primary Sjögren’s syndrome
Conditions
Interventions
Subcutaneous treatment group:Subcutaneous injection of telitacicept
placebo group:conventional anti-dryness therapy
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. The patient has voluntarily signed the informed consent form. 2. Age 18–55 years, either sex. 3. Meets the 2016 ACR/EULAR classification criteria for primary Sjögren’s syndrome. 4. Disease duration = 5. 8. Unstimulated whole salivary flow (UWS) > 0.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with secondary Sjögren’s syndrome, i.e., secondary to other autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis. 2. Investigator-assessed severe systemic involvement of Sjögren’s syndrome, including but not limited to: a) Severe vasculitis affecting the kidneys, gastrointestinal tract, heart, lungs, or central nervous system (cutaneous vasculitis excluded); b) Active central or peripheral nervous-system involvement requiring high-dose glucocorticoid therapy; c) Severe renal involvement defined as GFR 2 mg/dL, or proteinuria > 3 g/day; d) Severe pulmonary involvement defined as dyspnea at rest or pulmonary-function tests showing FVC 2 × ULN, total bilirubin > 2 × ULN, ALT > 3 × ULN, AST > 3 × ULN, alkaline phosphatase > 2 × ULN, CK > 5 × ULN. 4. Use of any biologic targeted therapy within 6 months prior to enrollment (e.g., rituximab, belimumab, abatacept, anakinra, etanercept, infliximab, etc.). 5. Use of sialagogues such as anethole trithione or pilocarpine within 7 days prior to enrollment. 6. Active herpes zoster, positive anti-HCV, positive anti-HIV, or active tuberculosis during screening. 7. Active hepatitis or history/evidence of severe hepatic disease. Per hepatitis B serology: • HBsAg-positive subjects must be excluded; • HBsAg-negative / HBcAb-positive subjects (regardless of HBsAb status) must have HBV-DNA testing: if HBV-DNA positive, exclude; if HBV-DNA negative, inclusion permitted. 8. Malignancy of any type. 9. Participation in any other clinical trial within 28 days or within 5 half-lives of the investigational drug (whichever is shorter) before enrollment. 10. Pregnant or breastfeeding women, or subjects planning pregnancy during the study. 11. Any patient considered by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in the change from baseline in ESSDAI score at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group differences at Week 24 in: STAR response rate ?change from baseline in ESSPRI score ? labial salivary-gland histopathology ?focus score ? focus area;Change from baseline at Week 24 in MFI-20, SF-36, anxiety, depression, obsessive-compulsive, cognitive, suicidality scales, and Pittsburgh Sleep Quality Index scores.; | — |
Countries
China
Contacts
Public ContactXu Jian
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed