A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

Gilead Sciences Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

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•Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
•1) 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
•2) Must have met all eligibility criteria from a Gilead-sponsored UC parent protocol
•3) Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
•4) 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
•5) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6, for the duration described
•6) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

•Key Exclusion Criteria:
•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 subject 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 participants
•Use of prohibited medications as outlined in the protocol
•NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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