Back to resultsEvaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA
Primary Purpose
Non-radiographic Axial Spondyloarthritis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
JS005
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-radiographic Axial Spondyloarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients who do not meet the modified New York criteria for AS in 1984; Meet the 2009 axSpA classification criteria recommended by International Assessment Society of Axial Spondyloarthritis (ASAS): inflammatory back pain for at least 3 months; Age of onset < 45 years; Sacroiliitis on MRI with≥ 1 axial spondyloarthritis features or HLA-B27 positive with ≥ 2 SpA features (MRI and X-ray of sacroiliac joint as confirmed by central readers).
- Objective signs of inflammation at screening: active inflammation of the sacroiliac joints on MRI and/or high sensitivity C-reactive protein (hsCRP) > upper limit of normal without other diagnoses to explain the MRI results or elevated hsCRP.
- Active axSpA at screening and baseline: assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10 scale) and spinal pain ≥ 4 (according to the 0-10 NRS scale, BASDAI question #2).
- Voluntarily participate in this clinical trial and sign the informed consent form.
- Male or female aged between 18 and 65 years (both inclusive) at the time of signing informed consent. Female subjects of childbearing age are required to have a confirmed negative result of urine and/or serum pregnancy test performed within 3 days before randomization and agree to use reliable contraceptive measures during the study; Male subjects and their female partners of childbearing age must agree to use reliable contraception during the study.
- Patients meet at least one of the following: 1) have an inadequate or ineffective response to NSAIDs, 2) have been intolerant to at least one dose of NSAIDs, 3) have contraindications to NSAIDs therapy. Inadequate or ineffective response to NSAIDs is defined as no remission after continuous treatment with standard doses of at least 2 NSAIDs for a total of no less than 4 weeks and no less than 2 weeks for each NSAID.
- Patients regularly taking NSAIDs as part of their AS therapy are required to maintain a stable dose for at least 2 weeks prior to randomization.
- Patients using tumor necrosis factor α (TNFα) inhibitors must have experienced an inadequate response to the standard treatment dose for at least 3 months, or have been intolerant to TNFα inhibitors.
Exclusion Criteria:
- Unable or unwilling to undergo MRI.
- Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptor.
- Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization.
- Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization.
- Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors.
- Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.
Sites / Locations
- Anhui Provincial Hospital
- The First Affiliated Hospital of Xiamen University
- Sun Yat-sen Memorial Sun Yat-sen University
- Nanfang Hospital of Nanfang Medical UniversityRecruiting
- Shantou University Medical Collge No.1 Affiliated Hospital
- Shenzhen People's Hospital
- Pking University Shenzhen Hospital
- The First Affiliated Hospital of Zhengzhou University
- Tongji Hospital,Tongji Medical College of HUST
- The Third Xiangya Hospital of Central South University
- The Second Xiangya Hospital of Central South University
- The Affilated Hospital of Inner Mongdlia Medical University
- The First Hospital of Jilin University
- The Second Affiliated Hospital of Dalian Medical University
- The First Affiliated Hospital of China Medical University
- Shengjing Hospital of China medical University
- Qilu Hospital of Shandong University
- Shanghai Changzheng Hospital
- First Affiliated Hospital of Shanxi Medical University
- West China Hospital, Sichuan University
- North Sichuan Medical College Affiliated Hospital
- Tianjin Medical University General Hospital
- People's Hospital of Xinjiang Uygur Autonomous Region
- First Affiliated Hospital of Kunming Medical University
- The Second Affiliated Hospital of Zhejiang University,School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
JS005 150 mg
Placebo 150 mg
JS005 300 mg
Placebo 300 mg
JS005 450 mg
Placebo 450
Arm Description
30 patients will be enrolled in this arm.
10 patients will be enrolled in this arm.
30 patients will be enrolled in this arm.
10 patients will be enrolled in this arm.
30 patients will be enrolled in this arm.
10 patients will be enrolled in this arm.
Outcomes
Primary Outcome Measures
The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria
at the end of treatment Week 16 .
