JPRN-jRCT2080223331已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 644
研究概览
简要总结
The results of Study SC-3031 demonstrate the efficacy and safety of vedolizumab SC as maintenance treatment for participants with moderately to severely active CD.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.
- •2. Moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 450 and 1 of the following:
- •- C-reactive protein (CRP) level >2.87 mg/L OR
- •- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 cm in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
- •- Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
- •3. CD involvement of the ileum and/or colon, at a minimum.
- •4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-alpha) antagonists.
排除标准
- •1. Evidence of abdominal abscess at Screening.
- •2. Extensive colonic resection, subtotal or total colectomy.
- •3. History of >3 small bowel resections or diagnosis of short bowel syndrome.
- •4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •5. Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- •6. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
- •7. Prior exposure to vedolizumab.
- •8. Surgical intervention for CD required at any time during the study.
- •9. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
- •10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- •11. Active infections.
- •12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included.
- •13. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
研究者
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