EUCTR2015-001249-10-IT进行中（未招募）1 期
A Phase 2, Double-blind, Randomized, Placebo-Controlled, MulticenterStudy Evaluating the Safety and Efficacy of GS-5745 in Subjects withModerately to Severely Active Crohn's Disease - GS-US-395-1663
GILEAD SCIENCES INCORPORATED0 个研究点目标入组 175 人开始时间: 2018年2月21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
- 175
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
- •Subjects must meet all of the following inclusion criteria to be eligible
- •for participation in this
- •1) Must have the ability to understand and sign a written informed
- •consent form, which must be obtained prior to initiation of study
- •2) Males or non-pregnant, non-lactating females, ages 18 to 75 years,
- •inclusive based on the date of the 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 as described in the protocol
- •5) Documented diagnosis of Crohn's disease with a minimum disease
- •duration of 6 months with involvement of the ileum and/or colon at a
- •6) Moderately to severely active Crohn's disease as defined by a CDAI
- •total score between
- •220-450 (inclusive) AND with protocol defined parameters
- •7) Within the previous 5 years, demonstrated an inadequate clinical
- •response, loss of response to, or intolerance of at least one of the
- •following agents as defined in the protocol:
- •a) Corticosteroids
- •b) Immunomodulators
- •c) TNFa Antagonists
- •d) Vedolizumab
- •8) Protocol defined Laboratory parameters
- •9) May be receiving the following drugs:
- •a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose has
- •been stable for at least 2 weeks prior to screening
- •b) Oral corticosteroid therapy (prednisone at a stable dose = 30 mg/day
- •or budesonide at a
- •dose of = 9 mg/day) provided the dose has been stable for 2 weeks prior
- •to screening
- •c) Antidiarrheals for chronic diarrhea
- •d) Azathioprine or 6-MP or methotrexate provided the dose has been
- •stable for 4 weeks
- •prior to screening
- •e) Antibiotics for the treatment of Crohn's Disease (e.g., metronidazole,
- •ciprofloxicin)
- •provided the dose has been stable for the 2 weeks prior to screening or
- •is consistent with
- •subject's standard low-dose regimen
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 155
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Pregnant or lactating females
- •2) Males and females of reproductive potential who are unwilling to use
- •an effective
- •contraception during the study or complete abstinence from intercourse
- •from the date of
- •screening to study completion and up to 90 days post last dose of the
- •3) Females who may wish to become pregnant and/or plan to undergo
- •XML File Identifier: ALargj8L4kd2K4NzrZc/9suyezY=
- •egg donation or egg
- •harvesting for the purpose of current or future fertilization during the
- •course of the study and
- •up to 30 days of the last dose of the study drug
- •4) Male subjects unwilling to refrain from sperm donation for at least 90
- •days after the last dose
- •of study drug
- •5) Known hypersensitivity to GS-5745
- •6) Evidence of abscess at screening
- •7) Extensive colonic resection (subtotal or total colectomy) or history of
- •> 2 small bowel resections
- •8) Ileostomy, colostomy, or symptomatic stenosis of the intestine
- •9) Current use of oral corticosteroids at a dose equivalent to > 30
- •mg/day of prednisone
- •10) Ulcerative colitis or indeterminate colitis
- •11) Short bowel syndrome
- •12) Stool sample positive for Clostridium difficile (C. difficile) toxin, E.
- •coli, Salmonella,
- •Shigella, Campylobacter or Yersinia
- •13) Treatment with infliximab, adalimumab, natalizumab, golimumab,
- •vedolizumab,
- •certolizumab, or any other monoclonal antibody within 4 weeks of
- •14) Clinically significant active infection
- •15) History or evidence of colonic mucosal dysplasia
- •16) Chronic medical or psychiatric problem that may interfere with
- •subject's ability to comply with study procedures
- •17) Co-infection with chronic HIV, hepatitis B, or hepatitis C
- •18) Active tuberculosis (TB) infection or history of latent tuberculosis
- •that has not been treated
- •19) Alcohol or drug abuse (in the opinion of the Investigator) that would
- •interfere with
- •20) History of malignancy within the last 5 years except for subjects
- •who have been treated or resected for non-melanoma skin cancer or
- •cervical carcinoma in situ
- •21) Any other investigational therapy or investigational biologics use
- •within 4 weeks of
- •22) Any chronic medical condition (including, but not limited to, cardiac
- •or pulmonary disease) that, in the opinion of the Investigator, would
- •make the subject unsuitable for the study or would prevent compliance
- •with the study protocol
研究者
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