This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).
This study is a randomized, double-blind, placebo-controlled Phase II study in participants with moderate-to-severe Sjögren's disease. Eligible participants will be randomized to receive IBI355 or placebo during the double-blind treatment period. The study will evaluate the efficacy of IBI355 in reducing systemic disease activity and improving patient-reported symptoms and disease-related functional outcomes. Safety and tolerability will be assessed throughout the study. Pharmacokinetic, immunogenicity, pharmacodynamic, and other relevant clinical assessments will also be performed as specified in the protocol. The results of this study are intended to characterize the efficacy and safety profile of IBI355 in participants with Sjögren's disease and to support its further clinical development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
198
Matching placebo of IBI355， IV ，corresponding dose regimen according to study design
Telitacicept 160 mg SC QW × 24 doses (Weeks 0-24).
Matching placebo of Talitacicept ，SC QW × 24 doses.
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Time frame: Baseline and Week 24
Change from Baseline in ESSDAI Score at Weeks 12 and 48
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Time frame: Baseline to Weeks 12 and 48
Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported measure assessing dryness, fatigue, and pain. Each domain is rated on a 0-to-10 numerical rating scale, and the total ESSPRI score is calculated as the mean of the three domain scores, ranging from 0 to 10. Higher scores indicate greater symptom severity. A decrease from baseline indicates improvement.
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48
Stimulated salivary flow rate will be measured according to the protocol-specified procedure. An increase from baseline indicates an improvement in stimulated salivary gland function.
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in Schirmer Test at Week 48
The Schirmer test is used to assess tear production and is reported as the length of wetting of the test strip over 5 minutes, measured in millimeters (mm/5 min). Higher values indicate greater tear production.
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IBI355,IV,corresponding dose regimen according to study design
Time frame: Baseline to Week 48
Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48
The Sj?gren's Tool for Assessing Response (STAR) is a composite assessment of treatment response in Sj?gren's disease incorporating systemic disease activity, patient-reported symptoms, and biological and glandular domains. Higher scores indicate a greater treatment response.
Time frame: Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48
The FACIT-Fatigue scale is a 13-item patient-reported measure of fatigue. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. An increase from baseline indicates improvement.
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score at Weeks 12, 24, and 48
The EQ-5D-5L is a standardized measure of health status assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity. Responses are converted to an EQ-5D-5L index score using the prespecified value set, with higher index scores indicating better health status.
Time frame: Baseline to Weeks 12, 24, and 48
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed throughout the study.
Time frame: From the first dose of study intervention through Week 48