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

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).

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shenzhen Third People's Hospital, Shenzhen, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESG206

Drug

Anti-BAFF-R Monoclonal Antibody

Placebo

Drug

Placebo

Primary outcomes

SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo

Time frame: Up to approximately 25 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Qiuyue Shan Qiuyue shan

CONTACT

[email protected]

86 21 5855 6098

Sponsors and collaborators

Lead sponsor

Shanghai Escugen Biotechnology Co., Ltd

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 12, 2026
Registry last updated: Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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