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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ESG206

    Drug

    Anti-BAFF-R Monoclonal Antibody

  • ESG206

    Drug

    Anti-BAFF-R Monoclonal Antibody

  • Placebo

    Drug

    Placebo

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: ESG206 High DoseExperimental treatment 1 intervention
Group B: ESG206 Low DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to approximately 25 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Escugen Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: