jRCT2031220309进行中（未招募）不适用
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease (DUET-CD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 715
- 主要终点
- Percentage of Participants with Clinical Remission at Week 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- •Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- •Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease
- •If female and of childbearing potential, must meet the contraception and reproduction requirements
排除标准
- •Complications of CD that may be anticipated to require surgery
- •Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- •Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
- •Has a draining (example, functioning) stoma or ostomy
- •Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention)
- •Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
结局指标
主要结局
Percentage of Participants with Clinical Remission at Week 48
时间窗: Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 48
时间窗: Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD),as assessed by central endoscopy reading.
次要结局
- Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48(Week 48)
- Percentage of Participants with Endoscopic Remission at Week 48(Week 48)
- Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48(Week 48)
- Percentage of Participants with Clinical Remission at Week 48(Week 48)
- Percentage of Participants with Endoscopic Response at Week 48(Week 48)
- Percentage of Participants with Adverse Events (AEs)(Up to Week 48)
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 48)
- Clinical Laboratory Parameters Over Time(Up to Week 48)
- Vital Sign Parameters Over Time(Up to Week 48)
- Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score(Up to Week 48)
- Serum Concentrations of Guselkumab Over Time(Up to Week 48)
- Serum Concentrations of Golimumab Over Time(Up to Week 48)
- Percentage of Participants with Antibodies to Guselkumab(Up to Week 48)
- Titers of Antibodies to Guselkumab(Up to Week 48)
- Percentage of Participants with Antibodies to Golimumab(Up to Week 48)
- Titers of Antibodies to Golimumab(Up to Week 48)
- Percentage of Participants with Neutralizing Antibodies to Guselkumab(Up to Week 48)
- Percentage of Participants with Neutralizing Antibodies to Golimumab(Up to Week 48)
研究者
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