Secondary Outcome Measures
ASAS20 response criteria
The proportion of patients meeting the ASAS20 response criteria at the end of treatment Week 16
ASAS 5/6 response criteria
The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16;
High-sensitivity C-reactive protein (hsCRP)
The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16
The inflammation score of the sacroiliac joint
The change from baseline in the inflammation score of the sacroiliac joint by MRI at the end of treatment Week 16
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16;
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16
Bath Ankylosing Spondylitis Functional Index (BASFI)
The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16
Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)
The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16
The patient's global assessment of disease activity
Numeric Rating Scale (NRS, ranging from 0 not active to 10 very active) will be used to evaluate the patient's global assessment of disease activity. Patient will be asked by one question: How active was your spondylitis on average during the last week？
The patient's assessment of inflammatory back pain intensity
NRS(ranging from 0 no pain to 10 most severe pain) will be used to assess the patient's inflammatory back pain intensity. The assessment is based on two questions: "Based on your assessment, please indicate How much pain of your spine due to AS do you have ?" and "Based on your assessment, please specify How much pain of your spine due to AS do you have at night?" When responding, the subject is to consider the average amount of pain in the last week.
ASAS partial remission criteria
The proportion of patients meeting ASAS partial remission criteria at the end of treatment Week 16
Full Information
NCT ID
NCT05242588
First Posted
November 30, 2021
Last Updated
February 6, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborators
Sponsor GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05242588
Brief Title
Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase II, Multicenter Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetics of Subcutaneous JS005 in Chinese Adults With Active Non-radiographic Axial Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborators
Sponsor GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active non-radiographic axial spondyloarthritis(nr-axSpA). Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate at Week 16 as well as safety profile will be provided by the study .
Detailed Description
This is a randomized, double-blind, placebo-controlled study. Approximately 120 patients who meet the eligibility criteria will be randomized to one of three treatment cohorts (JS005 150 mg, 300 mg, 450mg in a ratio of 1:1:1),then using secondary randomization method, 40 patients in each group will be randomized in a 3: 1 ratio to receive investigational product or placebo.
JS005 150mg Cohort: JS005 150 mg or placebo treatment(JS005:Placrbo=3:1) s.c. prefilled syringe (PFS) on Week 0, 1, 2, 3, 4,8 and 12
JS005 300mg Cohort: JS005 300 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 3 .JS005 450mg Cohort: JS005 450 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-radiographic Axial Spondyloarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
ParticipantCare ProviderInvestigator
Masking Description
Priticipant,Care provider and investigators are masked in this study
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JS005 150 mg
Arm Type
Experimental
Arm Description
30 patients will be enrolled in this arm.
Arm Title
Placebo 150 mg
Arm Type
Placebo Comparator
Arm Description
10 patients will be enrolled in this arm.
Arm Title
JS005 300 mg
Arm Type
Experimental
Arm Description
30 patients will be enrolled in this arm.
Arm Title
Placebo 300 mg
Arm Type
Placebo Comparator
Arm Description
10 patients will be enrolled in this arm.
Arm Title
JS005 450 mg
Arm Type
Experimental
Arm Description
30 patients will be enrolled in this arm.
Arm Title
Placebo 450
Arm Type
Placebo Comparator
Arm Description
10 patients will be enrolled in this arm.
Intervention Type
Biological
Intervention Name(s)
JS005
Other Intervention Name(s)
Recombinant humanized anti-IL-17A monoclonal antibody injection
Intervention Description
30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Primary Outcome Measure Information:
Title
The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria
Description
at the end of treatment Week 16 .
Time Frame
From week 0 to week 16
Secondary Outcome Measure Information:
Title
ASAS20 response criteria
Description
The proportion of patients meeting the ASAS20 response criteria at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
ASAS 5/6 response criteria
Description
The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16;
Time Frame
From week 0 to week 16
Title
High-sensitivity C-reactive protein (hsCRP)
Description
The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
The inflammation score of the sacroiliac joint
Description
The change from baseline in the inflammation score of the sacroiliac joint by MRI at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
Description
The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16;
Time Frame
From week 0 to week 16
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)
Description
The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Description
The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16
Time Frame
From week 0 to week 16
Title
The patient's global assessment of disease activity
Description
Numeric Rating Scale (NRS, ranging from 0 not active to 10 very active) will be used to evaluate the patient's global assessment of disease activity. Patient will be asked by one question: How active was your spondylitis on average during the last week？
Time Frame
From week 0 to week 16
Title
The patient's assessment of inflammatory back pain intensity
Description
NRS(ranging from 0 no pain to 10 most severe pain) will be used to assess the patient's inflammatory back pain intensity. The assessment is based on two questions: "Based on your assessment, please indicate How much pain of your spine due to AS do you have ?" and "Based on your assessment, please specify How much pain of your spine due to AS do you have at night?" When responding, the subject is to consider the average amount of pain in the last week.
