2023-504719-34-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 143
- 试验地点
- 31
- 主要终点
- Clinical remission (at week 12)
研究概览
简要总结
To evaluate the efficacy, including clinical remission, of guselkumab SC induction compared to placebo in participants with moderately to severely active UC
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
- 是
入选标准
- •Documented diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline.
- •Moderately to severely active UC as assessed by the modified mayo score
- •Demonstraed inadequate response to or intolerance of conventional (ie, 6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).
排除标准
- •1.Has severe extensive colitis as defined in the protocol
- •2.Extent of inflammatory disease limited to the rectum
- •3.Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
- •4.Has a history of, or ongoing, chronic or recurrent infectious disease
- •5.Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 weeks prior to first dose of study intervention)
结局指标
主要结局
Clinical remission (at week 12)
Clinical remission (at week 12)
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (31)
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