CTRI/2023/05/052646尚未招募3 期
A randomized, double-blind, controlled, multi-center study to evaluate the efficacy and safety of dose de-escalation of orally administered Filgotinib in subjects with ulcerative colitis in clinical remission.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Galapagos NV
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48
研究概览
简要总结
Participantswho are in clinical remission on 200 mg Filgotinib once daily (q.d.) for atleast 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GLPG0634-CL-307,GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized inthis study. The primary objective of this study is to evaluate the efficacy of Filgotinibin participants in stable clinical remission on 200 mg Filgotinib q.d. for whomthe dose was decreased to 100 mg q.d. compared to participants remaining on 200mg q.d.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must be participating in the SELECTION-LTE study, currently on 200 mg Filgotinib q.d. and fulfill the following conditions: a) pMCS remission1 over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study prior to and including screening of the present study b) free of corticosteroids for at least 12 weeks prior to and including baseline c) FCP less than or equals to 250 microgram per gram at last observation d) sigmoidoscopy ES of 0 or 1 (local score) at screening.
- •Female subjects of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must agree to continued monthly urine dipstick pregnancy testing during Filgotinib treatment.
- •Male subjects and female subjects of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.
- •Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of Filgotinib in the study.
排除标准
- •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.
- •Subject has a known hypersensitivity to Filgotinib ingredients or history of a significant allergic reaction to Filgotinib ingredients as determined by the investigator.
- •Female subject who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and or or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.
- •Male subject unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product.
- •Subject is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
- •Subject has a positive QuantiFERON® tuberculosis test at screening or subject has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.
- •History of malignancy except for subjects who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
- •Subject meets discontinuation criteria of the SELECTION-LTE study.
结局指标
主要结局
Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48
时间窗: Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48
次要结局
- Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare(Baseline (Day 1) up to 216 weeks)
- Change From Baseline in C-Reactive Protein (CRP) up to Week 48(Baseline, up to Week 48)
- Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48(Baseline, Week 48)
- Time to ES-Confirmed UC Flare(Baseline (Day 1) up to 216 weeks)
- 6.Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation(Baseline up to 216 weeks)
- Change From Baseline in Fecal Calprotectin (FCP) up to Week 48(Baseline, up to Week 48)
研究者
研究点 (10)
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