A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shanghai Escugen Biotechnology Co., Ltd
- Enrollment
- 40
- Locations
- 21
- Primary Endpoint
- Change from baseline in ESSDAI score compared with placebo.
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ESG206 Low Dose
ESG206 Low Dose Injection administered by intravenous infusion
Intervention: ESG206 (Drug)
ESG206 High Dose
ESG206 High Dose Injection administered by intravenous infusion
Intervention: ESG206 (Drug)
Placebo
Placebo Injection administered by intravenous infusion
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in ESSDAI score compared with placebo.
Time Frame: Up to approximately 25 weeks
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.
Secondary Outcomes
No secondary outcomes reported