EUCTR2018-003986-33-AT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
- •10. Adequate hepatic function defined by a total bilirubin level = 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =2.0 × ULN. Subjects with an isolated total bilirubin and normal AST and ALT diagnosed with Gilbert's syndrome may participate
- •11. Adequate renal function defined by an estimated glomerular
- •filtration rate = 30 mL/min/1.73 m2 by the Chronic Kidney Disease
- •Epidemiology Collaboration equation at screening
- •12. 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 potentia
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 6m) 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
- •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 hepB virus at screening (detectable HBV DNA, or positive for hepB surface antigen, or negative for HBsAg & positive for antihepatitis B core antibody in conjunction with detectable HBV DNA)
- •16.Have current hepC infection or test positive for hepC 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 lymphoprol
研究者
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