EUCTR2016-003179-23-PL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 Small Bowel Crohn’s Disease (SBCD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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) Moderately or severely active CD as defined by screening CDAI 200 to 450 (inclusive).
- •6) Minimum duration of CD of at least 6 months
- •7) Presence of diseased SB segments on MRE with segmental MaRIA score of = 7 in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum.
- •8) Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present.
- •9) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
- •a) Corticosteroids
- •b) Immunomodulators
- •c) TNFa Antagonists
- •d) Vedolizumab
- •e) Ustekinumab
- •10) Meet one of the following tuberculosis (TB) screening criteria:
- •a) No evidence of active or latent TB
- •b) Previously treated for TB
- •c) Newly identified latent TB during screening
- •11) Laboratory parameters within specified intervals
- •12) May be receiving the following drugs (subjects on these therapies must be willing to
- •remain on stable doses for the noted times):
- •a) Oral 5-aminosalicylate (5-ASA) compounds
- •b) Oral corticosteroid therapy
- •c) Azathioprine or 6-MP or methotrexate
- •d) Antibiotics for the treatment of CD
- •13) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug.
- •14) Willing and able to undergo MRE per protocol requirements
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
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) Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures
- •or stenosis.
- •7) Presence of fistulae.
- •8) Evidence of short bowel syndrome.
- •9) Any other complication of CD that could preclude the use of CDAI to assess response to
- •therapy or would confound the evaluation of benefit from treatment with filgotinib.
- •10) Claustrophobia to a degree that prevents tolerance of MRE scanning procedure (sedation is permitted at discretion of investigator).
- •11) Metallic implant of any sort that prevents MRE examination, not limited to but including aneurysm clips, metallic foreign body, vascular grafts or cardiac implants, neural stimulator, metallic contraceptive device, tattoo, body piercing that cannot be removed, cochlear implant; or other contraindication to MRE examination.
- •12) Known hypersensitivity to gadolinium
- •13) Isolated colonic CD, or isolated CD that does not involve some segment of the small bowel.
- •14) Evidence of any other CD manifestation that might require imminent surgery or would
- •possibly confound the evaluation of benefit from treatment with filgotinib.
- •15) Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to Day 1 and are not anticipated to require surgery.
- •16) History of major surgery or trauma within 30 days prior to screening.
- •17) Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon.
- •18) Dependence on parenteral nutrition.
- •19) History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study.
- •20) History or evidence of incompletely resected colonic mucosal dysplasia.
- •21) Stool sample positive for pathogenic Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
- •22) Stool sample positive for ova or parasites test (O&P) unless approved by the Medical Monitor
- •23) 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) Use of any prohibited concomitant medication
- •25) History of leukocytapharesis = 6 months prior to screening.
- •26) 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 requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of Day 1).
- •27) Co-Infection with human immunodeficiency virus (HIV), HBV, or HCV.
- •28) Presence of Child-Pugh Class C hepatic impa
研究者
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