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Primary Sjogren's SyndromePhase 3NCT05673993

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

A Phase 3 study testing Telitacicept 80 mg and Telitacicept 160 mg in people with Primary Sjogren's Syndrome, run by RemeGen Co., Ltd. at 78 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Primary Sjogren's Syndrome
What is being tested?
Telitacicept 80 mg and Telitacicept 160 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
78 sitesChina
Study dates
6 Apr 2023to 6 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

China78 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Binzhou Medical University Hospital

    Binzhou, Shandong

  • Jilin Province People's Hospital

    Changchun, Jilin

  • The First People's Hospital of Changde

    Changde, Hunan

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Second People's Hospital of Changzhou

    Changzhou, Jiangsu

  • West China Hospital Sichuan University

    Chengdu, Sichuan

  • The First People's Hospital of Chenzhou

    Chenzhou, Hunan

  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality

  • Deyang People's Hospital

    Deyang, Sichuan

  • Dongyang People's Hospital

    Dongyang, Zhejiang

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Guilin People's Hospital

    Guilin, Guangxi

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Huzhou Third Municipal Hospital

    Huzhou, Zhejiang

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang

  • Jining No 1 People's Hospital

    Jining, Shandong

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • Hebei PetroChina Central Hospital

    Langfang, Hebei

  • Liuzhou Workers' Hospital

    Liuzhou, Guangxi

  • Meizhou People's Hospital

    Meizhou, Guangdong

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Ningbo Medical Center (Lihuili Hospital)

    Ningbo, Zhejiang

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shanghai Ninth People's Hopital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • South China Hospital of Shenzhen University

    Shenzhen, Guangdong

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang

  • The First People's Hospital of Wenling

    Wenling, Zhejiang

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • The People's Hospital of Wenzhou

    Wenzhou, Zhejiang

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Yanbian University Hospital (Yanbian Hospital)

    Yanji, Jilin

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • Yantaishan Hospital

    Yantai, Shandong

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

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

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.

Read the detailed description

This is a phase Ⅲ, multi-center, randomized, double-blind, 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.

Being tested
Telitacicept 80 mg, Telitacicept 160 mg, Placebo
Keywords
primary Sjogren's Syndrome, pSS, RC18

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telitacicept 80 mgBiological

    Also called RC 18 80 mg

    Telitacicept 80 mg subcutaneously once a week.

  • Telitacicept 160 mgBiological

    Also called RC 18 160 mg

    Telitacicept 160 mg subcutaneously once a week.

  • PlaceboDrug

    Subjects will be given subcutaneous placebo once a week.

Study groups in NCT05673993
Study groupRoleWhat they receive
Telitacicept 80 mgExperimentalSubjects will be given subcutaneous Telitacicept 80 mg once a week for 48 weeks.
Receives: Biological: Telitacicept 80 mg
Telitacicept 160 mgExperimentalSubjects will be given subcutaneous Telitacicept 160 mg once a week for 48 weeks.
Receives: Biological: Telitacicept 160 mg
PlaceboPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (6)

  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.

    Measured: Week 48

  2. 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

    Measured: Week 24 & Week 48

  3. 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.

    Measured: Week 24 & Week 48

  4. 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.

    Measured: Week 24 & Week 48

  5. 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).

    Measured: Week 24 & Week 48

  6. 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.

    Measured: Up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2023
  2. Study start6 Apr 2023
  3. Primary completion29 Oct 2024
  4. Study completion6 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673993
Sponsor's protocol ID
18C022
Status last verified
Jun 2025
First submitted
29 Dec 2022
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telitacicept 80 mg and Telitacicept 160 mg in people with Primary Sjogren's Syndrome, run by RemeGen Co., Ltd. at 78 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in ESSDAI score (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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