EUCTR2016-003153-15-IT进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn¿s Disease - This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as
GILEAD SCIENCES INCORPORATED0 个研究点目标入组 75 人开始时间: 2020年11月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For a complete list of study inclusion criteria, please refer to study protocol (sections 4.2):
- •1) Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
- •3) Females of childbearing potential must have a negative pregnancy test at screening and baseline
- •4) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •5) Documented diagnosis of Crohn's disease with a minimum disease duration of 3 months documented as described in the protocol (section 4.2)
- •6) Has a minimum of 1 (maximum of 3) draining perianal fistulas of = 4 weeks' duration before enrollment as a complication of CD, confirmed by
- •MRI at Screening. Other types of fistulas (enterocutaneous, abdominal)
- •except rectovaginal fistulas are permitted, but the number of these other fistulas should be limited up to 3.
- •7)May have concurrent noncutting perianal seton(s) at screening, which must be removed = 14 days prior to randomization
- •8) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the agents (depending on current country treatment recommendations/guidelines) as described in the protocol (section 4.2)
- •9) Is willing and able to undergo MRI per protocol requirements
- •10) Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
- •11) Meet one of the tuberculosis (TB) screening criteria as described in the protocol (section 4.2)
- •12) Laboratory parameters (subjects who fail to meet the parameters of any of the below reference laboratory tests may be retested once at discretion of investigator prior to being considered a screen failure) as described in the protocol (section 4.2)
- •13) May be receiving the drugs (subjects on these therapies should be willing to remain on stable doses for the noted times) as described in the protocol (section 4.2)
- •14) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
- •15) Must be up to date on colorectal cancer screening and surveillance as standard of care according to the local guidelines
- •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 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1) Pregnant or lactating females
- •2) Males and females of reproductive potential unwilling to adhere to contraceptive guidance
- •3) Females who may wish to become pregnant and/or plan egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and up to 35days after the last dose of the study drug.
- •4) Males unwilling to refrain from sperm donation during the study and for at least 90 days after the last dose of study drug.
- •5) Known hypersensitivity to filgotinib its metabolites or formulation excipients
- •6) Claustrophobia to a degree that prevents tolerance of MRI scanning procedure (sedation is permitted at discretion of investigator)
- •7) Metallic implant of any sort that prevents MRI examination including aneurysm clips metallic foreign body vascular grafts or cardiac implants neural stimulator metallic contraceptive device body piercing that cannot be removed cochlear implant or other contraindication to MRI examination
- •8) Known hypersensitivity to gadolinium
- •9) Currently have complications of CD
- •10) Presence of current rectovaginal fistula
- •11) Has an abscess > 2cm or an abscess that the Investigator feels requires drainage based oneither clinical assessment or MRI unless drained and treated at least 4 weeks prior to Day 1, and are not anticipated to require surgery
- •12) Has a CDAI score> 400
- •13) History of major surgery or trauma within 30 days prior to screening
- •14) Presence of ulcerative colitis indeterminate colitis ischemic colitis fulminant colitis or toxic mega-colon
- •15) History of total colectomy hemi-colectomy presence of ileostomy or colostomy or likely requirement for surgery during the study
- •16) Dependence on parenteral nutrition
- •17) History or evidence of incompletely resected colonic mucosal dysplasia
- •18) Infection with HIV HBV or HCV
- •19) Presence of Child-Pugh Class C hepatic impairment
- •20) Stool samples positive for pathogenic Clostridium difficile (C. difficile) toxin pathogenic E. coli Salmonella species, Shigella spp Campylobacter spp or Yersinia spp.
- •21) Stool sample positive for ova and parasites test unless approved by the medical monitor
- •22) Use of any prohibited concomitant medications
- •23) Must not have used any TNFa antagonist or vedolizumab = 8 weeks prior to screening ustekinumab IV or SC = 12 weeks prior to screening,or any other biologic agent = 8 weeks prior to screening or within 5 times the half-life of the biologic agent prior to screening whichever is longer
- •24) Active clinically significant infection or any infection requiring hospitalization or treatment with intravenous anti-infectives within 30 days of screening (or 8 weeks of Day 1) or any infection other than related to the fistula(s) requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of Day 1)
- •25) Active TB or history of latent TB that has not been treated
- •26) History of opportunistic infection or immunodeficiency syndrome
- •27) History of disseminated Staphylococcus aureus
- •28) History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any history of disseminated herpes simplex disseminated herpes zoster ophthalmic zoster or central nervous system zoster
- •29) Administration of live or attenuated vaccine within 30 days of randomization
- •30) Any chronic medical condition (including cardiac or pulmonary disease)or psychiatric problem (including alcohol or drug abuse) that would make the subject unsuitable for the study or would prevent compliance
研究者
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