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

Galapagos NV0 个研究点目标入组 1,000 人开始时间: 2016年12月15日最近更新: 2023年8月28日

研究概览

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•Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
•Criterion modified per amendment 9
•2.1) Must have enrolled in a CD parent protocol, GS-US-419-4015, GSUS419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
•Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
•Criterion modified per amendment 9
•4.1) Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
•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
•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 920
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study.
•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 or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
•Criterion modified per amendment 9
•4.1) Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 30 days after the last dose of study drug
•Criterion modified per amendment 9
•6.1) Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
•Use of prohibited concomitant medications as outlined in the protocol

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