A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 16
- 主要终点
- Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following:
- •Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index [CLASI] activity score ≥ 10) at screening and Day 1
- •Prior intolerance or inadequate response to at least one of the listed medications for the treatment of CLE
- •Stable dose (defined as no change in prescription for at least 28 days prior to Day 1) of antimalarials and/or topical or oral corticosteroids is permitted during the study. Individuals who are not planning to continue these medications during the study must have discontinued them at least 28 days prior to Day 1
排除标准
- •Use of prohibited concomitant medications per study protocol
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Lanraplenib 30 mg
Lanraplenib + filgotinib placebo for 48 weeks
干预措施: Lanraplenib (Drug)
Lanraplenib 30 mg
Lanraplenib + filgotinib placebo for 48 weeks
干预措施: Filgotinib placebo (Drug)
Filgotinib 200 mg
Filgotinib + lanraplenib placebo for 48 weeks
干预措施: Filgotinib (Drug)
Filgotinib 200 mg
Filgotinib + lanraplenib placebo for 48 weeks
干预措施: Lanraplenib placebo (Drug)
Placebo
Filgotinib placebo + lanraplenib placebo for 12 weeks
干预措施: Lanraplenib placebo (Drug)
Placebo
Filgotinib placebo + lanraplenib placebo for 12 weeks
干预措施: Filgotinib placebo (Drug)
Placebo to Lanraplenib 30 mg
After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.
干预措施: Lanraplenib (Drug)
Placebo to Lanraplenib 30 mg
After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.
干预措施: Filgotinib placebo (Drug)
Placebo to Filgotinib 200 mg
After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.
干预措施: Filgotinib (Drug)
Placebo to Filgotinib 200 mg
After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.
干预措施: Lanraplenib placebo (Drug)
结局指标
主要结局
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
时间窗: Baseline; Week 12
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
次要结局
- Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline(Baseline; Week 12)
- Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline(Baseline; Week 12)
- Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline(Baseline; Week 24)
- Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline(Baseline; Week 24)