NCT03997786进行中（未招募）2 期
A Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 27
- 主要终点
- Part A - Dose determination for pediatrics population 6 to <12 year-old age group
研究概览
简要总结
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
The initial PK analysis is first done in adolescent subjects (12 to <18 years) before initiating the PK study in younger cohort (6 to <12 years)
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
- Single (Outcomes Assessor)
盲法说明
The study will follow three distinct components: Open-label PK, blinded Randomized Trial Component (RCT) with open-label comparator followed by the open-label extension.
入排标准
- 年龄范围
- 6 Years 至 215 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
- •Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
- •Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12
- •Subject must be considered a candidate for systemic therapy and/or phototherapy.
- •Subject is considered to be eligible according to tuberculosis (TB) screening criteria
- •A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.
排除标准
- •Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis
- •Subject has laboratory abnormalities at screening including any of the following: Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit of normal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5 mg/dL, white blood cell count < 3.0 x 103/μL, and any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
- •Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial
- •Female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (Sexually active adolescent girls will be required to use contraception)
- •Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening
- •Positive human immunodeficiency virus (HIV) test result, hepatitis B Virus (HBV) test results, or hepatitis C virus (HCV) test result
- •Subjects who have a high risk of suicidality at the Screening assessment as indicated by the C-SSRS (Columbia Suicide Severity Rating Scale), or based on the Investigator's judgment.
- •Subject who has received any of the prohibited medications, supplements or substances during the study.
研究组 & 干预措施
Part B 3: Efficacy and Safety Follow-up
No Intervention
Part A: Open-label PK and Safety: Part A
Active Comparator
Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component
干预措施: Tildrakizumab (Drug)
Part B- 1: Placebo and active comparator controlled study
Experimental
干预措施: Placebo (Drug)
Part B- 1: Placebo and active comparator controlled study
Experimental
干预措施: Tildrakizumab (Drug)
Part B- 1: Placebo and active comparator controlled study
Experimental
干预措施: Etanercept (Drug)
Part B-2: Randomized withdrawal and retreatment after relapse
Experimental
干预措施: Placebo (Drug)
Part B-2: Randomized withdrawal and retreatment after relapse
Experimental
干预措施: Tildrakizumab (Drug)
Part C: LTE
Experimental
干预措施: Tildrakizumab (Drug)
结局指标
主要结局
Part A - Dose determination for pediatrics population 6 to <12 year-old age group
时间窗: Up to week 16
Proportion of subjects with at least 75% improvement in the PASI response from baseline
时间窗: Week 16
Part A - Dose determination for pediatrics population 12 to <18-year-old age group
时间窗: Up to week 16
Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline
时间窗: Week 16
Number of subjects with adverse events
时间窗: Week 16
次要结局
- Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline(Week 12, 16, 28, 40, 52, 64, 76 and 88)
- Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline(Week 12, 16, 28, 40, 52, 64, 76 and 88)
- Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline(Week 12, 16, 28, 40, 52, 64, 76 and 88)
- Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)(Week 108)
- Percent of subjects with malignancies(Week 108)
- Number of subjects with adverse events(Week 52)
- Number of subjects with Adverse events(Week 108)
- Percent of subjects with severe infections(Week 108)
- Percent of subjects with confirmed major adverse cardiovascular events(Week 108)
- Percent of subjects with drug- related hypersensitivity reactions(Week 108)
- Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline(Week 16, 28, 40, 52, 64, 76 and 88)
- Immunogenicity - Anti-drug antibody status(Week 108)
研究者
研究点 (27)
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