2023-504743-13-00招募中2 期
A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 383
- 试验地点
- 128
- 主要终点
- Clinical remission at Week 48 compared with each monotherapy
研究概览
简要总结
To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed 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
- •Demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy (ADT) for IBD that includes biologics as well as oral small molecule therapies with biologic-like effects
- •If female and of childbearing potential, must meet the contraception and reproduction requirements
排除标准
- •Has severe extensive colitis as defined in the protocol
- •Extent of inflammatory disease limited to the rectum
- •Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
- •Has a history of, or ongoing, chronic or recurrent infectious disease
- •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 months of first dose of study intervention)
结局指标
主要结局
Clinical remission at Week 48 compared with each monotherapy
Clinical remission at Week 48 compared with each monotherapy
次要结局
未报告次要终点
研究者
Clinical Registry Groupp
Scientific
Janssen - Cilag International
研究点 (128)
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