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

Primary Purpose

Behçet Disease

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hemay005
Hemay005
Placebo
Sponsored by
Tianjin Hemay Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behçet Disease focused on measuring Behçet Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
  • 2.Male and female subjects 18~75(inclusive) years of age at the time of signing the informed consent form.
  • 3.Diagnosed with Behçet's disease meeting the International Study Group (ISG) criteria (2013).
  • 4.Subjects must have at least 2 oral ulcers at V1, and:

    1. at least 2 oral ulcers at V2 if V2 occurs at least 14 days after Visit 1, OR
    2. at least 3 oral ulcers at V2 if V2 occurs at least 0~42 days after Visit 1.
  • 5. According to the site investigator judgement, subject is suitable to the systemic but not topical treatment of oral ulcer considering the severity and affected area of the disease OR the oral ulcer cannot be well controlled by topical treatment and have to take the systemic treatment.
  • 6.All females of childbearing potential (FCBP) and male subjects who did not receive the vasectomy must take effective contraceptive measures.

Exclusion Criteria:

  • 1.subject has the BD related major organ activity lesions requiring immunosuppressive therapy- pulmonary, vascular, gastrointestinal, and central nervous systems (eg, meningoencephalitis) manifestations, etc. However:

    1. Previous major organ involvement is allowed if it occurred at least one years prior to screening visit and is not active at time of enrollment.
    2. Subjects with BD-related arthritis and BD-skin manifestations are also allowed
  • 2. Any clinically significant heart disease (e.g., but not limited to unstable ischemic heart disease, New York Heart Association(NYHA) class III / IV left ventricular failure, or myocardial infarction) or clinically significant 12 lead ECG abnormalities found during screening, which, according to the investigator's judgment, may put the patient at safety risk or may interfere with the investigator;
  • 3. subjects who current receiving immunotherapy including:

    1. 7 days prior to Visit 2 (randomization) for colchicine.
    2. 10 days prior to Visit 2 (randomization) for azathioprine, mycophenolate mofetil, baricitinib or Tofacitinib.
    3. 4 weeks prior to visit 2(randomization) for cyclosporin, methotrexate, cyclophosphamide, thalidomide, and dapsone.
    4. At least 5 terminal half-lives for all biologics, including,within:

      1. Four weeks prior to visit 2(randomization) for etanercept.
      2. Eight weeks prior to visit 2(randomization) for infliximab.
      3. Ten weeks prior to visit 2(randomization) for adalimumab, golimumab, abatacept, and tocilizumab.
      4. Six months prior to visit 2(randomization) for secukinumab.
  • 4.Having received intra-articular or parenteral corticosteroids within 6 weeks (42 days) prior to Visit 2.
  • 5.Laboratory examination of V1 in screening period:

