2022-501263-41-00已完成2 期
A single arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjects with moderate to severe ulcerative colitis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 12
- 主要终点
- The primary endpoint is the achievement of endoscopic improvement (Mayo ESS of 0 or 1) at Week 8.
研究概览
简要总结
To characterize the safety and efficacy of ABBV-668 as treatment in adult subjects with moderately to severely active UC.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Phase 2a, multicenter, open label proof of concept study to investigate the efficacy and safety
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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.
结局指标
主要结局
The primary endpoint is the achievement of endoscopic improvement (Mayo ESS of 0 or 1) at Week 8.
The primary endpoint is the achievement of endoscopic improvement (Mayo ESS of 0 or 1) at Week 8.
次要结局
- The estimands corresponding to the secondary efficacy objectives are: For each binary secondary endpoint specified in Section 3.3: The difference in the proportion of subjects achieving a response in ABBV-668 treatment group in the ITT Population versus in historical placebo group, where subjects will be counted as non-responders after the start of rescue medication (initiation or dose escalation of UC-related corticosteroids).
- Achievement of clinical remission per Adapted Mayo score at Week 8.
- Achievement of clinical response per Adapted Mayo score at Week 8.
- Achievement of clinical response per Partial Adapted Mayo score at Week 8.
- Achievement of endoscopic remission at Week 8.
研究者
Global Clinial Trial Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
研究点 (12)
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