CTIS2023-508679-34-00招募中1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis - ANB030-204
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Male or female who is =18 years, 2. Clinical diagnosis of UC for > 90 days prior to Day 1, including appropriate documentation of biopsy results that are consistent with UC, based on the assessment of the Investigator, 3. Moderate to severe active UC defined as a mMS = 5 with an endoscopy subscore = 2 (based on a central reader review) at Baseline., 5. Surveillance colonoscopy did not detect potential dysplasia or colon cancer performed within 1 year of Day 1, 6. Subject has completed at least 3 consecutive or 4 nonconsecutive eDiary entries within 7 days before Day 1 (excluding days during bowel preparation for endoscopy), 4. Subject has a history of an inadequate response, loss of response, or intolerance to any combination of at least 2 of conventional UC therapy classes, defined as, but not limited to, [1] aminosalicylates (e.g., sulfasalazine, mesalamine, etc.), [2] corticosteroids, (e.g. prednisone, budesonide, dexamethasone, etc.), [3] immunosuppressants (e.g. azathioprine, methotrexate, etc.), [4] calcineurin inhibitors (e.g. cyclosporine, tacrolimus, etc.)
排除标准
- •1. Clinical diagnosis of Crohn’s disease, indeterminate colitis, fulminant colitis, and/or toxic megacolon, 2. Disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy, 3. History of colectomy, ileoanal pouch, Kock pouch, or ileostomy or is planning bowl surgery, 4. Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator, 5. Clostridioides difficile infection within 30 days before Screening or a positive C. difficile toxin stool assay result at Screening, or infection with other intestinal pathogens within the 30 days before Screening, 6. Prior or current gastrointestinal (GI) dysplasia in any biopsy performed before or during the Screening endoscopy, 7. Evidence of colonic infection during Screening, 8. History of an inadequate response, loss of response, or intolerance to any combination of 4 or more advanced UC therapy classes defined as, but not limited to, [1] anti-TNF antibodies (e.g., adalimumab, golimumab, infliximab), [2] anti-IL-12/23 biologics (e.g., ustekinumab, mirikizumab), [3] anti-integrins (e.g., vedolizumab), [4] oral JAK inhibitors (e.g., tofacitinib, upadacitinib), [5] oral S1P receptor modulators (e.g., ozanimod)., 9. Current treatment with any of the following: o Oral corticosteroids equivalent to prednisone > 20 mg per day o Oral corticosteroids equivalent to prednisone = 20 mg per day that have been at a stable dose for < 4 weeks before Day 1 o Methotrexate or azathioprine o Immunomodulatory biologic agents (including investigational biologics) received within 12 weeks or 5 half-lives (whichever is longer) immediately before Randomization. o Live or live-attenuated vaccines within 12 weeks before the first dose of study drug. o Fecal-microbial transplantation within 30 days prior to Day 1
研究者
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