A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 52
- 主要终点
- Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
研究概览
简要总结
The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).
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
- •Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification
- •Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) ≥ 5
- •Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB)
排除标准
- •Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Lanraplenib
Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
干预措施: Lanraplenib (Drug)
Lanraplenib
Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
干预措施: Filgotinib placebo (Drug)
Lanraplenib
Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
干预措施: Tirabrutinib placebo (Drug)
Filgotinib
Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
干预措施: Filgotinib (Drug)
Filgotinib
Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
干预措施: Lanraplenib placebo (Drug)
Filgotinib
Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
干预措施: Tirabrutinib placebo (Drug)
Tirabrutinib
Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
干预措施: Tirabrutinib (Drug)
Tirabrutinib
Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
干预措施: Lanraplenib placebo (Drug)
Tirabrutinib
Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
干预措施: Filgotinib placebo (Drug)
Placebo, then active treatment
Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
- filgotinib + lanraplenib placebo + tirabrutinib placebo
- lanraplenib + filgotinib placebo + tirabrutinib placebo
- tirabrutinib + filgotinib placebo + lanraplenib placebo
干预措施: Lanraplenib (Drug)
Placebo, then active treatment
Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
- filgotinib + lanraplenib placebo + tirabrutinib placebo
- lanraplenib + filgotinib placebo + tirabrutinib placebo
- tirabrutinib + filgotinib placebo + lanraplenib placebo
干预措施: Filgotinib (Drug)
Placebo, then active treatment
Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
- filgotinib + lanraplenib placebo + tirabrutinib placebo
- lanraplenib + filgotinib placebo + tirabrutinib placebo
- tirabrutinib + filgotinib placebo + lanraplenib placebo
干预措施: Tirabrutinib (Drug)
Placebo, then active treatment
Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
- filgotinib + lanraplenib placebo + tirabrutinib placebo
- lanraplenib + filgotinib placebo + tirabrutinib placebo
- tirabrutinib + filgotinib placebo + lanraplenib placebo
干预措施: Lanraplenib placebo (Drug)
Placebo, then active treatment
Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
- filgotinib + lanraplenib placebo + tirabrutinib placebo
- lanraplenib + filgotinib placebo + tirabrutinib placebo
- tirabrutinib + filgotinib placebo + lanraplenib placebo
干预措施: Filgotinib placebo (Drug)
Placebo, then active treatment
Filgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
- filgotinib + lanraplenib placebo + tirabrutinib placebo
- lanraplenib + filgotinib placebo + tirabrutinib placebo
- tirabrutinib + filgotinib placebo + lanraplenib placebo
干预措施: Tirabrutinib placebo (Drug)
结局指标
主要结局
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
时间窗: Week 12
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
次要结局
- Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12(Baseline; Week 12)
- Change From Baseline in ESSPRI at Week 24(Baseline; Week 24)
- Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12(Baseline; Week 12)
- Change From Baseline in ESSDAI at Week 24(Baseline; Week 24)