Time Frame
From week 0 to week 16
Title
ASAS partial remission criteria
Description
The proportion of patients meeting ASAS partial remission criteria at the end of treatment Week 16
Time Frame
From week 0 to week 16
Other Pre-specified Outcome Measures:
Title
Pharmacokinetic endpoint
Description
• Population pharmacokinetic analysis of plasma concentrations will be performed to explore the exposure of JS005 in patients and the influencing factors of exposure
Time Frame
From Baseline to week 24,Total 24 weeks
Title
Pharmacodynamic endpoint
Description
• Concentrations and the changes of free and/or total IL-17 in serum before and after administration.
Time Frame
From Baseline to week 24,Total 24 weeks
Title
Immunogenicity endpoint
Description
• Anti-drug antibody (ADA), for the ADA positive samples, it is necessary to test the titer and determine whether it is a neutralizing antibody (Nab).
Time Frame
From Baseline to week 24,Total 24 weeks
Title
Safety evaluation
Description
Safety evaluation will be documented as numbers of adverse event(AE).
Time Frame
From V1 to V12, Total 36 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who do not meet the modified New York criteria for AS in 1984; Meet the 2009 axSpA classification criteria recommended by International Assessment Society of Axial Spondyloarthritis (ASAS): inflammatory back pain for at least 3 months; Age of onset < 45 years; Sacroiliitis on MRI with≥ 1 axial spondyloarthritis features or HLA-B27 positive with ≥ 2 SpA features (MRI and X-ray of sacroiliac joint as confirmed by central readers).
Objective signs of inflammation at screening: active inflammation of the sacroiliac joints on MRI and/or high sensitivity C-reactive protein (hsCRP) > upper limit of normal without other diagnoses to explain the MRI results or elevated hsCRP.
Active axSpA at screening and baseline: assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10 scale) and spinal pain ≥ 4 (according to the 0-10 NRS scale, BASDAI question #2).
Voluntarily participate in this clinical trial and sign the informed consent form.
Male or female aged between 18 and 65 years (both inclusive) at the time of signing informed consent. Female subjects of childbearing age are required to have a confirmed negative result of urine and/or serum pregnancy test performed within 3 days before randomization and agree to use reliable contraceptive measures during the study; Male subjects and their female partners of childbearing age must agree to use reliable contraception during the study.
Patients meet at least one of the following: 1) have an inadequate or ineffective response to NSAIDs, 2) have been intolerant to at least one dose of NSAIDs, 3) have contraindications to NSAIDs therapy. Inadequate or ineffective response to NSAIDs is defined as no remission after continuous treatment with standard doses of at least 2 NSAIDs for a total of no less than 4 weeks and no less than 2 weeks for each NSAID.
Patients regularly taking NSAIDs as part of their AS therapy are required to maintain a stable dose for at least 2 weeks prior to randomization.
Patients using tumor necrosis factor α (TNFα) inhibitors must have experienced an inadequate response to the standard treatment dose for at least 3 months, or have been intolerant to TNFα inhibitors.
Exclusion Criteria:
Unable or unwilling to undergo MRI.
Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptor.
Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization.
Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization.
Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors.
Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengbo Jia, Bachelor
Phone
861085172616/18547265054
Email
chengbo_jia@junshipharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiangnian Liu, Bachelor
Phone
18733176288
Email
jiangnian_liu@junshipharma.com
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Li, M.D.
Phone
13866795533
Email
lxmcsyi@163.com
First Name & Middle Initial & Last Name & Degree
Xiaomei Li, M.D.
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guixiu Shi, M.D.
Phone
+8613600932661
Email
gshi@xmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Guixiu Shi, M.D.
Facility Name
Sun Yat-sen Memorial Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donghui Zhen, M.D.
Phone
13711119612
Email
zhenggouyang@sina.com
First Name & Middle Initial & Last Name & Degree
Donghui Zhen, M.D.
Facility Name
Nanfang Hospital of Nanfang Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yang, M.D.