    1. Hemoglobin ≤ 85g / L;
    2. The white blood cell (WBC) count was less than 3.0 × 10^9 / L or more than 14 × 10^9 / L;
    3. Platelet < 100 × 10^9 / L;
    4. Serum creatinine > 1.5mg/dl (> 132.6 μ mol / L);
    5. Total bilirubin > 2.0 mg / dl (> 34.2 μ mol / L);
    6. The Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) were higher than 1.5 times of the upper limit of normal value.
  • 6.subjects who received strong cytochrome P450 enzyme inducer within 4 weeks prior to visit2.
  • 7.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C and herpes zoster, histoplasmosis, coccidiomycosis, but excluding onychomycosis) , judged by investigator,may put the patient at safety risk.
  • 8.Clinically significant abnormality on chest radiograph or CT,judged by investigator, may put the patient at safety risk.
  • 9.History of transplantation and immunodeficiency disease, including those subject has a positive test for human immunodeficiency virus (HIV).
  • 10.subject who use of any investigational products of clinical trials within 4 weeks or within 5 pharmacokinetic/pharmacodynamic half-lives prior to randomization, whichever is longer;
  • 11.known to be allergic or allergic to the investigational products or ingredients;
  • 12.History of alcohol or drug abuse, or a history of mental illness;
  • 13.Subjects with severe, progressive, or uncontrolled disease, judged by the investigator, who maybe at risk if participate this study or those subjects whose participation may influence the interpretation of study results.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui provincial hospital
  • Beijing hospital
  • Peking Union Medical College Hospital
  • Peking University First Hospital
  • Peking University People's Hospital
  • Peking University Shougang Hospital
  • Xuanwu Hospital Capital Medical University
  • The First Affiliated Hospital of Xiamen University
  • Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
  • The University of Hong Kong-Shenzhen Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The Second Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of science and technology
  • Jiangsu Provincial Hospital
  • The First Affiliated Hospital of Soochow University
  • The Affiliated Hospital of Xuzhou Medical University
  • Jiu Jiang NO.1 people's Hospital
  • Jiangxi Pingxiang people's Hospital
  • China-Japan Union Hospital of Jilin University
  • Jilin Provincial People's Hospital
  • Linyi people's Hospital
  • Huashan Hospital Affiliated to Fudan University
  • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Tongji Hospital Of Tongji University Tang Jianping
  • Zhongshan Hospital Affiliated to Fudan University
  • The First Affiliated Hospital of Chengdu Medical College
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • First Affiliated Hospital,Zhejiang University School of Medicine
  • Zhejiang Provincial People's Hospital
  • The First Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Hemay005 high dose group

Hemay005 lower dose group

Placebo

Arm Description

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 12 weeks.

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 12 weeks.

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 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Complete response rate for oral ulcers
Complete response rate for oral ulcers at day 3, day 7 and Week 12
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
change of the number of oral ulcers
Change from baseline in the number of oral ulcers at Week 12
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
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
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 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
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
change of BD Current Activity Form(BDCAF)
change from baseline in the total score of the BDCAF questionnaire at week 12
change of Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
change from baseline in the total score of the MDHAQ questionnaire at week 12
change of short from health survey(SF-36)
change from baseline in the total score of the SF-36 questionnaire at week 12
Complete response rate for genital ulcers
Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline
change of the pain evaluation of genital ulcers
Change from baseline in the pain of genital ulcers as measured by VAS at Week 12
Change of the Behçet's syndrome activity score(BSAS) score
Change from Baseline in BSAS score at Week 12
Maximum Plasma Concentration (Cmax)
the population pharmacokinetic (popPK) characteristics Cmax of Hemay005 in BD patients
Minimum Plasma Concentration (Cmin)
the population pharmacokinetic (popPK) characteristics Cmin of Hemay005 in BD patients
Time to peak (Tmax)
the population pharmacokinetic (popPK) characteristics Tmax of Hemay005 in BD patients
Elimination half-life (T1/2)
the population pharmacokinetic (popPK) characteristics T1/2 of Hemay005 in BD patients
Area under drug time curve (AUC)
the population pharmacokinetic (popPK) characteristics AUC of Hemay005 in BD patients
Clearance (Cl)
the population pharmacokinetic (popPK) characteristics Cl of Hemay005 in BD patients
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
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

