2023-506004-93-00已完成2 期
A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
Amgen Inc.69 个研究点 分布在 13 个国家目标入组 167 人开始时间: 2022年4月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 69
- 主要终点
- Clinical remission at week 12
研究概览
简要总结
To evaluate the effect of efavaleukin alfa on induction of clinical remission.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study specific activities or procedures.
- •Diagnosis of UC established >= 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
- •Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy score >=
- •Subjects must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, JAK-inhibitor).
- •Subjects must have stable doses of oral 5-aminosalicylaltes (ASA; stable dose for >= 2 weeks), oral corticosteroids (dose must be <=20mg/day prenisone or its equivalent and must have been stable for >= 2 weeks), budesonide (extended release tablets 9mg/day; stable dose for >= 2 weeks), beclomethasone dipropionate (gastro-resistant prolongued-release tablet 5mg/day; stable dose for >=2 weeks), and conventional immunomodulators (azathioprine, 6-mercaptopurine, methotrexate; stable dose for >=12 weeks).
- •Age >= 18 years to <80years at screening visit, except in South Korea where age >= 19 years to <80 years at screening visit.
排除标准
- •Subjects with diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn’s disease.
- •Subjects with UC limited to the rectum (ie, within 15cm of the anal verge).
- •Subjects with evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
- •Subjects with a history or colectomy.
研究组 & 干预措施
Group with
Test
结局指标
主要结局
Clinical remission at week 12
Clinical remission at week 12
次要结局
- Endoscopic remission at week 12
- Symptomatic remission at week 12
- Combined endoscopic remission and histologic remission of the colon tissue at week 12
- Change from baseline in histological score at week 12 as measured by Geboes score
- Treatment-emergent adverse events
- Clinical response at week 12
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (69)
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