A Phase 2, Open-Label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects with Active Crohn's Disease - GED-0301-CD-005

CELGENE CORPORATIO0 个研究点目标入组 18 人2018年3月7日

概览

暂无简介。

注册库

who.int

开始日期

2018年3月7日

结束日期

2018年4月23日

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

CELGENE CORPORATIO

•1\. Subject is a male or female \= 18 years of age at the time of signing the informed consent form (ICF).
•2\. Subject must understand and voluntarily sign an ICF prior to any study\-related assessments / procedures being conducted.
•3\. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
•4\. Subject must have a diagnosis of CD with a duration of at least 3 months prior to Screening Visit 1\.
•5\. Subject must have a diagnosis of ileitis, ileocolitis or colitis, as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging
•\[MRI], or computed tomography \[CT] scan).
•6\. Subject must have active disease, defined as a CDAI score \= 220 and \= 450 at screening.
•7\. Subject must have a total SES\-CD \= 6 at screening, or the ileum segmental SES\-CD \= 4
•at screening.
•8\. Subject must have failed or experienced intolerance to at least one of the following:

•1\. Subject has CD involvement of the upper gastrointestinal tract.
•2\. Subject has a diagnosis of UC, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease\-associated colitis.
•3\.Subject has local manifestations of CD such as strictures, abscesses, short bowel syndrome or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy.
•4\.Subject had an intestinal resection within 6 months or any intra\-abdominal surgery within3 months prior to Screening Visit1\.
•5\.Subject has an ileostomy or a colostomy.
•6\. Subject had prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within8weeks prior to Screening Visit1\.
•7\. Subject has received intravenous (IV) corticosteroids within2weeks prior to Screening
•8\.Subject has initiated, changed or discontinued the dose of oral aminosalicylates within2weeks prior to Screening Visit1\.
•9\. Subject has initiated, changed or discontinued the allowed dose of oral corticosteroids (prednisone \= 20 mg/day or equivalent, budesonide \= 9 mg/day) within3weeks prior to
•Screening Visit1\.