[M23-703] A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AbbVie GK
- 入组人数
- 30
- 主要终点
- Percentage of Participants who Achieve Endoscopic Improvement
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant has had a diagnosis of Ulcerative Colitis (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.
- •Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) 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, immunomodulators, and/or advanced therapies.
排除标准
- •Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified.
- •Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- •Prior exposure to adalimumab (including biosimilars).
- •Note: Subject may be enrolled if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.
结局指标
主要结局
Percentage of Participants who Achieve Endoscopic Improvement
时间窗: Week 12
Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: - 0 = Normal appearance of mucosa - 1 = Mild disease (erythema, decreased vascular pattern) - 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions) - 3 = Severe disease (spontaneous bleeding, ulceration)
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately Week 64
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点