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

Galapagos NV0 个研究点目标入组 80 人开始时间: 2022年8月3日最近更新: 2023年9月18日

研究概览

暂无简介。

•- Subjects must be participating in the SELECTION-LTE study, currently on 200 mg filgotinib q.d. and fulfill the following conditions:
•pMCS remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study prior to and including screening of the present study;
•free of corticosteroids for at least 12 weeks prior to and including baseline;
•FCP <=250 µg/g at last observation;
•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.
•This list only contains the key inclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- 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 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 (TB) 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.
•This list only contains the key exclusion criteria.

发起方