NCT02970331撤回2 期
A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)
研究概览
简要总结
A multi-center, open-label study that will evaluate the safety/tolerability and pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50 evaluable adolescents 12 to < 17 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or females 12 to < 17 years of age
- •Have a confirmed diagnosis of plaque psoriasis
- •Negative pregnancy test
- •Group 1: Have plaque psoriasis with an IGA score of ≥ 2 (mild), with at least one lesion ) and up to 20% Body Surface Area (BSA) involvement not including psoriasis on the face and scalp
- •Group 2: Have plaque psoriasis with a IGA score of ≥ 2 (mild), with plaque psoriasis involving at least 10% and up to 20% Body Surface Area (BSA) not including psoriasis on the face and scalp
排除标准
- •known allergy or intolerance to the study drug or other vitamin D3 analogs or any of its components
- •history of or active generalized guttate, pustular or erythrodermic exfoliative psoriasis
- •history or presence of contact dermatitis induced by a topical medicine or other serious skin condition that is not well controlled
- •Use topical treatments known to have beneficial effects on psoriasis
- •Use phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate within 30 days prior to the first dose of study drug
- •Use any approved biologics for psoriasis within 30 days or 5 half-lives of the biologic before the first dose of study drug
- •Are treated with medications known to worsen psoriasis
- •Are taking an oral vitamin D
- •Are taking medications that affect calcium metabolism;
- •Subjects who have an average of three (3) QTcF measurements of > 450 milliseconds as shown on the ECG (Group 2 only);
- •Have clinically significant abnormal calcium homeostasis parameters at Visit 1;
- •Have clinically significant liver or renal dysfunction
- •Have any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions which that would place the subject at increased risk or would confound the primary or secondary objectives of the study;
- •Use of any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of study drug or are taking part in a non-medication study which, that would interfere with study compliance or outcome assessments;
- •Are pregnant or lactating females;
- •Have a known history of congenital or acquired immunodeficiency.
研究组 & 干预措施
pefcalcitol
Experimental
pefcalcitol 0.005% BID for 8 weeks
干预措施: pefcalcitol ointment, 0.005% (Drug)
结局指标
主要结局
Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)
时间窗: week 8
Determination of plasma concentrations of Pefcalcitol and its metabolites
时间窗: Day 1 and Day 15
Change in incidence and severity of application site adverse events
时间窗: screening, weeks 0,2,4 and 8
Changes from baseline (pre-dose, Day 1) in safety laboratory parameters
时间窗: week 8
Change in incidence and severity of all AEs and their relationship to study drug
时间窗: screening, weeks 0,2,4 and 8
次要结局
- Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline(week 8)
- Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline(week 8)
- Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline(week 8)
- Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline(week 8)
研究者
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