2025-522835-32-00招募中2 期
A Phase 2, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of EL219 versus Standard of Care (Liposomal Amphotericin B followed by Voriconazole) for Early Antifungal Therapy of Suspected Invasive Mould Infections
Elion Therapeutics Inc.6 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2026年2月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- 1_All-cause mortality at Day 42 in the Intent-to-Treat (ITT) analysis set
研究概览
简要总结
Evaluate the efficacy and safety of EL219 compared to liposomal amphotericin B (LAmB) followed by voriconazole for early antifungal therapy (EAT) of suspected invasive mould infections (IMIs).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •1_Males or females 18 years and older
- •2_Présenter un risque d’infections fongiques invasives (IFI), au motif d’au moins 1 des éléments suivants : -Avoir reçu une greffe de moelle osseuse d’un donneur allogénique, avec du sang, de la moelle osseuse ou du sang de cordon comme source de cellules souches. -Recevoir actuellement ou avoir reçu récemment (dans un délai de 1 mois) des traitement(s) cytotoxique(s), biologique(s) ou immunomodulateur(s) pour traiter une tumeur maligne hématologique. -Avoir reçu des corticoïdes à des doses minimales moyennes de 0,3 mg/kg/jour d’équivalent prednisone pendant plus de 3 semaines. -Avoir reçu d’autres immunosuppresseurs reconnus agissant sur les lymphocytes T, tels que la cyclosporine, des inhibiteurs du facteur de nécrose tumorale alpha (TNF-α) ou des anticorps monoclonaux spécifiques au cours des 3 derniers mois.
- •3_Has suspected invasive mould infection (IMI) as defined in the protocol
- •4_Must be willing to adhere to dosing, study visit schedule, and mandatory procedures as described in the protocol
排除标准
- •1_Diagnosis of proven or probable IMI within 1 month prior to randomization (including meeting the criteria for proven or probable IMI during the screening period), or relapsed/recurrent IMI which has not responded to other antifungal therapies
- •2_Prior antifungal treatment (azole prophylaxis permitted) for >96 hours prior to randomization or would require use of non-study antifungals during the period of the study
- •3_Systemic bacterial infection diagnosed within the 14 days prior to randomization
- •4_Presence of 1 or more of the following laboratory abnormalities: -Alanine aminotransferase (ALT) ≥5 × upper limit of normal (ULN). -Total serum bilirubin ≥5 × ULN (excluding Gilbert’s Syndrome).-Serum creatinine ≥2 mg/dL or creatinine clearance (CrCL) ≤30 mL/minute
- •5_Presence of 1 or more of the following concomitant diseases: -Known cirrhosis of the liver - Diagnosed symptomatic heart failure -Diagnosed reduced lung function
- •6_Receiving either hemodialysis or peritoneal dialysis
- •7_Personal or family history of long QT interval on ECG (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericia’s formula (QTcF; >470 msec in males and >480 msec in females)
- •8_Prior recipient of orthotopic lung transplant
结局指标
主要结局
1_All-cause mortality at Day 42 in the Intent-to-Treat (ITT) analysis set
1_All-cause mortality at Day 42 in the Intent-to-Treat (ITT) analysis set
2_Serious adverse events (SAEs) and treatment emergent adverse events (TEAEs) categorized in a tiered approach in the Safety analysis set. Tier1 TEAEs include renal, electrolyte, hepatic, infusion-related reactions, photophobia, and photosensitivity. Tier 2 includes all other TEAEs
2_Serious adverse events (SAEs) and treatment emergent adverse events (TEAEs) categorized in a tiered approach in the Safety analysis set. Tier1 TEAEs include renal, electrolyte, hepatic, infusion-related reactions, photophobia, and photosensitivity. Tier 2 includes all other TEAEs
次要结局
- 1_Overall success at Day 42, confirmed by the Data Review Committee (DRC), in the population with proven or probable IA (modified Intent-to-Treat [mITT]) as measured by: - Participant is alive, - favorable composite clinical, mycologic, and radiographic response (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group [EORTC/MSG] criteria)
- 2_Early antifungal therapy (EAT) success at Day 42 in the ITT analysis set defined by non-occurrence of the following: death, receipt of non-study drug systemic antifungal therapy for a cumulative exposure >10 days for progression of disease and/or toxicity, missing data (classified as indeterminate but analyzed as a failure)
- 3_Breakthrough possible, probable, or proven IFI established after 14 days of study drug in the ITT analysis set
- 4_Duration of the initial hospitalization after randomization, in the ITT analysis set
- 5_Motif et durée de réhospitalisation après la sortie d’hôpital à l’issue de l’hospitalisation initiale, dans l’ensemble d’analyse ITT
研究者
Taylor Sandison
Scientific
Elion Therapeutics Inc.
研究点 (6)
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