A Randomized, Blinded, Placebo-Controlled, Phase 1b Study of GS-5718 in Subjects With Cutaneous Lupus Erythematosus (CLE)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus erythematosus (CLE) with or without systemic lupus erythematosus (SLE).
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
- •Either fulfill the European League Against Rheumatism (EULAR)/ American College of Rheumatology(ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) or have biopsy-proven cutaneous lupus erythematosus (CLE).
- •Must have active acute cutaneous lupus erythematosus (ACLE)/ subacute cutaneous lupus erythematosus (SCLE); individuals with mixed skin presentations of lupus skin disease (including DLE) are allowed to enter.
- •CLE Disease Area and Severity Index (CLASI) activity score of ≥ 6 during screening and Day 1, excluding the alopecia component.
- •Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and willingness to undergo skin biopsy at 2 time points.
- •Protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents for the treatment of CLE/SLE (eg, antimalarials, methotrexate (MTX), or other conventional synthetic disease-modifying antirheumatic drug (csDMARDs)) must maintain stable dose(s) for ≥ 60 days prior to randomization through Week 4 of the study.
排除标准
- •Dermatologic disease other than cutaneous manifestations of SLE or CLE that may interfere with assessment of lupus-specific skin lesions.
- •Ongoing or active clinically significant bacterial, fungal or viral infection.
- •History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
- •Uncontrolled health conditions including highly active SLE (e.g. lupus nephritis, neuropsychiatric SLE, vasculitis etc.).
- •History of malignancy.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Edecesertib
Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.
干预措施: Edecesertib (Drug)
Edecesertib
Participants continuing their standard of care therapy will receive edecesertib at a dose of 115 mg orally once daily for up to 4 weeks.
干预措施: Standard of Care (Drug)
Placebo
Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.
干预措施: Placebo (Drug)
Placebo
Participants continuing their standard of care therapy will receive placebo to match edecesertib orally once daily for up to 4 weeks.
干预措施: Standard of Care (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities
时间窗: First dose date up to 4 weeks plus 28 days
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 28 days after last study drug administration.
Percentage of Participants Who Experienced Treatment-emergent Adverse Events
时间窗: First dose date up to 4 weeks plus 28 days
Treatment-emergent Adverse Events (TEAEs) were defined as AEs with onset dates on or after the study treatment start date and no later than 28 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatments.
次要结局
- Pharmacokinetic (PK) Parameter: AUCtau of Edecesertib(Predose and up to 6 hours postdose at Week 4)
- Pharmacokinetic (PK) Parameter: Cmax of Edecesertib(Predose and up to 6 hours postdose at Week 4)