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 and Company0 个研究点目标入组 1,793 人开始时间: 2019年1月22日最近更新: 2019年4月30日

研究概览

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•-Have completed the last visit of an eligible study period of 1 of the originator studies (Study AMAF, AMAJ, AMAK, or AMBK).
•- Female patients must test negative for pregnancy prior to initiation of treatment and agree to use contraception for the duration of the trial
•-Have given written informed consent as a legal adult according to local regulations
•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

•- 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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