LBCTR2020114568招募中2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 80（—）
- 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 schedule 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/or
- •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:
- •a. CDAI score = 220 and = 450, AND
- •b. Unweighted average worst daily AP score = 2 OR unweighted average daily loose/watery
- •SF score = 4, AND
- •c. 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:
- •a. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
- •b. Immunosuppressants (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate
- •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 evidenced by a negative serum
- •beta-human chorionic gonadotropin (ß-hCG) pregnancy test at Screening and negative urine
- •dipstick pregnancy test at Day 1.
- •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 woman of
- •childbearing potential (WOCBP) 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 treatments). 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.
- 另有 1 项未显示
排除标准
- •1. 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).
- •2. Have stopped, started, or changed the dosage of oral 5-ASA compounds = 2 weeks prior to
- •randomization or do not intend to maintain the same dose during the study.
- •3. Have stopped, started, or changed the dosage of oral corticosteroids (prednisone = 20 mg/day
- •or its equivalent, budesonide = 9 mg/day) = 2 weeks prior to randomization.
- •4. Have a confirmed absolute lymphocyte count < 800 cells/mm3 (< 0.8 × 109 cells/L) at
- •Screening or confirmed absolute neutrophil count < 1000 cells/mm3 (< 1.0 × 109 cells/L) at
- •5. Have confirmed aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
- •> 2 × upper limit of normal (ULN) and total bilirubin > 1.5 × ULN (unless consistent with a
- •history of Gilbert's syndrome) at Screening.
- •6. Used any of the following therapies within the timeframes prior to randomization indicated
- •Within 2 weeks: AZA, 6-MP, MTX, adalimumab or biosimilar (unless there is
- •documentation of an undetectable biologic level), antibiotics (eg, metronidazole,
- •ciprofloxacin) used for the treatment of CD.
- •Within 4 weeks: Infliximab, certolizumab, vedolizumab, ustekinumab or biosimilars
- •(unless there is documentation of an undetectable or subtherapeutic biologic trough level
- •according to the American Gastroenterological Association 2017 Guidelines for
- •Therapeutic Drug Monitoring, or in the Investigator’s opinion, if target trough
- •concentrations have not been proposed), therapeutic apheresis, total parenteral nutrition, IV
- •corticosteroids, or medications that are known to be moderate or strong inhibitors or
- •inducers of cytochrome P450 (CYP) 2C8, CYP2C9, or UGT1A7.
- •Within 8 weeks: 6-Thioguanine, systemic lymphocyte suppressive therapy
- •(eg, cyclosporine, mycophenolate mofetil), or intravenous (IV) immunoglobulin
- •Within 12 weeks: Any investigational agent or device
- •Within 48 weeks: Mesenchymal stem cell transplant (eg, Prochymal)
- •Any time prior to randomization: Sphingosine-1 phosphate receptor modulators
- •(eg, fingolimod, siponimod), a4ß1-integrin receptor antagonist (eg, natalizumab),
- •lymphocyte-depleting therapies (eg, rituximab, cyclophosphamide, bone marrow
- •transplantation, total body irradiation)
- •7. Have a known hypersensitivity to etrasimod or any of the excipients.
- •8. 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 (C. difficile) toxin at Screening. NOTE: Subjects with
- •C. difficile colitis who have been treated with documented evidence of C. difficile toxin
- •clearance = 2 weeks prior to randomization and are symptomatically stable, in the opinion of
- •the Investigator, are eligible for enrollment.
- •9. 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
- •(eg, intestinal stricture with obstructive symptoms, colonic stenoses that are not passable with
- •an adult colonoscope, active perianal/intra-abdominal abscess, active fistula [except for
- •perianal fistula], fulminant colitis).
- •10. Had surgical treatment for intra-abdom
研究者
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