CNTO1959CRD3004: A 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 Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 348
- 主要终点
- Percentage of Participants Who Achieved Clinical Remission at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn's disease (CD) of at least 3 months in duration
- •Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
- •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
- •Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
- •Unstable doses of concomitant Crohn's disease therapy
研究组 & 干预措施
Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
干预措施: Guselkumab Dose 3 (Drug)
Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
干预措施: Guselkumab Dose 2 (Drug)
Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
干预措施: Guselkumab Dose 1 (Drug)
Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
干预措施: Guselkumab Dose 1 (Drug)
Group 3: Placebo
Participants will receive placebo injection subcutaneously.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Remission at Week 12
时间窗: At Week 12
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score \<150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) and a decrease in total CDAI score over time indicates improvement in disease activity.
Percentage of Participants Who Achieved Endoscopic Response at Week 12
时间窗: At Week 12
Percentage of participants who achieved endoscopic response at Week 12 were reported. Endoscopic response was defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluated 4 endoscopic components (presence and size of ulcer, extent of ulcerated surface, extent of affected surface, and presence and type of narrowing) across 5 ileocolonic segments (ileum, right colon, transverse colon, left colon, and rectum), each scored from 0 (best) to 3 (worst) for each segment except narrowing component for which the maximum total score (that is, stricturing) was 11 points. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.
次要结局
- Percentage of Participants Who Achieved Clinical Remission at Week 24(At Week 24)
- Percentage of Participants Who Achieved Patient-reported Outcome (PRO)-2 Remission at Week 12(At Week 12)
- Percentage of Participants Who Achieved Clinical Response at Week 12(At Week 12)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 48(Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48)
- Percentage of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 48(Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Leading to Discontinuation of Study Drug Through Week 48(Placebo, Guselkumab 400 mg + 100 mg, and Guselkumab 400 mg + 200 mg: From Week 0 up to Week 48; Placebo arm subset - Rescue Treatment: From Week 16 up to Week 48)