A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
赞助:
AbbVie
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 10, 2018 | ||
| 预计主要完成日期 | December 18, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Percentage of participants with endoscopic improvement[ Time Frame: At Week 8 ] Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | ||
| 正式标题 ICMJE | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | ||
| 简要概况 | Study M15-722 is a Phase 2a study to investigate the efficacy and safety of ABBV-323 in participants with moderate to severe UC who failed prior therapy. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 16, 2023 | ||
| 预计主要完成日期 | December 18, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. - Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available. - Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review). - History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug). Exclusion Criteria: - Participant having an active, chronic, or recurrent infection that based on Investigator's clinical assessment makes the participant an unsuitable candidate for the study. - Participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. - Participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions. - Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total white blood cell (WBC) count >= 3.0*109/L. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：75 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Canada|Italy|United Kingdom|United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | AbbVie | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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