CTIS2022-501523-24-00招募中1 期
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) - GS-US-497-6486
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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 1. 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 1. 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. Note: Other protocol defined Inclusion criteria may apply.
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 1., 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 Exclusion criteria may apply.
研究者
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