: week 1, 2, 4, 6, 8, 10, 12
efficacy of skin lesions assessed by PGA score
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by oral ulcers
Time frame: week 2, 4, 6, 8, 10, 12
Quality of life measured by BD QoL
Time frame: week 12, 22, 32, 42, 52
Quality of life measured by SF-36
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by tender and/or swollen joints
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by gastrointestinal activity
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by gastrointestinal symptoms
Time frame: week 1, 12, 52
efficacy assessed by biomarkers.
Time frame: week 12, 22, 32, 42, 52
efficacy assessed by eye symptoms.
Time frame: week 12, 22, 32, 42, 52
population pharmacokinetics (PopPK)
Time frame: week 4, 12
population pharmacokinetics (PopPK)
Time frame: week 4, 12
population pharmacokinetics (PopPK)
Time frame: week 4, 12
population pharmacokinetics (PopPK)
Time frame: week 4, 12
population pharmacokinetics (PopPK)
Time frame: week 4, 12
population pharmacokinetics (PopPK)
Time frame: week 4, 12
safety assessed by Type, frequency, severity and relationship with drug of AEs
Time frame: week 1, 2, 4, 6, 8, 10, 12, 22, 32, 43, 52, 56
safety and tolerability assessed by discontinuation due to AEs
Time frame: week 1, 2, 4, 6, 8, 10, 12, 22, 32, 43, 52, 56
safety and feasibility assessed by lab examinations
Time frame: week 1, 2, 4, 6, 8, 10, 12, 22, 32, 43, 52, 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanguo Li, Doctor principal investigator
Peking University People's Hospital
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hemay005 in people with Behçet's Disease, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinfeng Lin (15790249669, linjinfeng@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessed by oral ulcers (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.