CTIS2023-508096-36-00进行中（未招募）1 期
A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 48- week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered as monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis - EFC17600 / ESTUARY - EFC17600
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 961 人开始时间: 2024年3月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 961
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
- 0 至 65+（—）
- 性别
- All
入选标准
- •Participants must be at least 12 years of age inclusive, at the time the informed consent is signed., Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate- to-severe AD., Able and willing to comply with requested study visit and procedures., Body weight must be = 25 kg.
排除标准
- •Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST- 2)/EFC17561 (SHORE) clinical trial protocols., Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE)., Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an AE or a SAE deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant., Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study., Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST- 2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.)., Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
研究者
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