Health Trials

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

ConditionSystemic Lupus Erythematosus (SLE)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Escugen Biotechnology Co., Ltd

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ESG206
  • ESG206
  • Placebo

Treatment groups

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Shanghai Escugen Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov