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

Primary Sjögren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078386
• Other study ID #: 18C012
• Status: Completed
• Phase: Phase 2
• Start date: November 21, 2019
• Est. completion date: October 26, 2021

Study information

• Verified date: January 2022
• Source: RemeGen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 26, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Remegen,Ltd.	Yantai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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