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

Primary Sjogren's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673993
• Other study ID #: 18C022
• Status: Recruiting
• Phase: Phase 3
• Start date: April 7, 2023
• Est. completion date: June 2028

Study information

• Verified date: October 2023
• Source: RemeGen Co., Ltd.
• Contact: Binghua Xiao
• Phone: 86-010-58076833
• Email: binghua.xiao[@]remegen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: June 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Sjogren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Biological:
• Telitacicept 80 mg
Telitacicept 80 mg subcutaneously once a week.
• Telitacicept 160 mg
Telitacicept 160 mg subcutaneously once a week.

Drug:
• Placebo
Subjects will be given subcutaneous placebo once a week.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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