EUCTR2015-001925-18-SK进行中（未招募）1 期
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,064
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
- •Diagnosis of CD with a duration of at least 3 months prior to the Screening Visit
- •Presence of ileitis, ileocolitis or colitis, as determined by ileocolonoscopy at screening.
- •Active disease, defined as a CDAI score = 220 and = 450 at screening.
- •Must have a 7-day average stool frequency = 3.5 or abdominal pain = 1.5 at screening.
- •Must have a total SES-CD = 6 at screening, or the ileum segmental SES-CD = 4 at screening
- •Must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (ie. azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]); or biologics for the treatment of CD (ie. infliximab, adalimumab, certolizumab or vedolizumab)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1010
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
- •Local manifestations of CD such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
- •Strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, colonic strictures that are not passable with an adult colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded.
- •Any intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
- •Prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks prior to the Screening Visit
- •Use of intravenous (IV) corticosteroids within 2 weeks prior to the Screening Visit
- •Use of topical GI treatments such as 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit
- •Use of bile acid sequestrants, (eg, cholestyramine) within 3 weeks prior to the Screening Visit
- •Prior treatment with biologics for the treatment of CD (approved or investigational), other than infliximab, adalimumab, certolizumab or vedolizumab
- •Prior treatment with more than 3 biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab or vedolizumab).
- •Treatment with a biologic within 8 weeks prior to the Screening Visit, or 5 elimination half lives, whichever is longer.
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