EUCTR2018-003985-15-PT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 433
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 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 law 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
- •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. Subjects without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at screening (ie, in place of screening proctosigmoidoscopy).
- •7. Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies:
- •a. Corticosteroids
- •b. Thiopurines
- •Biologic therapy or JAK inhibitor therapy
- •a. Antitumor necrosis factor alpha (TNFa) antibodies
- •b. Anti-integrin antibodies
- •c. Anti-Interleukin 12/23 antibodies (eg, ustekinumab)
- •d. JAK inhibitors
- •Concomitant treatments:
- •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 CKD 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 potential must meet 1 of the following:
- •- Postmenopausal, defined as no menses for 12 months without an alternative medical cause;
- •- Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
- •b. Non pregnant female who is of childbearing potential must agree to using a highly effect
排除标准
- •1. Severe extensive colitis as evidenced by Physician judgment that subject is likely to require hospitalization for medical care or surgical intervention for UC within 12w following randomization Current evidence of fulminant colitis, toxic megacolon or recent history (last 6months) of toxic megacolon or bowel perforation Previous total or partial colectomy
- •2. Diagnosis of 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 +ve serum ß-hCG at 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 = 6m prior or during Screening period History or presence of second-degree or third-degree atrioventricular block, sick sinus syndrome or periods of asystole for > 3 seconds
- •without functional pacemaker History or presence of recurrent symptomatic bradycardia or recurrent cardiogenic syncope Screening or W0/Day 1 prerandomization vital signs with a heart rate <50bpm OR systolic blood pressure <90mm Hg OR diastolic BP <55mm Hg Screening or W0/Day 1 prerandomization ECG with PR interval >200ms or Fridericia's corrected QT interval =450ms in men or =470ms in women Start, stop, change or planned change in dosage of any anti-arrhythmic drugs (Class I to V) =1w b4 screening or within 1w b4 or after randomization 9. Forced expiratory volume @ 1 second or forced vital capacity <70% of predicted values & FEV1/FVC ratio <0.70 at screening
- •10. Uncontrolled diabetes determined by hemoglobin A1c (HbA1c) >9%
- •@screening or subjects with diabetes with significant comorbid conditions
- •11. History of macular edema or retinopathy
- •12. History of active tuberculosis, history of untreated or inadequately treated latent TB infection, active or latent TB infection at screening 13. clinically significant active infection =28d prior to randomization, required IV medication =14d prior to randomization or that may worsen
- •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 hepatitis B virus at screening (detectable HBV DNA or positive for hepB surface antigenor negative for HBsAg & positive for antihepatitis B core antibody in conjunction with detectable HBV DNA or detectable HBV DNA)
- •16. Have current hepC infection or test +ve for hepC virus (HCV)
- •17. History of an opportunistic infection or 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 & haematological malignancies (except basal cell & in situ squamous cell
- •carcinomas of the skin that have been excised and resolved) or colonic
研究者
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