A prospective, randomized, phase III open-label clinical trial with blinded end-point assessment to evaluate the efficacy and safety of cyclosporine and methotrexate in children and adolescent subjects with moderate-to-severe atopic dermatitis. - STEADY: Systemic Treatment Efficacy in Atopic Dermatitis in Young children and adolescents.

Medical University of Lodz0 个研究点目标入组 317 人2020年11月12日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Medical University of Lodz
入组人数: 317
状态: 进行中（未招募）
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年11月12日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Medical University of Lodz

入排标准

入选标准

•\-At the moment of giving written informed consent the patient is between 2\-18 y.o.;
•\-Diagnosis of moderate or severe AD established at least 6 months before baseline. Moderate\-to\-severe AD (EASI\>16, BSA\>10, SCORAD\>25\) must be confirmed based on clinical features on the screening and baseline visits;
•\-The patient, according to doctor’s opinion is a candidate for systemic therapy;
•\-Body weight of the participant is within 3 and 97 percentile grid, matched for sex and age;
•\-Female and male participants may be included. The participants who reached sexual maturity must be willing and give permission to use contraceptives or, together with the parent(s)/legal guardian(s), give a written agreement on sexual abstinence for the whole duration of clinical trial and within 6 months after cessation of IMP. In females with childbearing potential (defined as Tanner stage \=3 or menarche), a pregnancy test must be performed at screening and baseline visit to rule out pregnancy. Pregnancy tests will be performed according to schedule (see below for further information);
•\-The patient can use only topical emollients within 2 weeks before administration of the first study treatment dose;
•\-The participant, parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, treatment plan, laboratory test and other study procedures;
•\-The participant, parent(s)/legal guardian(s) give permission to avoid excessive exposure to natural or artificial sunlight (solaria) during the course of clinical trial;
•\-The medications taken by the participants for other indications than AD must be in stable doses within 2 weeks or 5 half\-lives (whichever is longer) prior to the screening visit;
•\-The participant, parent(s)/legal guardian(s) must be willing and give permission to use only one emollient during the clinical trial, provided by the Sponsor;

排除标准

•\-The participant suffers from any acute or chronic disease or has abnormal laboratory tests results which could increase the risk of the trial medical intervention and which, according to the Investigator’s opinion, could interfere with the treatment and obscure the interpretation of the results or which make the subject otherwise ineligible to take part in the clinical trial;
•\-The presence of any psychiatric disorder, alcohol abuse, drug dependency in the participant or in the participant’s parent(s)/legal guardian(s), which in the Investigator’s opinion may make them unable to take part in the clinical trial and to comply with the trial protocol;
•\-Current clinically significant infection or a history of a clinically significant infection, including herpes simplex infection within 3 months prior to baseline visit which, in the opinion of the Investigator or sponsor’s medical expert, may compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject’s ability to participate in the trial. Clinically significant infections are defined as: a systemic infection and/or a serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication;
•\-History of any active skin infection within 1 week prior to baseline visit;
•\-Positive test for HIV;
•\-Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (anti\-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb;
•\-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \=2\.0 times the upper limit of normal (ULN) at screening;
•\-Immune disorders which may, in the opinion of the Investigator, compromise the safety of the subject in the trial or interfere with evaluation of the IMP;
•\-Active or latent tuberculosis or improperly treated tuberculosis, proven with QuantiFERON TB Gold test performed on the screening visit or within 12 weeks before the baseline visit. Successful chemoprophylaxis in accordance with local guidelines may enable re\-screening;
•\-Immunosuppressive treatment or use of systemic steroids within 4 weeks before the first dose of IMP;