EUCTR2019-002895-14-GB进行中（未招募）1 期
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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
- •1. Men or women 18 to 80 years of age,
- •2. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- •3. Diagnosed with CD = 3 months
- •4.Have moderately to severely active CD at Screening
- •5.Demonstrated inadequate response, loss of response to, or intolerance to = 1 of the following therapies for the treatment of CD:
- •a.Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
- •b.Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6 MP], or methotrexate [MTX])
- •c.Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
- •d.Integrin receptor antagonist (eg, vedolizumab)
- •e.Interleukin 12/ 23 antagonist (eg, ustekinumab)
- •6.Females of childbearing potential must be nonpregnant
- •7.Females of childbearing potential and males must use contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- History of inadequate response (ie, primary non response) to agents from = 2 classes of biologics marketed for the treatment of CD (ie, TNFa antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
- •- Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridium difficile toxin at Screening.
- •- Have functional or post operative short bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
- •- Had surgical treatment for intra abdominal abscesses = 8 weeks prior to randomization or surgical treatment for perianal abscesses = 4 weeks prior to randomization.
- •- Had intestinal resection = 24 weeks prior to randomization or other intra abdominal surgeries = 12 weeks prior to randomization.
- •- Have an ileostomy or a colostomy.
- •- Have a serious infection requiring IV antibiotics/medication(s) = 4 weeks prior to randomization.
- •- Have primary or secondary immunodeficiency syndromes, opportunistic infection, or infection with HIV, HBV, HCV or tuberculosis (active or latent):.
- •- Have a clinically relevant cardiovascular condition or receiving treatments that may effect cardiovascular function
- •- Have active retinopathy or macular oedema.
- •- Have forced expiratory volume at 1 second or forced vital capacity < 70% of predicted values at Screening.
- •- Lactating female who is breastfeeding.
- •- Any acute illnesses or medical conditions including cognitive impairment and alcohol/drug abuse/dependence, or signs/symptoms suspicious for a serious disease that, in the Investigator's opinion, could put the subject at increased risk for safety event(s) or interfere with protocol-specified procedures or adherence with study treatment.
研究者
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