Clinical Trials in China / NCT07375524
Starting soon
Phase 2
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome
NCT07375524 · tracked via the Priya Life Science China tracker
Condition(s) studied
Primary Sjögren Syndrome
Investigational drug(s) / intervention(s)
ESG206: ESG206 Low Dose administered by intravenous infusion
ESG206: ESG206 High Dose administered by intravenous infusion
Placebo: Placebo administered by intravenous infusion
Study summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with primary Sjögren's syndrome.
Eligibility
Inclusion Criteria:
* Adults (≥18 years of age) with a confirmed diagnosis of primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
* Evidence of active disease at screening
* Willing and able to provide written informed consent
Exclusion Criteria:
* Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases
* Prior or recent use of prohibited immunomodulatory therapies
* Clinically significant infections, malignancies, or uncontrolled medical conditions
* Pregnancy or breastfeeding
Primary outcome measure(s)
- Change from baseline in ESSDAI score compared with placebo. — Up to approximately 25 weeks
ESSDAI is a validated clinical disease activity index for Sjögren's syndrome. It includes 12 organ-specific domains, each scored by the investigator according to severity using 3- or 4-level scales. Weighted domain scores are summed to generate a total score (maximum score: 123). Domains include constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, and biological domains. Higher scores on the ESSDAI scale are associated with poorer health states.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Peking University Shougang Hospital | Beijing | Beijing Municipality | |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | |
| The Second Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | |
| Hebei Petro China Central Hospital | Langfang | Hebei | |
| Changde First People's Hospital | Changde | Hunan | |
| Xiangya Hospital of Central South University | Changsha | Hunan | |
| Zhuzhou Central Hospital | Zhuzhou | Hunan | |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | |
| the Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | |
| Qilu Hospital of Shandong University | Jinan | Shandong | |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | |
| Zaozhuang Municipal Hospital | Zaozhuang | Shandong | |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | |
| Huzhou Third People's Hospital | Huzhou | Zhejiang | |
| Jinhua Municipal Central Hospital | Jinhua | Zhejiang | |
| Wenzhou People's Hospital | Wenzhou | Zhejiang |
More Shanghai Escugen Biotechnology Co., Ltd trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07375524 on ClinicalTrials.gov ↗ ← All trials in China