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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESG206 Low Dose | Active Comparator | ESG206 Low Dose Injection administered by intravenous infusion |
|
| ESG206 High Dose | Active Comparator | ESG206 High Dose Injection administered by intravenous infusion |
|
| Placebo | Placebo Comparator | Placebo Injection administered by intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESG206 | Drug | ESG206 Low Dose administered by intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ESSDAI score compared with placebo. | 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. | Up to approximately 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Zhou, PhD | Contact | 86 21 5855 6098 | zhaoyonggang@escugen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Peking University Shougang Hospital |
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| ESG206 |
| Drug |
ESG206 High Dose administered by intravenous infusion |
|
| Placebo | Drug | Placebo administered by intravenous infusion |
|
| Beijing |
| Beijing Municipality |
| China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| The Second Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China |
| Hebei Petro China Central Hospital | Langfang | Hebei | China |
| Changde First People's Hospital | Changde | Hunan | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Zhuzhou Central Hospital | Zhuzhou | Hunan | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
| the Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Affiliated Hospital of Jining Medical University | Jining | Shandong | China |
| Zaozhuang Municipal Hospital | Zaozhuang | Shandong | China |
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
|
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Huzhou Third People's Hospital | Huzhou | Zhejiang | China |
| Jinhua Municipal Central Hospital | Jinhua | Zhejiang | China |
| Wenzhou People's Hospital | Wenzhou | Zhejiang | China |