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

RemeGen

Status and phase

Completed

Phase 2

Conditions

Primary Sjögren's Syndrome

Treatments

Biological: RC18 240 mg

Biological: RC18 160 mg

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04078386

18C012

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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