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

Sponsor

RemeGen Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05673993

Collaborator

(none)

375

Enrollment

Locations

Arms

Anticipated Duration (Months)

5.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Sjogren's Syndrome	Biological: Telitacicept 80 mg Biological: Telitacicept 160 mg Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in ESSDAI score [Week 24]
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 [Week 48]
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 [Week 24 & Week 48]
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 [Week 24 & Week 48]
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% [Week 24 & Week 48]
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 [Week 24 & Week 48]
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 [Up to Week 48]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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);

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China
2	Anhui Provincial Hospital	Hefei	Anhui	China
3	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui	China
4	Beijing Hospital	Beijing	Beijing	China
5	Peking Union Medical College Hospital	Beijing	Beijing	China
6	Peking University Shougang Hospital	Beijing	Beijing	China
7	The First Hospital Affiliated to the Army Medical University	Chongqing	Chongqing	China
8	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China
9	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China
10	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong	China
11	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
12	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong	China
13	Shenzhen People's Hospital	Shenzhen	Guangdong	China
14	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi	China
15	Guilin People's Hospital	Guilin	Guangxi	China
16	Liuzhou Workers' Hospital	Liuzhou	Guangxi	China
17	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China
18	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China
19	The Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou	China
20	Affiliated Hospital of Hebei University	Baoding	Hebei	China
21	The Second Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
22	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China
23	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
24	The First People's Hospital of Changde	Changde	Hunan	China
25	Hunan Provincial People's Hospital	Changsha	Hunan	China
26	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China
27	Xiangya Hospital of Central South University	Changsha	Hunan	China
28	The First People's Hospital of Chenzhou	Chenzhou	Hunan	China
29	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia	China
30	The Second People's Hospital of Changzhou	Changzhou	Jiangsu	China
31	Jiangsu Province Hospital	Nanjing	Jiangsu	China
32	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China
33	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi	China
34	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi	China
35	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
36	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
37	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi	China
38	Jilin Province People's Hospital	Changchun	Jilin	China
39	Yanbian University Hospital (Yanbian Hospital)	Yanji	Jilin	China
40	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China
41	The First Hospital of China Medical University	Shenyang	Liaoning	China
42	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China
43	Qilu Hospital of Shandong University	Jinan	Shandong	China
44	Shandong Provincial Hospital	Jinan	Shandong	China
45	Jining No 1 People's Hospital	Jining	Shandong	China
46	Yantai Yuhuangding Hospital	Yantai	Shandong	China
47	Yantaishan Hospital	Yantai	Shandong	China
48	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China
49	Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China
50	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China
51	Shanxi Bethune Hospital	Taiyuan	Shanxi	China
52	Shanxi Provincial People's Hospital	Taiyuan	Shanxi	China
53	West China Hospital Sichuan University	Chengdu	Sichuan	China
54	Mianyang Central Hospital	Mianyang	Sichuan	China
55	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan	China
56	Tianjin Medical University General Hospital	Tianjin	Tianjin	China
57	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang	China
58	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China
59	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China
60	The First People's Hospital of Yunnan Province	Kunming	Yunnan	China
61	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
62	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China
63	Huzhou Third Municipal Hospital	Huzhou	Zhejiang	China
64	The Second Hospital of Jiaxing	Jiaxing	Zhejiang	China
65	Jinhua Municipal Central Hospital	Jinhua	Zhejiang	China
66	Ningbo Medical Center (Lihuili Hospital)	Ningbo	Zhejiang	China
67	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China
68	The People's Hospital of Wenzhou	Wenzhou	Zhejiang	China

Sponsors and Collaborators

RemeGen Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RemeGen Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05673993

Other Study ID Numbers:

18C022

First Posted:

Jan 6, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by RemeGen Co., Ltd.

primary Sjogren's Syndrome

pSS

RC18

Additional relevant MeSH terms:

Sjogren's Syndrome

Syndrome

Study Results

No Results Posted as of Jan 9, 2023