EUCTR2009-014368-20-SE
进行中（未招募）
不适用
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of AdolescentSubjects With Moderate to Severe Plaque-type Psoriasis - CADMUS
适应症Moderate to Severe Plaque-type PsoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
相关药物STELARA
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Moderate to Severe Plaque-type Psoriasis
- 发起方
- Janssen-Cilag International N.V.
- 入组人数
- 150
- 状态
- 进行中（未招募）
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Boys or girls \= 12 and \< 18 years of age.
- •Have a diagnosis of plaque\-type psoriasis with or without PsA for at least 6 months
- •prior to first administration of study agent, with widespread lesions defined by
- •PASI \= 12, PGA \= 3, and involved BSA \= 10%.
- •Are candidates for phototherapy or systemic treatment of psoriasis (either naive or
- •history of previous treatment) or have psoriasis considered by the investigator as
- •poorly controlled with topical therapy after an adequate dose and duration of
- •Girls must be either:
- •\- Premenarchal or,
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from
- •participating in the study:
- •Currently have nonplaque forms of psoriasis (eg, erythrodermic, guttate, or
- •Have current drug\-induced psoriasis (eg, a new onset of psoriasis or an
- •exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
- •Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled
- •in the study or within 15 weeks after receiving the last administration of study
- •Have used any therapeutic agent targeted at reducing IL\-12 or IL\-23, including but
- •not limited to ustekinumab and briakinumab.
- •Have used topical medications/treatments that could affect psoriasis or PASI
结局指标
主要结局
未指定
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