EUCTR2021-003179-33-DE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 and asthmatic bronchitis) that require the administration of 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. Participant'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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