2026-525923-26-00招募中3 期
A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 145
- 主要终点
- Clinical remission at Week 48
研究概览
简要总结
To evaluate the efficacy of JNJ-4804 at Week 48 compared with guselkumab
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
- •At the time of informed consent, be ≥18 years of age.
- •Diagnosis of UC established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
- •Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy.
- •An endoscopy subscore ≥2 as obtained during central review of the screening video endoscopy
- •Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies
排除标准
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn’s colitis or any findings suggestive of CD.
- •Isolated proctitis (UC limited to the rectum only or to <20 cm from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
- •Has a history of or ongoing chronic or recurrent infectious disease
- •Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
- •Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention
研究组 & 干预措施
JNJ-78934804
Test
干预措施: JNJ-78934804 (Drug)
Guselkumab
Comparator
干预措施: Guselkumab (Drug)
结局指标
主要结局
Clinical remission at Week 48
Clinical remission at Week 48
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 (145)
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