EUCTR2017-003299-30-IT进行中（未招募）1 期
A Multicenter, Long-Term Extension to Evaluate the Long Term Safety and Maintenance of Treatment Effect of Mirikizumab in Patients with Moderate to Severe Plaque Psoriasis - OASIS-3
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 1,793 人开始时间: 2021年6月17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
- 1,793
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Aver completato l'ultima visita di un periodo accettabile di uno degli studi di origine (Studi AMAF, AMAJ, AMAK, AMBK)
- •- Le pazlentl di sesso femmlinile devono ottenere un test di gravldanza negativo prima dell'avvio del trattamento e devono impegnarsl a utilizzare un metodo contraccettivo per tutta la durata della sperimentazione
- •- Aver fornito il proprio consenso scritto in quanto legalmente adulto secondo le regolamentazioni locali
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1664
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 129
排除标准
- •- Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal,endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect patient safety within the study or of interfering with the interpretation of data.
- •- Have a known hypersensitivity to mirikizumab or any component of this investigational product.
- •- Have had investigational product permanently discontinued during a previous mirikizumab study.
- •- Have had temporary investigational product interruption at any time during or at the final study visit of a previous mirikizumab study and, in the opinion of the investigator, restarting mirikizumab would pose an unacceptable risk for the patient's participation in the study.
- •- Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
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