A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.

Study Overview

• Status: Completed
• Conditions: Primary Sjögren's Syndrome
• Intervention / Treatment: Biological: RC18 240 mg; Biological: RC18 160 mg; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Chengdu, China
    • West China School of Medicine，West China Hospital of Sichuan University
  • Guangzhou, China
    • The second Affiliated Hospital of Guangzhou Medical University
  • Shanghai, China
    • Renji Hospital, Shanghai Jiao Tong University School of Medicine
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Xiamen, China
    • The First Affiliated Hospital of Xiamen University
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical University
    • Hefei, Anhui, China
      • The First Affiliated Hospital of USTC，Anhui Provincial Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital Of Central South University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
    • Pingxiang, Jiangxi, China
      • Pingxiang People's Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • The First Hospital of Shanxi Medical University
  • Zhejiang
    • Huzhou, Zhejiang, China
      • Huzhou Third Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntarily signed informed consent ;
• Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
• Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies
• ESSDAI score ≥ 5.

Exclusion Criteria:

• Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases;
• Abnormal laboratory parameters need to be excluded, including but not limited to:
• Immunosuppressive agents were used within 4 weeks prior to randomization.;
• The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks;
• Use of biological agents for targeted therapy in the first 6 months of randomization;
• Treatment of primary Sjogren's syndrome with traditional Chinese medicine and proprietary Chinese medicine within 4 weeks before randomization;
• The use of saliva-stimulating drugs within 7 days prior to randomization;
• Sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks;
• Intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization;
• Infection with herpes zoster or HIV and hepatitis C virus(HCV) antibody positive;
• Currently suffering from active hepatitis or severe liver lesions and history;
• Malignant tumor patients ;
• Combined with involvement of important organs or neuropathy;
• Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the shorter).
• Pregnant , lactating women and men or women who have birth plans during the research;
• Investigator considers candidates not appropriating for the study

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
Placebo Comparator: Placebo	Biological: Placebo; Patients received the test group Placebo weekly administered subcutaneously for 24 times.
Experimental: RC18 240mg	Biological: RC18 240 mg; Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Experimental: RC18 160 mg	Biological: RC18 160 mg; Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.	ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes 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.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of change of ESSDAI score compared to the baseline at week 12.	ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes 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.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.	week 12
The amount of change of European League Against Rheumatism Sjögren'sSyndrome Patient Reported Index(ESSPRI) score compared to the baseline at week 12 and week 24	European League Against Rheumatism Sjögren's Syndrome Patient Reported Index.Dryness, pain, somatic and mental fatigue were identified as the main symptoms of patients with primary SS. It was suspected that a single 0-10 numerical scale for each domain was sufficient to assess these symptoms.The higher values represent a worse outcome.Subscales are combined by averaged.	week 12，24
Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24	The measurement tool is Visual Analogue Scale/Score（VAS）.The doctor assesses participant's disease activity on a VAS of 0 - 100 mm on the questionnaire form.	week 12,24
Overall patient assessment of disease activity compared to baseline at week 12 and week 24	The measurement tool is Visual Analogue Scale/Score（VAS）. The participant assesses his/her own disease activity on a VAS of 0 - 100 mm on the questionnaire form.	week 12,24
Changes in short form(SF)-36 relative to baseline at week 12 and week 24	SF-36=36-item short form. As a concise health questionnaire, SF-36 summarized the quality of life of the subjects from eight aspects: physiological function, physical pain, general health condition, energy, social function, emotional function and mental health.The SF-361 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales. An additional item measures health transition.The higher values represent a better outcome.Subscales are combined by averaged.	week 12,24
Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24	Multidimensional Fatigue Inventory.The MFI is a 20-item scale designed to evaluate fi ve dimensions of fatigue: general fatigue, physical fatigue, reduced motivation,reduced activity, and mental fatigue.The higher values represent a worse outcome,Subscales are combined by summed.	week 12,24

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.

Publications and helpful links

General Publications

• Xu D, Fang J, Zhang S, Huang C, Huang C, Qin L, Li X, Chen M, Liu X, Liu Y, Li Z, Hu J, Bao C, Wei W, Tian J, Duan X, Zeng X. Efficacy and safety of telitacicept in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial. Rheumatology (Oxford). 2024 Mar 1;63(3):698-705. doi: 10.1093/rheumatology/kead265.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2019
• Primary Completion (Actual): June 23, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• 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; RC-18
• Other Study ID Numbers: 18C012

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