An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
研究概览
简要总结
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
详细描述
A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active 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
- 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
- •Patient has active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points.
- •Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only).
排除标准
- •Patient who has previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other disease
- •Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product
- •Patient who has a current or past history of infection with HIV, hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled)
- •Patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug
- •Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at Screening, 1 retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
结局指标
主要结局
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
时间窗: Week 22, 24, 26 and 28
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
时间窗: Week 22
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
次要结局
- Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)(up to Week 54)
- Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)(up to Week 54)
- Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)(up to Week 54)
- Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)(up to Week 54)
- Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)(up to Week 54)
- Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)(up to Week 54)