CTRI/2017/09/009708进行中（未招募）3 期
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 45
- 主要终点
- Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
研究概览
简要总结
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •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.
排除标准
- •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.
结局指标
主要结局
Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
时间窗: Up to 336 weeks
次要结局
- Change From Baseline in Components of Mayo Clinic Score or MCS(Baseline and up to 336 weeks)
研究者
研究点 (45)
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