2026-525922-39-00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 Crohn’s Disease
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
- 194
- 试验地点
- 126
- 主要终点
- Clinical remission at Week 48 Endoscopic 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（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •At the time of informed consent, must be ≥18 years of age
- •Have a diagnosis of CD established ≥12 weeks by both endoscopic evidence and a histopathology report.
- •Have moderately to severely active CD defined as a baseline CDAI score ≥220 but ≤450 in addition to a mean daily stool frequency count ≥4.0 or a mean daily abdominal pain score ≥2.0
- •Have a screening Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥6 (or ≥4 for participants with isolated ileal disease).
- •Have an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
排除标准
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, UC or clinical findings highly suggestive of UC.
- •Has a history of short bowel syndrome, is missing >2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to assess efficacy.
- •Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab.
- •Is a participant who is pregnant, or 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
Guselkumab
Comparator
干预措施: Guselkumab (Drug)
JNJ-78934804
Test
干预措施: JNJ-78934804 (Drug)
结局指标
主要结局
Clinical remission at Week 48 Endoscopic remission at Week 48
Clinical remission at Week 48 Endoscopic 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 (126)
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