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

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

Official Title
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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

Conditions
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Primary Sjögren's Syndrome

Intervention / Treatment
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* Biological: Placebo
* Biological: RC18 240 mg
* Biological: RC18 160 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RC18 240mg<br> | Biological: RC18 240 mg<br>* Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.<br>|
| Experimental: RC18 160 mg<br> | Biological: RC18 160 mg<br>* Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Patients received the test group Placebo weekly administered subcutaneously for 24 times.<br>|

What is the study measuring?
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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 |