EUCTR2020-004775-40-LV进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,265
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. Subjects 18 to 80 years of age, inclusive, at the time of consent
- •2. Ability to provide written informed consent and to be compliant with the schedules of protocol assessments
- •3. Have CD for = 3 months prior to randomization, involving the ileum and/or colon, at a minimum; diagnosis may be confirmed at any time in the past by endoscopy and histopathology. The screening endoscopy and histopathology reports may serve as source documents for subjects who do not have diagnostic endoscopy reports in their medical chart
- •4. Have moderately to severely active CD at Screening, defined as:
- •- Crohn's Disease Activity Index (CDAI) score = 220 and = 450, AND
- •- Unweighted average worst daily abdominal pain (AP) score = 2 unweighted average daily loose/watery stool frequency (SF) score = 4,
- •- Simple Endoscopic Score in Crohn's disease (SES-CD) of = 6 or SES-CD = 4 for subjects with isolated ileal disease
- •5. Demonstrated inadequate response, loss of response to, or intolerance to = 1 of the following therapies for the treatment of CD
- •- Oral corticosteroids (eg, prednisone [or its equivalent] or budesonide)
- •- Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate)
- •- Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
- •- Integrin receptor antagonist (eg, vedolizumab)
- •- Interleukin-12/-23 antagonist (eg, ustekinumab)
- •6. Females of childbearing potential must be nonpregnant
- •7. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
- •a. A female who is not of childbearing potential must meet 1 of the following:
- •- Postmenopausal, defined as no menses for 12 months without an alternative medical cause and confirmed by follicle-stimulating hormone (FSH) within postmenopausal range according to local standards
- •- Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy
- •b. A female who is of childbearing potential must agree to using a highly effective contraception method during treatment and for 4 weeks following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly.
- •The following are considered highly effective birth control methods:
- •- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal
- •- Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted
- •- Intrauterine device (IUD)
- •- Intrauterine hormone-releasing system (IUS)
- •- Bilateral tubal occlusion
- •- Vasectomized partner, provided that partner is the sole sexual partner of the FOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success
- •- Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study drug). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable
- •c. A male must agree to using condoms during treatment and for 4 weeks following treatment
- •SS3-M, SS4-E: Females and males must continue to meet contraception criterion described above
- •Are the trial subjects under 18?
排除标准
- •Key exclusion criteria:
- •- 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 Clostridioides difficile toxin at Screening
- •- Have functional or post-operative short-bowel syndrome (ie, have > 3 small bowel resections) 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. Subjects who have undergone previous colonic resection or ileocolectomy must have > 25 cm of colon remaining
- •- Have an ileostomy or a colostomy
- •- Have a serious infection requiring intravenous antibiotic(s)/medication(s) = 4 weeks prior to randomization
- •- Have primary or secondary immunodeficiency syndromes, history of organ transplant, history of an opportunistic infection, history of disseminated herpes simplex or herpes zoster, have or test positive for HIV, HBV, or active HCV
- •- Lactating female who is breastfeeding
研究者
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