A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤75 years.
- •Diagnosis of Sjögren's syndrome per 2016 ACR/EULAR classification criteria.
- •Duration of Sjögren's syndrome diagnosis ≤7.5 years.
- •Serum anti-Ro/SSA (Ro60 and/or Ro52) positive.
- •Stimulated whole saliva flow rate ≥0.05 mL/min at screening.
- •Baseline ESSDAI score ≥5 in ≥1 of the following domains: systemic, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic, biological.
- •Stable background therapy (hydroxychloroquine ≤400 mg/day, methotrexate ≤25 mg/week, or azathioprine ≤150 mg/day) for ≥12 weeks with stable dose ≥8 weeks prior to randomization.
- •Stable oral corticosteroid dose (≤10 mg/day prednisone equivalent) for ≥4 weeks prior to randomization.
排除标准
- •Known hypersensitivity to IBI355 or its excipients.
- •Pregnancy or breastfeeding.
- •Uncontrolled interstitial lung disease (ILD) associated with Sjögren's syndrome (e.g., FVC <70% predicted, ClinESSDAI pulmonary domain indicating severe activity, or NYHA Class III/IV dyspnea).
- •Active or untreated latent tuberculosis (IGRA-positive without ≥1 month prophylactic treatment).
- •Chronic hepatitis B (HBsAg+), hepatitis C (HCV RNA+), HIV, or syphilis.
- •Prior use of rituximab, other anti-CD20 agents, or other biologics targeting CD40/CD40L, BAFF/APRIL, or CTLA-4 within 6 months prior to randomization.
- •Use of JAK/TYK inhibitors within 8 weeks prior to randomization.
研究组 & 干预措施
Part B: Placebo group (Telitacicept-matched)
Participants received matching placebo SC QW from Week 0 to Week 24. Follow-up through Week 36.
干预措施: PartB -Placebo for Telitacicept (Drug)
Part A: IBI355 group
IBI355，IV,corresponding dose regimen according to study cohort( Part A) .
干预措施: Part A - Placebo for IBI355 (Drug)
Part A: IBI355 group
IBI355，IV,corresponding dose regimen according to study cohort( Part A) .
干预措施: Part A - IBI355 (Drug)
Part B: Telitacicept 160 mg group
Participants received telitacicept 160 mg SC QW from Week 0 to Week 24. Follow-up through Week 36
干预措施: Part B -Telitacicept (Drug)
Part A: Placebo group（IBI355-matched）
Matching placebo of IBI355， IV ，corresponding dose regimen according to study design
干预措施: Part A - Placebo for IBI355 (Drug)
Part A: Placebo group（IBI355-matched）
Matching placebo of IBI355， IV ，corresponding dose regimen according to study design
干预措施: Part A - IBI355 (Drug)
结局指标
主要结局
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
时间窗: Baseline and 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.
次要结局
- Change from Baseline in ESSDAI Score at Weeks 12 and 48(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(Baseline to Weeks 12, 24, and 48)
- Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48(Baseline to Weeks 12, 24, and 48)
- Change from Baseline in Schirmer Test at Week 48(Baseline to Week 48)
- Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48(Baseline to Week 48)
- Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48(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(Baseline to Weeks 12, 24, and 48)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the first dose of study intervention through Week 48)