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)

ESG206ESG206Placebo

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

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)

Facility	City	Region
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

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A Study of CAR-T Cells in Subjects With 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