2024-513009-30-00招募中2 期
A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn’s Disease
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 572
- 试验地点
- 140
- 主要终点
- Achievement of endoscopic remission at Week 12.
研究概览
简要总结
The objective is to evaluate the safety and efficacy and to assess the mechanistic profile of studied targeted therapies (TaTs)
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
- •Adults 18 to ≤ 75 years old (subjects must also meet the legal age of majority per local law).
- •Subjects' body weight must be ≥ 40 kg at Baseline.
- •Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
- •CDAI ≥ 220 at Baseline.
- •Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
- •Subjects must demonstrate intolerance or inadequate response to 1 or more of the following categories of drugs: oral locally acting steroids, systemic steroids (prednisone or equivalent), immunomodulators, and/or TaTs.
排除标准
- •Subjects who demonstrated intolerance to p19 inhibitors, including risankizumab.
- •Subject who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
- •Subjects who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
结局指标
主要结局
Achievement of endoscopic remission at Week 12.
Achievement of endoscopic remission at Week 12.
次要结局
- Clinical remission per Crohn's disease activity index (CDAI) at Week 12.
- Clinical remission per stool frequency (SF)/abdominal pain score (APS) at Week 12.
- Endoscopic response at Week 12.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (140)
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