A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,173
- 试验地点
- 643
- 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 filgotinib treatment study in ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Only 3 arms are blinded in this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC
- •Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
- •Females of childbearing potential must have a negative pregnancy test at Day 1
- •Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 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
排除标准
- •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
- •Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
- •Use of prohibited medications as outlined in the protocol
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Filgotinib 100 mg (blinded dosing)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
干预措施: Placebo (Drug)
Filgotinib 200 mg (blinded dosing)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
干预措施: Filgotinib (Drug)
Filgotinib 100 mg (blinded dosing)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
干预措施: Filgotinib (Drug)
Filgotinib 200 mg (blinded dosing)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
干预措施: Placebo (Drug)
Placebo (blinded dosing)
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
干预措施: Placebo (Drug)
Filgotinib 200 mg (open-label)
Filgotinib 200 mg for up to 336 weeks
干预措施: Filgotinib (Drug)
Filgotinib 100 mg (open-label)
Filgotinib 100 mg for up to 336 weeks
干预措施: Filgotinib (Drug)
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 plus 30 days
次要结局
- Change From Baseline in Components of Mayo Clinic Score (MCS)(Baseline and up to 336 weeks)