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 Children Aged 3 to 24 Months With Early Clinical Diagnosis of Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- OM Pharma SA
- 入组人数
- 63
- 试验地点
- 28
- 主要终点
- Disease severity
研究概览
简要总结
Clinical data suggest that treatment with OM-85, by inducing an early contact with bacterial extracts, could modulate the immunity of children with Atopic Dermatitis, and thus play an active role in the treatment of Atopic Dermatitis.
The present trial will investigate the influence of administration of OM-85 in the paediatric population younger than 24 months with moderate atopic dermatitis.
The efficacy and safety of OM-85 will be evaluated in children aged 3 to 24 months old with moderate Atopic Dermatitis who may benefit from treatment with OM-85. The placebo treatment period will serve as a reference and has been added to establish efficacy and safety.
详细描述
In this study, the efficacy of OM-85 versus matched placebo in children with moderate AD (Atopic Dermatitis) in reducing disease severity shall be evaluated.
Clinical data suggest that treatment with OM-85, by inducing an early contact with bacterial extracts, could modulate the immunity of children with AD, and thus play an active role in the treatment of AD.
This will be a multicenter, randomised, double-blind, placebo-controlled exploratory phase IIa trial to assess the efficacy and safety of daily oral administration of OM-85 or matched placebo in children aged 3 to 24 months for 24 weeks.
A total of 142 children with AD as defined by Hanifin and Rajka criteria and with moderate disease severity (EASI 7.1 - 21.0) at Screening will be enrolled into this trial in approximately 15 sites in Germany and potentially one additional European country. All screened subjects will receive a unique subject ID (Identification) number.
Eligible subjects will be randomized at 1:1 ratio, stratified by age (≤12 months vs. >12 months) and disease severity (EASI <16 vs. ≥16) to one of the two treatments. They will receive either OM-85 or placebo for a 24-week treatment period followed by an observational period of 8 weeks without investigational medicinal products (IMP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Multicenter, randomized, double blind, placebo controlled
入排标准
- 年龄范围
- 3 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender, aged 3 to 24 months
- •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).
- •Atopic Dermatitis onset no longer than 12 months before Screening
- •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.
排除标准
- •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.
- •Specifically, any inflammatory skin conditions that are considered during the differential diagnosis of atopic dermatitis: allergic contact dermatitis, dermatographism, psoriasis, pityriasis alba.
- •Any chronic diseases (other than wheezing and asthmatic bronchitis) that require the administration of systemic corticosteroids (e.g., eosinophilic esophagitis) or immunosuppressant agents.
- •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).
- •Infants and children with known allergy or previous intolerance/sensitivity to any of the trial treatments (IMP, AxMP or standardized emollient) to be administered.
- •Use of systemic drugs interfering with the immune system (e.g. corticosteroids, immunosuppressants) within 30 days before Baseline (with exception of routine vaccinations)
- •Previous or ongoing treatment with other bacterial lysates and/or probiotics within 30 days before Baseline
- •Use of systemic antibiotics within 30 days before Baseline
- •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)
- •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.
- •Subject's families expected to relocate out of study area during the duration of the study.
- •Other household members have previously been randomised in this clinical study.
- •Previous participation to this study.
- •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)
研究组 & 干预措施
OM-85
Daily administration of OM-85 (Broncho-Vaxom) 3.5 mg capsules
干预措施: Broncho-Vaxom (Drug)
Placebo
Daily administration of Placebo capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Disease severity
时间窗: 24 weeks
- Weekly area under the curve (AUC) of the EASI score from baseline to the latest evaluable assessment before or on week 24 visit, use of rescue medication, loss to follow-up or withdrawal of consent, whichever occurs first.
次要结局
- Reduction of flares(24 Weeks)
- Change of flares(24 Weeks)
- ADCT change(32 weeks)
- Skin infections and systemic treatment(32 weeks)
- Respiratory tract infections(32 weeks)
- Number of flares(32 Weeks)
- Scorad change(32 weeks)
- vIGA-AD change(32 weeks)
- Disease severity treatment period(24 weeks)
- Disease severity observational(32 weeks)
- EASI change(32 weeks)
- Frequency of flares(32 Weeks)
- Co-medication use per patient(32 weeks)