A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 931
- 试验地点
- 475
- 主要终点
- US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
- •Diagnosis of CD for at least 3 months prior to Baseline.
- •Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
- •Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
- •If female, participant must meet the contraception recommendations.
排除标准
- •Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- •Participants with unstable doses of concomitant Crohn's disease therapy.
- •Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
- •Prior exposure to p19 inhibitors (e.g., risankizumab).
- •Complications of Crohn's disease.
- •Having an ostomy or ileoanal pouch.
- •Known active Coronavirus Disease 2019 (COVID-19) infection.
研究组 & 干预措施
Risankizumab Dose 1 (Period 1)
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
干预措施: risankizumab IV (Drug)
Risankizumab Dose 2 (Period 1)
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
干预措施: risankizumab IV (Drug)
Placebo (Period 1)
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
干预措施: placebo for risankizumab (Drug)
Risankizumab Dose 1 (Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
干预措施: risankizumab IV (Drug)
Risankizumab Dose 2 (Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
干预措施: risankizumab SC (Drug)
Risankizumab Dose 3 (Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
干预措施: risankizumab SC (Drug)
结局指标
主要结局
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
时间窗: Week 12
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Global Outside of US: Percentage of Participants With Clinical Remission
时间窗: Week 12
Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Global Outside of US: Percentage of Participants With Endoscopic Response
时间窗: Week 12
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
US Specific: Percentage of Participants With Endoscopic Response
时间窗: Week 12
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
次要结局
- US Specific: Percentage of Participants With Clinical Remission(Week 12)
- US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline(Week 12)
- US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission(Week 4)
- US Specific: Percentage of Participants With Stool Frequency (SF) Remission(Week 12)
- Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue(Week 12)
- Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment(Week 12)
- Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission(Week 12)
- US Specific: Percentage of Participants With Endoscopic Remission(Week 12)
- US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at(Week 12)
- US Specific: Percentage of Participants With CD-Related Hospitalization(Week 12)
- US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response(Week 12)
- US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue(Week 12)
- US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response(Week 12)
- US Specific: Percentage of Participants With Abdominal Pain (AP) Remission(Week 12)
- US Specific: Percentage of Participants With Enhanced Clinical Response(Week 12)
- Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response(Week 12)
- US Specific: Percentage of Participants With Ulcer-Free Endoscopy(Week 12)
- Global Outside of US: Percentage of Participants With Clinical Remission(Week 4)
- Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score(Week 12)
- Global Outside of US: Percentage of Participants With Enhanced Clinical Response(Week 12)
- Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy(Week 12)
- Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline(Week 12)
- Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline(Week 12)
- Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response(Week 12)
- Global Outside of US: Percentage of Participants With Endoscopic Remission(Week 12)
- Global Outside of US: Percentage of Participants With CD-Related Hospitalization(Week 12)
- Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score(Week 12)