Status:
COMPLETED
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Primary Sjögren's Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04078386
Start Date
November 21 2019
End Date
October 26 2021
Last Update
January 11 2022
Active Locations (1)
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1
Remegen,Ltd.
Yantai, Shandong, China, 264006