search
Back to results

A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

Primary Purpose

Primary Sjogren's Syndrome

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Telitacicept 80 mg
Telitacicept 160 mg
Placebo
Sponsored by
RemeGen Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sjogren's Syndrome focused on measuring primary Sjogren's Syndrome, pSS, RC18

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Written informed consent provided. Males and females, 18-70 years of age. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016). Anti-SSA antibody tested positive at screening. ESSDAI score ≥ 5 at screening. Main Exclusion Criteria: Secondary Sjogren's syndrome. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR < 60 ml/min, serum creatinine > 2 mg/dL, or proteinuria > 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC < 60% or DLCO < 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening. Received live vaccine within 28 days prior to randomization. Active hepatitis or history of severe liver diseases. HIV positive. Patients with malignant tumors. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer. Nursing or pregnant female, or male or female who prepared for parenthood during the study. Any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Anhui Provincial HospitalRecruiting
  • The First Affiliated Hospital of Wannan Medical CollegeRecruiting
  • Beijing HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Peking University Shougang HospitalRecruiting
  • The First Hospital Affiliated to the Army Medical UniversityRecruiting
  • The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Sun Yat-sen Memorial HospitalRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Shenzhen People's HospitalRecruiting
  • Affiliated Hospital of Guilin Medical UniversityRecruiting
  • Guilin People's HospitalRecruiting
  • Liuzhou Workers' HospitalRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • The Affiliated Hospital of Zunyi Medical UniversityRecruiting
  • Affiliated Hospital of Hebei UniversityRecruiting
  • The Second Affiliated Hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Harbin Medical UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The First People's Hospital of ChangdeRecruiting
  • Hunan Provincial People's HospitalRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • The First People's Hospital of ChenzhouRecruiting
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyRecruiting
  • The Second People's Hospital of ChangzhouRecruiting
  • Jiangsu Province HospitalRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • First Affiliated Hospital of Gannan Medical UniversityRecruiting
  • Jiangxi Provincial People's HospitalRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • Jiangxi Pingxiang People's HospitalRecruiting
  • Jilin Province People's HospitalRecruiting
  • Yanbian University Hospital (Yanbian Hospital)Recruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • The First Hospital of China Medical UniversityRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Shandong Provincial HospitalRecruiting
  • Jining No 1 People's HospitalRecruiting
  • Yantai Yuhuangding HospitalRecruiting
  • Yantaishan HospitalRecruiting
  • Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
  • Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of MedicineRecruiting
  • Second Hospital of Shanxi Medical UniversityRecruiting
  • Shanxi Bethune HospitalRecruiting
  • Shanxi Provincial People's HospitalRecruiting
  • West China Hospital Sichuan UniversityRecruiting
  • Mianyang Central HospitalRecruiting
  • Affiliated Hospital of North Sichuan Medical CollegeRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
  • The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • The First People's Hospital of Yunnan ProvinceRecruiting
  • The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Huzhou Third Municipal HospitalRecruiting
  • The Second Hospital of JiaxingRecruiting
  • Jinhua Municipal Central HospitalRecruiting
  • Ningbo Medical Center (Lihuili Hospital)Recruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • The People's Hospital of WenzhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Telitacicept 80 mg

Telitacicept 160 mg

Placebo

Arm Description

Subjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.

Subjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.

Subjects will be given subcutaneous placebo once a week for 24-48 weeks. Subjects who are randomized to the placebo group are allowed to be transferred to either Telitacicept 80 mg or Telitacicept 160 mg after Week 24 by the investigator. Subjects and investigators are blinded throughout the study.

Outcomes

Primary Outcome Measures

Change from baseline in ESSDAI score
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.

Secondary Outcome Measures

Change from baseline in ESSDAI score
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.
Percentage of subjects with ESSDAI score decreased from baseline by at least 3 points
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease
Percentage of subjects with ESSDAI score < 5
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.
Percentage of subjects with ESSPRI score decreased from baseline by at least 1 point or 15%
The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported, subjective symptom index for primary Sjögren's syndrome. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains.
Change from baseline in MFI-20
The multidimensional fatigue inventory (MFI-20) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. Each question is scored from one to five and each dimension consists of five questions. The dimensional score consequently ranges from 4 to 20 (a higher score indicates more fatigue).
Incidence of AEs, SAEs
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death; is life-threatening experience; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/ birth defect; or any other important medical event that may not be immediately life-threatening or result in death or hospitalization but may require intervention to prevent one of the other serious outcomes listed in the definition above.