Phone
13802911770
Email
minyanggz@163.com
First Name & Middle Initial & Last Name & Degree
Min Yang, M.D.
Facility Name
Shantou University Medical Collge No.1 Affiliated Hospital
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyi Hou, M.D.
Phone
13750428653
Email
houzhiduo@foxmail.com
First Name & Middle Initial & Last Name & Degree
Zhiyi Hou, M.D.
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongzhou Liu, M.D.
Phone
13802257360
Email
liu_dz2001@sina.com
First Name & Middle Initial & Last Name & Degree
Dongzhou Liu, M.D.
Facility Name
Pking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingwen Wang, M.D.
Phone
13688802429
Email
wqw_sw@163.com
First Name & Middle Initial & Last Name & Degree
Qingwen Wang, M.D.
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
361001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyun Liu, M.D.
Phone
+8613837192659
Email
fccliusy2@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shengyun Liu, M.D.
Facility Name
Tongji Hospital,Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linli Dong, M.D.
Phone
13627251132
Email
fsklcywsy@163.com
First Name & Middle Initial & Last Name & Degree
Linli Dong, M.D.
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
361001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Sun, M.D.
Phone
+8613574853650
Email
sunjian105@sina.com
First Name & Middle Initial & Last Name & Degree
Jian Sun, M.D.
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Xie, M.D.
Phone
13016161226
Email
mecca0000@163.com
First Name & Middle Initial & Last Name & Degree
Xi Xie, M.D.
Facility Name
The Affilated Hospital of Inner Mongdlia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
100000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbin Li, M.D.
Phone
13948536552
Email
Lhbwb73@126.com
First Name & Middle Initial & Last Name & Degree
Hongbin Li, M.D.
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Jia, M.D.
Phone
15843079623
Email
jzyd0197@163.com
First Name & Middle Initial & Last Name & Degree
Zhenyu Jia, M.D.
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116023
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodan Kong, M.D.
Phone
17709876336
Email
xiaodankong2008@sina.com
First Name & Middle Initial & Last Name & Degree
Xiaodan Kong, M.D.
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinting Yang, M.D.
Phone
13904003875
Email
yangpingtingting@163.com
First Name & Middle Initial & Last Name & Degree
Pinting Yang, M.D.
Facility Name
Shengjing Hospital of China medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Wang, M.D.
Phone
18940251629
Email
wangxf@sj-hospital.com
First Name & Middle Initial & Last Name & Degree
Xiaofei Wang, M.D.
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
030001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaxiang Liu, M.D.
Phone
18560081680
Email
lzzlhx63@163.com
First Name & Middle Initial & Last Name & Degree
Huaxiang Liu, M.D.
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huji Xu, M.D.
Phone
+8613671609764
Email
huji_xu@tsinghua.edu.cn
First Name & Middle Initial & Last Name & Degree
Huji Xu, M.D.
Facility Name
First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
650032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zili Fu, M.D.
Phone
13834676095
Email
fuzili72@163.com
First Name & Middle Initial & Last Name & Degree
Zili Fu, M.D.
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
600041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yi Liu, M.D.
Phone
18980602061
Email
yi2006liu@163.com
First Name & Middle Initial & Last Name & Degree
Yi Liu, M.D.
Facility Name
North Sichuan Medical College Affiliated Hospital
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Yuan, M.D.
Phone
+8615983777907
Email
15983777907@139.com
First Name & Middle Initial & Last Name & Degree
Guohua Yuan, M.D.
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wei, M.D.
Phone
13920182411
Email
tjweiwei2003@163.com
First Name & Middle Initial & Last Name & Degree
Wei Wei, M.D.
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
8300001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Wu, M.D.
Phone
13999265917
Email
wwlj330@126.com
First Name & Middle Initial & Last Name & Degree
Lijun Wu, M.D.
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
250063
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xu, M.D.
Phone
13888566797
Email
jianxu777@126.com
First Name & Middle Initial & Last Name & Degree
Jian Xu, M.D.
Facility Name
The Second Affiliated Hospital of Zhejiang University,School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
450052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaxiang Wu, M.D.
Phone
13757118395
Email
wuhx8855@sina.com
First Name & Middle Initial & Last Name & Degree
Huaxiang Wu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Learn more about this trial
Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA
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