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

Phase 2Not Yet RecruitingNCT07375524

Shanghai Escugen Biotechnology Co., Ltd40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Sjögren Syndrome

Interventions

ESG206DRUG

ESG206 Low Dose administered by intravenous infusion

ESG206DRUG

ESG206 High Dose administered by intravenous infusion

PlaceboDRUG

Placebo administered by intravenous infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Change from baseline in ESSDAI score compared with placebo.

ESSDAI is a validated clinical disease activity index for Sjögren's syndrome. It includes 12 organ-specific domains, each scored by the investigator according to severity using 3- or 4-level scales. Weighted domain scores are summed to generate a total score (maximum score: 123). Domains include constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, and biological domains. Higher scores on the ESSDAI scale are associated with poorer health states.

Time frame: Up to approximately 25 weeks

Central Contacts

Qing Zhou, PhD

CONTACT

86 21 5855 6098 zhaoyonggang@escugen.com

Data from ClinicalTrials.gov

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