Full Information

First Posted
October 19, 2020
Last Updated
June 15, 2022
Sponsor
Tianjin Hemay Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04609397
Brief Title
A Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
Official Title
A Phase Ⅱ Study to Evaluate the Efficacy and Safety of Hemay005 in the Treatment of Behçet Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
The study purpose has been achieved
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Hemay Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behçet Disease
Keywords
Behçet Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemay005 high dose group
Arm Type
Experimental
Arm Description
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 12 weeks.
Arm Title
Hemay005 lower dose group
Arm Type
Experimental
Arm Description
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 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Hemay005
Other Intervention Name(s)
Phosphodiesterase 4 (PDE4) inhibitors
Intervention Description
Hemay005 tables 60mg bid p.o;
Intervention Type
Drug
Intervention Name(s)
Hemay005
Other Intervention Name(s)
Phosphodiesterase 4 (PDE4) inhibitors
Intervention Description
Hemay005 tables 45mg bid p.o
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo to Hemay005 tables bid p.o
Primary Outcome Measure Information:
Title
to evaluate the efficacy of Hemay005 in the treatment of Behçet's disease.
Description
Area under the curve (AUC) for the number of oral ulcers from baseline through Week 12
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving an oral ulcer complete response
Description
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
Title
Complete response rate for oral ulcers
Description
Complete response rate for oral ulcers at day 3, day 7 and Week 12
Time Frame
day 3, day 7 and week12
Title
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)
Description
Change from baseline in the pain of oral ulcers as measured by VAS at Week 12
Time Frame
week12
Title
change of the number of oral ulcers
Description
Change from baseline in the number of oral ulcers at Week 12
Time Frame
week12
Title
Time to oral ulcer resolution
Description
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
Title
Proportion of subjects achieving an oral ulcer complete response in the core-treatment phase
Description
Proportion of subjects achieving an oral ulcer complete response (oral ulcer-free) and who remain oral ulcer free during the core-treatment Phase
Time Frame
week12
Title
Number of oral ulcers who has a reappearance during the core-treatment phase
Description
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
Title
Time to oral ulcer reappearance during the core-treatment
Description
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
Title
change of the total score of Physician's Global Assessment(PGA)
Description
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
Title
change of BD Current Activity Form(BDCAF)
Description
change from baseline in the total score of the BDCAF questionnaire at week 12
Time Frame
week12
Title
change of Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Description
change from baseline in the total score of the MDHAQ questionnaire at week 12
Time Frame
week12
Title
change of short from health survey(SF-36)
Description
change from baseline in the total score of the SF-36 questionnaire at week 12
Time Frame
week12
Title
Complete response rate for genital ulcers
Description
Complete response rate for genital ulcers at Week 12 for subjects who had genital ulcers at Baseline
Time Frame
week12
Title
change of the pain evaluation of genital ulcers
Description
Change from baseline in the pain of genital ulcers as measured by VAS at Week 12
Time Frame
week12
Title
Change of the Behçet's syndrome activity score(BSAS) score
Description
Change from Baseline in BSAS score at Week 12
Time Frame
week12
Title
Maximum Plasma Concentration (Cmax)
Description
the population pharmacokinetic (popPK) characteristics Cmax of Hemay005 in BD patients
Time Frame
week24
Title
Minimum Plasma Concentration (Cmin)
Description
the population pharmacokinetic (popPK) characteristics Cmin of Hemay005 in BD patients
Time Frame
week24
Title
Time to peak (Tmax)
Description
the population pharmacokinetic (popPK) characteristics Tmax of Hemay005 in BD patients
Time Frame
week24
Title
Elimination half-life (T1/2)
Description
the population pharmacokinetic (popPK) characteristics T1/2 of Hemay005 in BD patients
Time Frame
week24
Title
Area under drug time curve (AUC)
Description
the population pharmacokinetic (popPK) characteristics AUC of Hemay005 in BD patients
Time Frame
week24
Title
Clearance (Cl)
Description
the population pharmacokinetic (popPK) characteristics Cl of Hemay005 in BD patients
Time Frame
week24
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Description
the Incidence of Treatment-Emergent Adverse Events of Hemay005 in BD patients with different dosing group
Time Frame
week24
Title
the number of subjects who terminated hemay005 prematurely due to adverse events (AE) [Safety and Tolerability])
Description
the number of subjects who terminated hemay005 prematurely due to adverse events (AE) in BD patients with different dosing group
Time Frame
week24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted. 2.Male and female subjects 18~75(inclusive) years of age at the time of signing the informed consent form. 3.Diagnosed with Behçet's disease meeting the International Study Group (ISG) criteria (2013). 4.Subjects must have at least 2 oral ulcers at V1, and: at least 2 oral ulcers at V2 if V2 occurs at least 14 days after Visit 1, OR at least 3 oral ulcers at V2 if V2 occurs at least 0~42 days after Visit 1. 5. According to the site investigator judgement, subject is suitable to the systemic but not topical treatment of oral ulcer considering the severity and affected area of the disease OR the oral ulcer cannot be well controlled by topical treatment and have to take the systemic treatment. 6.All females of childbearing potential (FCBP) and male subjects who did not receive the vasectomy must take effective contraceptive measures. Exclusion Criteria: 1.subject has the BD related major organ activity lesions requiring immunosuppressive therapy- pulmonary, vascular, gastrointestinal, and central nervous systems (eg, meningoencephalitis) manifestations, etc. However: Previous major organ involvement is allowed if it occurred at least one years prior to screening visit and is not active at time of enrollment. Subjects with BD-related arthritis and BD-skin manifestations are also allowed 2. Any clinically significant heart disease (e.g., but not limited to unstable ischemic heart disease, New York Heart Association(NYHA) class III / IV left ventricular failure, or myocardial infarction) or clinically significant 12 lead ECG abnormalities found during screening, which, according to the investigator's judgment, may put the patient at safety risk or may interfere with the investigator; 3. subjects who current receiving immunotherapy including: 7 days prior to Visit 2 (randomization) for colchicine. 10 days prior to Visit 2 (randomization) for azathioprine, mycophenolate mofetil, baricitinib or Tofacitinib. 4 weeks prior to visit 2(randomization) for cyclosporin, methotrexate, cyclophosphamide, thalidomide, and dapsone. At least 5 terminal half-lives for all biologics, including,within: Four weeks prior to visit 2(randomization) for etanercept. Eight weeks prior to visit 2(randomization) for infliximab. Ten weeks prior to visit 2(randomization) for adalimumab, golimumab, abatacept, and tocilizumab. Six months prior to visit 2(randomization) for secukinumab. 4.Having received intra-articular or parenteral corticosteroids within 6 weeks (42 days) prior to Visit 2. 5.Laboratory examination of V1 in screening period: Hemoglobin ≤ 85g / L; The white blood cell (WBC) count was less than 3.0 × 10^9 / L or more than 14 × 10^9 / L; Platelet < 100 × 10^9 / L; Serum creatinine > 1.5mg/dl (> 132.6 μ mol / L); Total bilirubin > 2.0 mg / dl (> 34.2 μ mol / L); The Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) were higher than 1.5 times of the upper limit of normal value. 6.subjects who received strong cytochrome P450 enzyme inducer within 4 weeks prior to visit2. 7.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C and herpes zoster, histoplasmosis, coccidiomycosis, but excluding onychomycosis) , judged by investigator,may put the patient at safety risk. 8.Clinically significant abnormality on chest radiograph or CT,judged by investigator, may put the patient at safety risk. 9.History of transplantation and immunodeficiency disease, including those subject has a positive test for human immunodeficiency virus (HIV). 10.subject who use of any investigational products of clinical trials within 4 weeks or within 5 pharmacokinetic/pharmacodynamic half-lives prior to randomization, whichever is longer; 11.known to be allergic or allergic to the investigational products or ingredients; 12.History of alcohol or drug abuse, or a history of mental illness; 13.Subjects with severe, progressive, or uncontrolled disease, judged by the investigator, who maybe at risk if participate this study or those subjects whose participation may influence the interpretation of study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhanguo Li, Doctor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Anhui provincial hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The University of Hong Kong-Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of science and technology
City
Baotou
State/Province
Inner Mongolia
Country
China
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiu Jiang NO.1 people's Hospital
City
Jiujiang
State/Province
Jiangxi
Country
China
Facility Name
Jiangxi Pingxiang people's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Jilin Provincial People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Linyi people's Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tongji Hospital Of Tongji University Tang Jianping
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Chengdu Medical College
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
First Affiliated Hospital,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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