A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome

Shanghai Escugen Biotechnology

Status and phase: Begins enrollment this month; Phase 2

Conditions: Primary Sjögren Syndrome

Treatments: Drug: ESG206; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07375524

ESG206-PSS-01

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with primary Sjögren's syndrome.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years of age) with a confirmed diagnosis of primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
• Evidence of active disease at screening
• Willing and able to provide written informed consent

Exclusion criteria

• Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases
• Prior or recent use of prohibited immunomodulatory therapies
• Clinically significant infections, malignancies, or uncontrolled medical conditions
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups, including a placebo group

ESG206 Low Dose

Active Comparator group

Description:

ESG206 Low Dose Injection administered by intravenous infusion

Treatment:

Drug: ESG206

Drug: ESG206

ESG206 High Dose

Active Comparator group

Description:

ESG206 High Dose Injection administered by intravenous infusion

Treatment:

Drug: ESG206

Drug: ESG206

Placebo

Placebo Comparator group

Description:

Placebo Injection administered by intravenous infusion

Treatment:

Drug: Placebo