EUCTR2018-000349-38-ES进行中（未招募）1 期
I4V-MC-JAIP A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis - BREEZE-AD-PEDS
illy S.A.0 个研究点目标入组 465 人开始时间: 2019年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 465
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months (if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
- •- Have a documented history by a physician and/or investigator of inadequate response to OR history of intolerance to topical corticosteroids (TCS) AND topical calcineurin inhibitors (TCNI).
- •- Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
- •- Agree to use emollients daily
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 465
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
- •- A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
- •- Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
- •- Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
- •- Have been treated with the following therapies:
- •Monoclonal antibody for less than 5 half-lives prior to randomization.
- •Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- •Received any parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
- •- Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
- •- Have high blood pressure characterized by a repeated systolic blood pressure >95th percentile based on age, sex and height.
- •- Have had major surgery within the past eight weeks or are planning major surgery during the study.
- •- Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- •- Have a history of VTE or are considered at high risk of VTE as deemed by the investigator.
- •- Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- •- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster (shingles or chicken pox), tuberculosis.
- •- Have specific laboratory abnormalities.
- •- Have received certain treatments that are contraindicated.
- •- Pregnant or breastfeeding.
研究者
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