A Randomized, Blinded, Placebo-Controlled, Phase 2a, Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants With Cutaneous Lupus Erythematosus (CLE)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 17
- 主要终点
- Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
研究概览
简要总结
The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.
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, Care Provider)
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
- •Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time.
- •Must have active CLE at screening and Day
- •Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
- •Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day
- •Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.
- •Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points.
- •Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.
- •Topical corticosteroids or topical calcineurin inhibitors.
- •Oral corticosteroids.
- •Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
- •Individuals willing to comply with all study visits and assessments.
排除标准
- •Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day
- •Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
- •Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus).
- •Meet protocol-specified infection or lab criteria.
- •Any active infection that is clinically significant (per investigator judgment).
- •Any history of clinically significant liver disease.
- •Significant cardiovascular disease.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Edecesertib
Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.
干预措施: Edecesertib (Drug)
Edecesertib Placebo
Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.
干预措施: Edecesertib Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
时间窗: Baseline, Week 12
The CLASI is a standardized, validated measure of cutaneous lupus disease activity and damage, widely used in clinical trials. CLASI consists of CLASI - activity (A) and - damage (D) measurements. CLASI-A scores range from 0 to 70, with higher scores indicating more severe disease activity.
次要结局
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(First dose date up to 12 weeks plus 30 days)
- Percentage of Participants Experiencing Laboratory Abnormalities(First dose date up to 12 weeks plus 30 days)
- Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12(Week 12)
- Percentage of Participants Experiencing Serious Treatment-emergent Adverse Events (TESAEs)(First dose date up to 12 weeks plus 30 days)
- Plasma Concentration of Edecesertib(Postdose at Week 2, Predose at Week 4 and 12, and Week 8 (anytime of the day))