A Long-Term Extension Study to Evaluate the Safety of filgotinib in Subjects with Crohn’s Disease

Gilead Sciences Inc0 个研究点目标入组 72 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
•Must have met all eligibility criteria from a Gilead-sponsored CD parent protocol
•Females of childbearing potential must have a negative pregnancy test at Day 1
•Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method of contraception as described in the study protocol, for the duration described
•Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
•Must have completed all required procedures or met protocol specified
•efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib
•treatment study for CD

•Known hypersensitivity to the study drug
•Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol
•Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the study protocol
•Use of prohibited medications as outlined in the study protocol
•NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply

发起方