JPRN-jRCT2080223167已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 383
研究概览
简要总结
The results of Study SC-3027 demonstrate that vedolizumab SC is an effective and well-tolerated maintenance treatment for participants with moderately to severely active UC and the treatment effects with SC are consistent with IV maintenance therapy. Except for injection site reactions, the safety and immunogenicity of vedolizumab SC was similar to vedolizumab IV in this study.
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 ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
- •2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore >=2)
- •3. Evidence of UC extending proximal to the rectum (>=15 cm of involved colon).
- •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 or toxic megacolon at the initial Screening Visit.
- •2. Extensive colonic resection, subtotal or total colectomy.
- •3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •4. Prior exposure to investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- •5. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
- •6. Prior exposure to vedolizumab
- •7. Surgical intervention for UC required at any time during the study.
- •8. History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia.
- •9. Suspected or confirmed diagnosis of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- •10. Active infections
- •11. Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection, HIV or tuberculosis (active or latent), identified congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included.
- •12. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.
研究者
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