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Clinical Trials in China / NCT07760155
Starting soon Phase 2

A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus

NCT07760155 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Escugen Biotechnology Co., Ltd
Phase
Phase 2
Started
2026-09-01
Last updated
2026-08-12

Condition(s) studied

Systemic Lupus Erythematosus (SLE)

Investigational drug(s) / intervention(s)

ESG206 →ESG206 →Placebo

ESG206: Anti-BAFF-R Monoclonal Antibody

ESG206: Anti-BAFF-R Monoclonal Antibody

Placebo: Placebo

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 Systemic Lupus Erythematosus (SLE).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Adults (≥18 years of age) with a confirmed diagnosis of Systemic Lupus Erythematosus * Evidence of active disease at screening * Willing and able to provide written informed consent Exclusion Criteria: * Have other autoimmune diseases that may interfere with the assessment of SLE * Prior or recent use of prohibited immunomodulatory therapies * Clinically significant infections, malignancies, or uncontrolled medical conditions * Pregnancy or breastfeeding

Primary outcome measure(s)

  • SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo — Up to approximately 25 weeks

Trial sites (20)

FacilityCityRegionStatus
Shenzhen Third People's Hospital Shenzhen Guangdong
Zhongshan Traditional Chinese Medicine Hospital Zhongshan Guangdong
Second Affiliated Hospital of Guilin Medical University Guilin Guangxi
Liupanshui Shougang Shuigang Hospital Liupanshui Guizhou
Affiliated Hospital of Hebei Engineering University Handan Hebei
Second Hospital of Hebei Medical University Shijiazhuang Hebei
Changde First People's Hospital Changde Hunan
Xiangya Hospital, Central South University Changsha Hunan
Loudi Central Hospital Loudi Hunan
Zhuzhou Central Hospital Zhuzhou Hunan
Xuzhou Central Hospital Xuzhou Jiangsu
Zibo Central Hospital Zibo Shandong
Renji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Shanghai Tongji Hospital Shanghai Shanghai Municipality
Linfen Central Hospital Linfen Shanxi
Mianyang Central Hospital Mianyang Sichuan
Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan
Huzhou Third People's Hospital Huzhou Zhejiang
Jinhua Municipal Central Hospital Jinhua Zhejiang
Ningbo Medical Center Lihuili Hospital Ningbo Zhejiang

More Shanghai Escugen Biotechnology Co., Ltd trials in China

A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia Recruiting
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome Starting soon
Study of ESG406 in Adults With Solid Tumors Recruiting

Other trials for the same condition

YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases Starting soon
Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells Recruiting
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases Recruiting
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases Enrolling by invitation
An Open-label Study of GB261 in Refractory Seropositive Systemic Lupus Erythematosus Starting soon
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 NCT07760155 on ClinicalTrials.gov ↗ ← All trials in China