EUCTR2021-003179-33-NL进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa trial to investigate the efficacy of OM-85 versus matched placebo in reducing disease severity in children aged 3 to 24 months with early clinical diagnosis of moderate atopic dermatitis
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
- OM Pharma SA
- 入组人数
- 120
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
- 性别
- All
入选标准
- •1. Children of either gender, aged 3 to 24 months
- •2. Patients with a clinically confirmed diagnosis of AD (according to Hanifin and Rajka) of moderate severity (EASI 7.1 – 21.0) and lesions covering up to 30% of the body either
- •-assessed by Investigator at the screening/baseline visit
- •- or recently (<4 weeks prior to screening/Baseline visit) documented by Investigator and pre-
- •treated with TCS (within last 4 weeks prior to Screening/Baseline visit).
- •3. AD onset no longer than 12 months before screening
- •4. Legally acceptable representatives (i.e. parent(s) or guardians) of subject according to local regulations have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including Screening procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •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
- •1. Any diseases that may be considered as the differential diagnosis of atopic dermatitis, and notably skin infections and infestations (e.g. scabies), other inflammatory skin conditions, dermatological malignancies, dermatological genetic diseases such as immunodeficiency conditions, and nutritional disorders with cutaneous manifestations and drug eruptions.
- •2. Specifically, any inflammatory skin conditions that are considered during the differential diagnosis of atopic dermatitis: allergic contact dermatitis, dermatographism, psoriasis, pityriasis alba.
- •3. Any chronic diseases (other than wheezing, Atopic Dermatitis and asthmatic bronchitis) that require the administration of topical and/or systemic corticosteroids (e.g., eosinophilic esophagitis) or immunosuppressant agents.
- •4. Significant medical condition(s), which, in the Investigator’s opinion, are anticipated to require major surgery during the study, or any other type of disorder that might involve an increased risk to the subject, could interfere with study assessments or outcomes, or the ability of parents to comply with the study procedures (e.g. eDiary).
- •5. Children with known allergy or previous intolerance/sensitivity to any of the trial treatments (IMP, AxMP or standardized emollient) to be administered.
- •6. Use of systemic drugs interfering with the immune system (e.g. corticosteroids, immunosuppressants) within 30 days before Baseline (with exception of routine vaccinations)
- •7. Previous or ongoing treatment with other bacterial lysates and/or probiotics (dietary supplements, medicinal products and/or other health products) within 30 days before Baseline (Note: previous use of probiotics is allowed, if the use is medically justified and had no impact on AD severity)
- •8. Use of systemic antibiotics within 30 days before Baseline
- •9. Participation in any other investigational trial on a medical device or medicinal product <30 days prior to Baseline or any previous participation in a study involving bacterial lysates and/or probiotics, or current treatment with other investigational agent(s)
- •10. Any major surgery within the last 3 months prior to Baseline, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
- •11. Subject's families expected to relocate out of study area during the duration
- •of the study.
- •12. Other household members have previously been randomised in this clinical study.
- •13. Previous participation to this study.
- •14. Close affiliation of subject or parents with the investigational site; e.g. a close relative of the Investigator, dependent person (e.g. employee or student of the investigational site)
研究者
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