A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission at Week 12
研究概览
简要总结
This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active 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)
盲法说明
Period 1 was blinded intravenous (IV) therapy, period 2 was open label IV therapy and period 3 was open label subcutaneous (SC) therapy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Double-blind Placebo IV
Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: risankizumab IV (Drug)
Double-blind Placebo IV
Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: risankizumab SC (Drug)
Double-blind Placebo IV
Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: Placebo (Drug)
Double-blind Risankizumab 200 mg IV
Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: risankizumab IV (Drug)
Double-blind Risankizumab 200 mg IV
Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: risankizumab SC (Drug)
Double-blind Risankizumab 600 mg IV
Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: risankizumab IV (Drug)
Double-blind Risankizumab 600 mg IV
Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
干预措施: risankizumab SC (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission at Week 12
时间窗: Week 12
The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: \< 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and \> 450 indicates severely active disease. CDAI clinical remission is defined as CDAI \< 150 at Week 12. Nonresponder imputation (NRI): missing values were counted as nonresponders.
次要结局
- Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission at Week 12(Week 12)
- Percentage of Participants Achieving Deep Remission at Week 12(Week 12)
- Percentage of Participants Achieving Mucosal Healing at Week 12(Week 12)
- Percentage of Participants Achieving CDAI Clinical Response at Week 12(Week 12)
- Percentage of Participants Achieving CDEIS Response at Week 12(Week 12)