2024-516199-14-00招募中3 期
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Safety, evaluated through AEs, clinical laboratory tests, and vital signs
研究概览
简要总结
To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in UC
研究设计
- 分配方式
- Randomized
- 主要目的
- A Long-term Extension Study To Evaluate The Safety Of Filgotinib In Subjects With Ulcerative Colitis
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •Must have enrolled in Gilead-sponsored UC parent protocol GS-US-4183898 or any other Gilead/Galapagos-sponsored filgotinib treatment study in Ulcerative Colitis
- •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 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
- •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 clinical study protocol
- •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
- •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
- •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 of the last dose of the study drug
- •Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
- •Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
- •Use of prohibited concomitant medications as outlined in the protocol
结局指标
主要结局
Safety, evaluated through AEs, clinical laboratory tests, and vital signs
Safety, evaluated through AEs, clinical laboratory tests, and vital signs
次要结局
- To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)
研究者
Alfasigma S.p.A.
Scientific
Alfasigma S.p.A.
研究点 (5)
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