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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Sjogren's Syndrome
• Intervention / Treatment: Biological: Telitacicept 80 mg; Biological: Telitacicept 160 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Binghua Xiao; Phone Number: 86-010-58076833; Email: binghua.xiao@remegen.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincial Hospital
    • Wuhu, Anhui, China
      • Recruiting
      • The first affiliated hospital of Wannan Medical College
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Shougang Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Tongren Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital of Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Recruiting
      • The First Hospital Affiliated to the Army Medical University
  • Fujian
    • Quanzhou, Fujian, China
      • Recruiting
      • The Second Affiliated Hospital of Fujian Medical University
    • Xiamen, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen Memorial Hospital
    • Meizhou, Guangdong, China
      • Recruiting
      • Meizhou People's Hospital
    • Shenzhen, Guangdong, China
      • Recruiting
      • ShenZhen People's Hospital
    • Shenzhen, Guangdong, China
      • Recruiting
      • South China Hospital of Shenzhen University
    • Zhongshan, Guangdong, China
      • Recruiting
      • Zhongshan Hospital of Traditional Chinese Medicine
  • Guangxi
    • Guilin, Guangxi, China
      • Recruiting
      • Affiliated Hospital of Guilin Medical University
    • Guilin, Guangxi, China
      • Recruiting
      • Guilin People's Hospital
    • Guilin, Guangxi, China
      • Recruiting
      • The Second Affiliated Hospital of Guilin Medical University
    • Liuzhou, Guangxi, China
      • Recruiting
      • Liuzhou Workers' Hospital
    • Liuzhou, Guangxi, China
      • Recruiting
      • Liuzhou People's Hospital
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • The Affiliated Hospital of Guizhou Medical University
    • Zunyi, Guizhou, China
      • Recruiting
      • The Affiliated Hospital of Zunyi Medical University
  • Hebei
    • Baoding, Hebei, China
      • Recruiting
      • Affiliated Hospital of Hebei University
    • Langfang, Hebei, China
      • Recruiting
      • Hebei Petrochina Central Hospital
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Affiliated Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • Recruiting
      • People's Hospital of Zhengzhou
  • Hunan
    • Changde, Hunan, China
      • Recruiting
      • The First People's Hospital of Changde
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial People's Hospital
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
    • Chenzhou, Hunan, China
      • Recruiting
      • The First People's Hospital of Chenzhou
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Recruiting
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Recruiting
      • The Second People's Hospital of Changzhou
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Recruiting
      • First Affiliated Hospital of Gannan Medical University
    • Ganzhou, Jiangxi, China
      • Recruiting
      • Ganzhou People's Hospital
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital Of Nanchang University
    • Nanchang, Jiangxi, China
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • Recruiting
      • Jiangxi Provincial People's Hospital
    • Pingxiang, Jiangxi, China
      • Recruiting
      • Jiangxi Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • Jilin Province People's Hospital
    • Yanji, Jilin, China
      • Recruiting
      • Yanbian University Hospital (Yanbian Hospital)
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital of China Medical University
  • Ningxia
    • Yinchuan, Ningxia, China
      • Recruiting
      • General Hospital of Ningxia Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi'An JiaoTong University
  • Shandong
    • Binzhou, Shandong, China
      • Recruiting
      • Binzhou Medical University Hospital
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital Of Shandong University
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
    • Jining, Shandong, China
      • Recruiting
      • Jining No 1 People's Hospital
    • Qingdao, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University (Qingdao)
    • Yantai, Shandong, China
      • Recruiting
      • Yantai Yuhuangding Hospital
    • Yantai, Shandong, China
      • Recruiting
      • Yantaishan Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China
      • Recruiting
      • Second Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital Sichuan University
    • Deyang, Sichuan, China
      • Recruiting
      • Deyang People's Hospital
    • Mianyang, Sichuan, China
      • Recruiting
      • Mianyang Central Hospital
    • Nanchong, Sichuan, China
      • Recruiting
      • Affiliated Hospital of North Sichuan Medical College
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin People's Hospital
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin First Center Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Recruiting
      • The first affiliated hospital of Xinjiang medical university
    • Urumqi, Xinjiang, China
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • The First People's Hospital of Yunnan Province
    • Kunming, Yunnan, China
      • Recruiting
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Dongyang, Zhejiang, China
      • Recruiting
      • Dongyang People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
    • Huzhou, Zhejiang, China
      • Recruiting
      • Huzhou Third Municipal Hospital
    • Jiaxing, Zhejiang, China
      • Recruiting
      • The First Hospital of Jiaxing
    • Jiaxing, Zhejiang, China
      • Recruiting
      • The second Hospital of Jiaxing
    • Jinhua, Zhejiang, China
      • Recruiting
      • Jinhua municipal central hospital
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo First Hospital
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo Medical Center (Lihuili Hospital)
    • Wenling, Zhejiang, China
      • Recruiting
      • The First People's Hospital of Wenling
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The People's Hospital of Wenzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Written informed consent provided.
2. Males and females, 18-70 years of age.
3. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016).
4. Anti-SSA antibody tested positive at screening.
5. ESSDAI score ≥ 5 at screening.

Main Exclusion Criteria:

1. Secondary Sjogren's syndrome.
2. 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.
3. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening.
4. Received live vaccine within 28 days prior to randomization.
5. Active hepatitis or history of severe liver diseases.
6. HIV positive.
7. Patients with malignant tumors.
8. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer.
9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept 80 mg; Subjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.	Biological: Telitacicept 80 mg; Telitacicept 80 mg subcutaneously once a week.; Other Names: RC 18 80 mg
Experimental: Telitacicept 160 mg; Subjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.	Biological: Telitacicept 160 mg; Telitacicept 160 mg subcutaneously once a week.; Other Names: RC 18 160 mg
Placebo Comparator: Placebo; 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.	Drug: Placebo; Subjects will be given subcutaneous placebo once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 48
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	Week 24 & Week 48
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.	Week 24 & Week 48
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.	Week 24 & Week 48
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).	Week 24 & Week 48
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.	Up to Week 48

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: primary Sjogren's Syndrome; pSS; RC18
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: 18C022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No