A Phase 2/3, Randomized, Double-blind, Placebo-and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 474
- 试验地点
- 52
- 主要终点
- Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
研究概览
简要总结
Phase 2:
- To evaluate the clinical efficacy of guselkumab in participants with Crohn's disease
- To evaluate the safety of guselkumab
Phase 3:
- To evaluate the clinical and endoscopic efficacy of guselkumab in participants with Crohn's disease
- To evaluate the safety of 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
- 是
入选标准
- •Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
- •Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- •Have screening laboratory test results within the protocol specified parameters
- •A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
- •Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
排除标准
- •Current diagnosis of ulcerative colitis or indeterminate colitis
- •Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
- •Unstable doses of concomitant Crohn's disease therapy
- •Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
- •Any medical contraindications preventing study participation
结局指标
主要结局
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12
Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response 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