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

Arena Pharmaceuticals, Inc.0 个研究点目标入组 330 人2019年9月17日

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注册库

who.int

开始日期

2019年9月17日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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

•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 (eg,colectomy) 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 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 12 weeks 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