Full Information

First Posted
December 29, 2022
Last Updated
October 10, 2023
Sponsor
RemeGen Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05673993
Brief Title
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
Official Title
A Phase Ⅲ, Multi-center, Randomized, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Subcutaneous Telitacicept in Subjects With Active Primary Sjogren's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen 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
The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.
Detailed Description
This is a phase Ⅲ, multi-center, randomized, placebo-controlled, study. Subjects with active primary Sjogren's Syndrome (pSS) will be randomized to receive subcutaneous Telitacicept 80 mg, Telitacicept 160 mg or placebo weekly for a total of 48 weeks. Subjects are allowed to be transferred to another group after Week 24 by the investigator so that those randomized to the placebo group are able to receive either Telitacicept 80 mg or Telitacicept 160 mg afterwards. Subjects who are randomized to Telitacicept 80 mg and Telitacicept 160 mg groups will remain in the previous treatment group even if the investigator chooses to transfer them. Subjects and investigators are blinded throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjogren's Syndrome
Keywords
primary Sjogren's Syndrome, pSS, RC18

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telitacicept 80 mg
Arm Type
Experimental
Arm Description
Subjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.
Arm Title
Telitacicept 160 mg
Arm Type
Experimental
Arm Description
Subjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be given subcutaneous placebo once a week for 24-48 weeks. Subjects who are randomized to the placebo group are allowed to be transferred to either Telitacicept 80 mg or Telitacicept 160 mg after Week 24 by the investigator. Subjects and investigators are blinded throughout the study.
Intervention Type
Biological
Intervention Name(s)
Telitacicept 80 mg
Other Intervention Name(s)
RC 18 80 mg
Intervention Description
Telitacicept 80 mg subcutaneously once a week.
Intervention Type
Biological
Intervention Name(s)
Telitacicept 160 mg
Other Intervention Name(s)
RC 18 160 mg
Intervention Description
Telitacicept 160 mg subcutaneously once a week.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will be given subcutaneous placebo once a week.
Primary Outcome Measure Information:
Title
Change from baseline in ESSDAI score
Description
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in ESSDAI score
Description
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.
Time Frame
Week 48
Title
Percentage of subjects with ESSDAI score decreased from baseline by at least 3 points
Description
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease
Time Frame
Week 24 & Week 48
Title
Percentage of subjects with ESSDAI score < 5
Description
The EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. It includes 12 domains (ie, organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular, constitutional, lymphadenopathic, biological). Each domain is divided into 3-4 levels of activity (no, low, moderate, high). Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease.
Time Frame
Week 24 & Week 48
Title
Percentage of subjects with ESSPRI score decreased from baseline by at least 1 point or 15%
Description
The EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported, subjective symptom index for primary Sjögren's syndrome. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains.
Time Frame
Week 24 & Week 48
Title
Change from baseline in MFI-20
Description
The multidimensional fatigue inventory (MFI-20) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. Each question is scored from one to five and each dimension consists of five questions. The dimensional score consequently ranges from 4 to 20 (a higher score indicates more fatigue).
Time Frame
Week 24 & Week 48
Title
Incidence of AEs, SAEs
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death; is life-threatening experience; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/ birth defect; or any other important medical event that may not be immediately life-threatening or result in death or hospitalization but may require intervention to prevent one of the other serious outcomes listed in the definition above.
Time Frame
Up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Written informed consent provided. Males and females, 18-70 years of age. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016). Anti-SSA antibody tested positive at screening. ESSDAI score ≥ 5 at screening. Main Exclusion Criteria: Secondary Sjogren's syndrome. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR < 60 ml/min, serum creatinine > 2 mg/dL, or proteinuria > 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC < 60% or DLCO < 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening. Received live vaccine within 28 days prior to randomization. Active hepatitis or history of severe liver diseases. HIV positive. Patients with malignant tumors. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer. Nursing or pregnant female, or male or female who prepared for parenthood during the study. Any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghua Xiao
Phone
86-010-58076833
Email
binghua.xiao@remegen.com
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital Affiliated to the Army Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Guilin People's Hospital
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Liuzhou Workers' Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Changde
City
Changde
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Chenzhou
City
Chenzhou
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
City
Baotou
State/Province
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Name
The Second People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
Yanbian University Hospital (Yanbian Hospital)
City
Yanji
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Jining No 1 People's Hospital
City
Jining
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Yantaishan Hospital
City
Yantai
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Huzhou Third Municipal Hospital
City
Huzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Jinhua Municipal Central Hospital
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Ningbo Medical Center (Lihuili Hospital)
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Wenzhou
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

We'll reach out to this number within 24 hrs