A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
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
1 other identifier
interventional
381
1 country
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2023
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2025
CompletedOctober 1, 2025
June 1, 2025
1.6 years
December 29, 2022
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 24
Secondary Outcomes (6)
Change from baseline in ESSDAI score
Week 48
Percentage of subjects with ESSDAI score decreased from baseline by at least 3 points
Week 24 & Week 48
Percentage of subjects with ESSDAI score < 5
Week 24 & Week 48
Percentage of subjects with ESSPRI score decreased from baseline by at least 1 point or 15%
Week 24 & Week 48
Change from baseline in MFI-20
Week 24 & Week 48
- +1 more secondary outcomes
Study Arms (3)
Telitacicept 80 mg
EXPERIMENTALSubjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.
Telitacicept 160 mg
EXPERIMENTALSubjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.
Placebo
PLACEBO COMPARATORSubjects 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.
Interventions
Telitacicept 80 mg subcutaneously once a week.
Telitacicept 160 mg subcutaneously once a week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
South China Hospital of Shenzhen University
Shenzhen, Guangdong, China
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
Guilin People's Hospital
Guilin, Guangxi, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou Workers' Hospital
Liuchow, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Hebei PetroChina Central Hospital
Langfang, Hebei, China
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First People's Hospital of Changde
Changde, Hunan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
The Second People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jilin Province People's Hospital
Changchun, Jilin, China
Yanbian University Hospital (Yanbian Hospital)
Yanji, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Jining No 1 People's Hospital
Jining, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Yantaishan Hospital
Yantai, Shandong, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Deyang People's Hospital
Deyang, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Dongyang People's Hospital
Dongyang, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Huzhou Third Municipal Hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Ningbo Medical Center (Lihuili Hospital)
Ningbo, Zhejiang, China
The First People's Hospital of Wenling
Wenling, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The People's Hospital of Wenzhou
Wenzhou, Zhejiang, China
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2022
First Posted
January 6, 2023
Study Start
April 6, 2023
Primary Completion
October 29, 2024
Study Completion
May 6, 2025
Last Updated
October 1, 2025
Record last verified: 2025-06