EUCTR2015-001924-40-HR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 adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 798
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 daily liquid or soft 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, AZA, 6-MP, or MTX); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab, or vedolizumab)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 658
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. diagnosis of UC, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, diverticular disease-associated colitis, or colitis due to immunodeficiency.
- •2. local manifestations of CD such as abscesses, short bowel syndrome, or other disease complications for which surgery might be indicated or which could confound the evaluation of efficacy.
- •3. strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded.
- •4. intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit.
- •5. ileostomy or a colostomy.
- •6. prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks prior to the Screening Visit.
- •7. intravenous (IV) corticosteroids within 2 weeks prior to the Screening Visit.
- •8. changed or discontinued the dose of oral aminosalicylates within 2 weeks prior to the Screening Visit.
- •9. changed or discontinued the dose of oral corticosteroids (prednisone = 20 mg/day or equivalent, budesonide = 9 mg/day) within 3 weeks prior to the Screening Visit.
- •10. Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until Week 12 visit.
- •11. immunosuppressants (eg, AZA, 6-MP, or MTX) within 12 weeks prior to the Screening Visit and has changed or discontinued the dose of immunosuppressants within 8 weeks prior to the Screening Visit.
- •12. topical GI treatments, such as, 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit.
研究者
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