EUCTR2016-003153-15-GB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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 by the following as described in the protocol (section 4.2)
- •6) At screening, has a minimum of 1 (maximum of 3) draining perianal fistulae external openings of = 4 weeks duration as a complication of CD, confirmed by MRI.
- •At least 1 (maximum of 3) of the draining perianal fistulae external openings present at screening must still be draining at the time of randomization.
- •Subjects with other fistula types (enterocutaneous, abdominal) in addition to the required minimum number of perianal fistula may be permitted on discussion with and approval by the Sponsor’s Medical Monitor.
- •7) May have concurrent noncutting perianal seton(s) at screening, which should be removed by the time of randomization
- •8) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following 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 following 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 following 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 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
- •For a complete list of study exclusion criteria, please refer to study protocol (Sections 4.3):
- •1) Pregnant or lactating females.
- •2) Males and females of reproductive potential who are unwilling to adhere to contraceptive guidance
- •3) 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 up to 35 days after the last dose of the study drug.
- •4) Male subjects 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, not limited to but 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 as any of the following as described in protocol section 4.3.
- •10) Presence of current rectovaginal, anovaginal, or enterovesicular fistulae
- •11) Has an abscess > 2 cm or an abscess that the Investigator feels requires drainage based on either clinical assessment or MRI, unless drained and treated at least 4 weeks prior to Day 1, and are not anticipated to require surgery during the study
- •12) Has a CDAI score > 300
- •13) History of major surgery or trauma within 30 days prior to screening
- •14) Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- •15) History of total proctocolectomy, total 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 human immunodeficiency virus (HIV), HBV or HCV
- •19) Presence of Child-Pugh Class C hepatic impairment
- •20) Stool samples positive for Clostridium difficile (C. difficile) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
- •21) Stool sample positive for ova and parasites test (O&P) unless approved by the medical monitor
- •22) Use of any prohibited concomitant medications as described in Section 5.4.2
- •23) Has used any TNFa antagonist = 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. Subjects who have an undetectable serum level of a biologic agent since its last dose using a commercially available assay can undergo study screening without the above-mentioned waiting period.
- •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 (see inclusion criterion 11 for further information)
- •26) History of oppo
研究者
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