EUCTR2018-003985-15-RO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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 372
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
- •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.
- •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. Oral 5-aminosalicylic acid (5-ASA) compounds
- •b. Corticosteroids
- •c. 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. JAK inhibitors (eg, tofacitinib)
- •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
- •? Antidiarrheal (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea
- •If oral aminosalicylates 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. Vital signs at screening and pre randomization taken in the sitting position: heart rate = 50 bpm, systolic blood pressure (BP) = 90 mm Hg, and diastolic BP = 55 mm Hg
- •10.Screening and pre randomization 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities
- •11.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
- •12.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 = 3.0 × ULN. Subjects with an isolated total bilirubin and normal AST and ALT diagnosed with Gilbert’s syndrome may participate
- •13. Adequate renal function defined by an estimated glomerular filtration rate = 30 mL/min/1.73 m2 by the CKD-EPI equation at screening
- •14.Eligible women of childbearing potential must be:
- •a. Non pregnant, evidenced by a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and a urine dipstick pregnancy test at Day 1
- •b. Not breastfeeding
- •15.Both men and women subjects agree to use a highly effective method of birth control throughout the entire study period, from informed consent through the adverse even
排除标准
- •1. Severe extensive colitis as evidenced by:
- •? Physician judgment that the subject is likely to require hospitalization for medical care or surgical intervention of any kind for UC within 12 weeks of baseline
- •? Current evidence of fulminant colitis, toxic megacolon or recent history (within last 6 months) 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 intravenous (IV) steroids within 12 weeks of screening
- •5. Positive assay or stool culture for pathogens or positive test for Clostridium difficile toxin at screening
- •6. Pregnancy, lactation, or a positive serum ß-hCG measured during screening
- •7. Clinically relevant hematologic, hepatic, neurological, pulmonary, ophthalmological, endocrine, metabolic, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or would put the subject at risk
- •8. Recent history (within 2 months of the Screening Visit) of cardiovascular disease, including myocardial infarction or unstable angina
- •9. Any history of the following, unless treated with an implanted pacemaker or an implanted cardioverter-defibrillator with pacing:
- •? History or presence of symptomatic bradycardia
- •? History of sick sinus syndrome or neurocardiogenic syncope
- •? Second or third-degree AV block
- •? Periods of asystole > 3 seconds
- •10. Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 70% of predicted values & FEV1/FVC ratio < 0.70 at screening
- •11. Uncontrolled diabetes as determined by hemoglobin A1c (HbA1c) > 9% at screening, or subjects with diabetes with significant comorbid conditions such as retinopathy
- •12. History of macular edema or retinopathy
- •13. Current or past history of active tuberculosis (TB), history of untreated latent TB infection, or test positive for latent TB infection at screening.
- •14. Known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or during screening or oral antibiotics within 14 days prior to screening.
- •15. Have human immunodeficiency virus (HIV)/acquired immune deficiency syndrome or test positive for HIV antibodies at screening
- •16. Have acute or chronic hepatitis B infection or test positive for hepatitis B virus (HBV) at screening, or negative for HBsAg and positive for antihepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA)
- •17. Have current hepatitis C infection or test positive for hepatitis C virus (HCV) at screening as defined by positive for hepatitis C antibody and detectable HCV RNA
- •18. History of an opportunistic infection (eg, pneumocystis carinii, cryptococcal meningitis, progressive multifocal leukoencephalopathy) or serious bacterial, viral, or fungal infections (eg, disseminated herpes simplex, disseminated herpes zoster) and requiring IV medication(s) = 3 weeks prior to randomization
- •19. History of or currently active primary or secondary immunodeficiency
- •20. History of cancer within the last 5 years, including solid tumors and haematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and reso
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