Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 64
- 主要终点
- Plasma concentrations of Certolizumab pegol (CZP) at Week 16
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
- •Body Surface Area (BSA) affected by psoriasis ≥10 %
- •Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
- •Psoriasis Area and Severity Index (PASI) score is ≥12 or
- •PASI score is ≥10 and <12 with at least one of the following:
- •>Clinically relevant facial or scalp involvement
- •>Clinically relevant genital involvement
- •>Clinically relevant palm and sole involvement
- •>Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with >50 % to <80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
- •Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
排除标准
- •Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
- •Study participant has generalized pustular or erythrodermic psoriasis (PSO)
- •Study participant has guttate PSO without plaque PSO
- •Study participant has had a primary failure to an anti-tumor necrosis factor agent
- •Study participant has had prior exposure to >2 biologic therapies
- •Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening
研究组 & 干预措施
Cohort A - placebo
Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period.
干预措施: Placebo (Drug)
Cohort A - certolizumab pegol
Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Active Treatment period and through the subsequent Open-Label Extension Period.
干预措施: Certolizumab pegol (Drug)
Cohort A - placebo
Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period.
干预措施: Certolizumab pegol (Drug)
Cohort B - certolizumab pegol - Open-label
Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period.
干预措施: Certolizumab pegol (Drug)
结局指标
主要结局
Plasma concentrations of Certolizumab pegol (CZP) at Week 16
时间窗: Week 16
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 16.
Plasma anti-CZP antibody titers at Week 16
时间窗: Week 16
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 16.
Plasma concentrations of CZP at Week 52
时间窗: Week 52
Blood samples will be collected for measurement of plasma concentrations of CZP at Week 52.
Plasma anti-CZP antibody titers at Week 52
时间窗: Week 52
Blood samples will be collected for measurement of anti-CZP antibody titers at Week 52.
次要结局
- Incidence of serious treatment emergent adverse events(From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years))
- Incidence of treatment emergent adverse events leading to withdrawal(From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years))
- Incidence of serious treatment emergent adverse events(From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years))
- Incidence of treatment emergent adverse events leading to withdrawal(From Baseline until participant reaches 18 years of age or Cimzia becomes commercially available for pediatric PSO in participant's region (up to 12 years))