CTIS2022-501263-41-00招募中1 期
A single arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjects with moderate to severe ulcerative colitis. - M21-446
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
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
- •Adult male or female, at least 18 years old at time of the Baseline visit., Diagnosis of UC for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available., Subject 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)., Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or biologics or targeted immunomodulators.
排除标准
- •Anything other than a positive response to the questions in section 5.1 Eligibility Criteria of the Protocol will result in exclusion from study participation.
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