Not yet recruiting NCT07375524
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ESG206, ESG206, Placebo.
- Who it may be relevant to
- Registry conditions: Primary Sjögren Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Drug ESG206
ESG206 Low Dose administered by intravenous infusion - Drug ESG206
ESG206 High Dose administered by intravenous infusion - Drug Placebo
Placebo administered by intravenous infusion
Primary outcome measures
- Change from baseline in ESSDAI score compared with placebo. [Time frame: Up to approximately 25 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 21 centers
- Beijing Friendship Hospital, Capital Medical University — Beijing
- Peking University Shougang Hospital — Beijing
- The First Affiliated Hospital of Xiamen University — Xiamen
- The Second Affiliated Hospital of Guilin Medical University — Guilin
- Hebei Petro China Central Hospital — Langfang
- Changde First People's Hospital — Changde
- Xiangya Hospital of Central South University — Changsha
- Zhuzhou Central Hospital — Zhuzhou
- … and 13 more centers
Identifiers
NCT: NCT07375524 · ESG206-PSS-01