EUCTR2018-003986-33-DE进行中（未招募）1 期
A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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, women and adolescents 16 to 80 years of age, inclusive, at the
- •time of assent/consent. Enrollment of subjects < 18 years should be
- •conducted only if acceptable according to local laws and regulations
- •2. Ability to provide written informed consent or assent and to be
- •compliant with the schedule of protocol assessments
- •3. Diagnosed with UC = 3 months prior to screening confirmed by
- •endoscopic and histologic evidence
- •4. Active UC confirmed by endoscopy with = 10 cm rectal involvement.
- •Subjects with proctitis only at baseline who meet the other eligibility criteria for inclusion, including the endoscopic and rectal bleeding
- •criteria for moderate to severe disease,will be capped at 15% of the
- •total subjects enrolled
- •5. Moderately to severely active UC defined as MMS of 4 to 9, including
- •an ES of = 2 and RB score = 1
- •6. Received a surveillance colonoscopy within 12 months before baseline
- •to rule out dysplasia in subjects with pancolitis > 8 years duration or
- •subjects with left-sided colitis > 12 years duration. Subjects without a
- •surveillance colonoscopy within the prior 12 months will have a
- •colonoscopy at screening (ie, in place of screening
- •proctosigmoidoscopy). Any adenomatous polyps must be removed prior
- •to their first dose of study treatment
- •7. Demonstrated an inadequate response to, loss of response to, or
- •intolerance to at least 1 of the following therapies as defined below:
- •Conventional therapy
- •a. Corticosteroids
- •b. Thiopurines
- •Biologic therapy or JAK inhibitor therapy
- •a. Antitumor necrosis factor alpha (TNFa) antibodies (eg, infliximab,
- •adalimumab, golimumab, or biosimilars)
- •b. Anti-integrin antibodies (eg, vedolizumab)
- •c. Anti-interleukin 12/23 antibodies (eg, ustekinumab)
- •d. JAK inhibitors (eg, tofacitinib)
- •8. Subjects are permitted to be receiving a therapeutic dose of the
- •following drugs:
- •Oral 5 ASA compounds provided the dose has been stable for = 2
- •weeks immediately prior to randomization
- •Oral corticosteroid therapy (prednisone at a stable dose = 20 mg/day,
- •budesonide at a stable dose = 9 mg/day, or equivalent steroid) provided
- •the dose has been stable for the 4 weeks immediately prior to the
- •screening endoscopy assessment
- •Immunosuppressive agents such as oral azathioprine or 6
- •mercaptopurine must be discontinued = 2 weeks prior to randomization
- •Probiotics (eg, Culturelle®, Saccharomyces boulardii) provided the
- •dose has been stable for the 2 weeks immediately prior to randomization
- •If oral 5-ASA or corticosteroids have been recently discontinued, they
- •must have been stopped for at least 2 weeks prior to the endoscopy used
- •for the baseline MMS.
- •9. Adequate hematological function defined by white blood cell count =
- •3.5 × 109/L with absolute neutrophil count (ANC) = 1.5 × 109/L,
- •lymphocyte count = 0.8 × 109/L, platelet count = 100 × 109/L, and
- •hemoglobin = 8 g/dL
- 另有 11 项未显示
排除标准
- •1.Severe extensive colitis as evidenced by:
- •Physician judgement that the subject is likely to require hospitalization for medical care or surgical intervention of any kind for UC (eg,colectomy) within 12w following randomization
- •Current evidence of fulminant colitis,toxic megacolon or recent history (within last 6 m) of toxic megacolon,or bowel perforation
- •Previous total or partial colectomy
- •2.Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- •3.Diagnosis of microscopic colitis,ischemic colitis,or infectious colitis
- •4.Hospitalization for exacerbation of UC requiring IV steroids within 12w of screening
- •5.Positive assay or stool culture for pathogens or positive test for Clostridioides difficile toxin at screening
- •6.Pregnancy,lactation,or a positive serum ß-hCG measured during screening
- •7.Clinically relevant neurological,endocrine,metabolic,psychiatric,cognitive
- •impairment,alcohol/drug abuse/dependence,or other major systemic disease making implementation of the protocol or interpretation of the study difficult or would put the subject at risk
- •8.Have any of the following conditions or receiving treatments that may affect cardiovascular function:
- •Myocardial infarction,unstable angina,stroke/transient ischemic attack,decompensated heart failure requiring hospitalization or Class III/IV heart failure =6 m prior to & during the Screening Period
- •History or presence of second-degree or third-degree atrioventricular block,sick sinus syndrome,or periods of asystole for >3seconds without a funcional pacemaker
- •History or presence of recurrent symptomatic bradycardia or recurrent cardiogenic syncope
- •Screening or W0/D1 prerandomization vital signs with a heart rate <50bpm OR systolic blood pressure <90mm Hg OR diastolic BP<55mm Hg & Screening or W0/D1 prerandomization ECG with PR interval >200ms or Fridericia's corrected QT interval QTcF=450 ms in men or = 470ms in women
- •Start,stop,change or planned change in dosage of any anti-arrhythmic drugs (Class I to IV) =1w before screening or within 1w b4 or after randomization
- •9.Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) <70% of predicted values and FEV1/FVC ratio <0.70 at screening
- •10.Uncontrolled diabetes as determined by hemoglobin A1c (HbA1c)>9% at screening, or subjects with diabetes with significant comorbid conditions such as retinopathy
- •11. History of macular edema or retinopathy
- •12.History of active TB, history of untreated or inadequately treated latent TB infection, active or latent TB infection at screening
- •13.A clinically significant active infection =28d prior to randomization
- •14.Have HIV/acquired immune deficiency syndrome or test positive for HIV antibodies
- •15.Have acute or chronic hep B infection or test positive for hep B virus
- •at screening (detectable HBV DNA, or positive for hep B surface antigen, or negative for HBsAg & positive for antihepatitis B core antibody in conjunction with detectable HBV DNA)
- •16.Have current hep C infection or test positive for hep C virus
- •17.History of an opportunistic infection or a history of disseminated herpes simplex or disseminated herpes zoster
- •18.History of or currently active primary or secondary immunodeficiency
- •19.History of cancer within the last 5y, including solid tumors and hematological malignancies (except basal cell ∈ situ squamous cell carcinomas of the skin that have been excised and resolved) or colonic mucosal dysplasia
- •20.History of lymph
研究者
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