A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 506
- 主要终点
- Percentage of Participants who Achieve Endoscopic Remission
研究概览
简要总结
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants' body weight must be >= 40 kg at Baseline.
- •Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
- •CDAI >= 220 at Baseline.
- •Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
- •Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.
排除标准
- •Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
- •Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
- •Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
研究组 & 干预措施
Monotherapy: Risankizumab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.
干预措施: Risankizumab (Drug)
Combination Therapy: Risankizumab and Lutikizumab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.
干预措施: Lutikizumab (Drug)
Combination Therapy: Risankizumab and Lutikizumab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.
干预措施: Risankizumab (Drug)
Monotherapy: Lutikizumab
Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.
干预措施: Lutikizumab (Drug)
Long-Term Extension: Risankizumab Monotherapy
Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.
干预措施: Risankizumab (Drug)
Monotherapy: Trosunilimab
Participants will receive trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.
干预措施: Trosunilimab (Drug)
Combination Therapy: Risankizumab and Trosunilimab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.
干预措施: Trosunilimab (Drug)
Combination Therapy: Risankizumab and Trosunilimab
Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and trosunilimab Dose A as IV infusion and trosunilimab Dose B as SC injection.
干预措施: Risankizumab (Drug)
Monotherapy: ABBV-8736 - OUS Only
Participants will receive ABBV-8736 as IV infusion.
干预措施: ABBV-8736 (Drug)
结局指标
主要结局
Percentage of Participants who Achieve Endoscopic Remission
时间窗: Week 12
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Remission is defined as SES-CD ≤ 4 and no sub score greater than 1 in any individual variable, as scored by a central reader.
次要结局
- Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)(Week 12)
- Percentage of Participants who Achieve Endoscopic Response(Week 12)
- Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)(Week 12)
- Percentage of Participants who Achieve Endoscopic Response(Week 12)
- Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)(Week 12)
- Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI)(Week 12)