A Phase 3, 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 Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 418
- 试验地点
- 393
- 主要终点
- Percentage of Participants in Clinical Remission at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
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
- •Signed informed consent form
- •18 years of age or older
- •Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
- •Moderately to severely active UC as per the modified Mayo score
- •Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
排除标准
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
- •Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
- •Receiving prohibited medications and treatments
- •UC limited to the rectum only
- •Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
研究组 & 干预措施
Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
干预措施: Guselkumab Dose 3 (Drug)
Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
干预措施: Guselkumab Dose 1 (Drug)
Group 3: Placebo
Participants will receive matching placebo SC injection.
干预措施: Placebo (Other)
Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
干预措施: Guselkumab Dose 1 (Drug)
Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
干预措施: Guselkumab Dose 2 (Drug)
结局指标
主要结局
Percentage of Participants in Clinical Remission at Week 12
时间窗: Week 12
Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.
次要结局
- Percentage of Participants in Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants With Endoscopic Improvement at Week 12(Week 12)
- Percentage of Participants in Clinical Response at Week 12(Week 12)
- Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12(Week 12)
- Percentage of Participants in Clinical Remission at Week 24(Week 24)
- Percentage of Participants in Symptomatic Remission at Week 24(Week 24)
- Percentage of Participants With Endoscopic Improvement at Week 24(Week 24)
- Percentage of Participants in Clinical Response at Week 24(Week 24)