Atopic Dermatitis MedDRA version: 20.0 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Broncho-Vaxom Kinder
Product Name: Broncho Vaxom
Product Code: OM-85
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral u
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of OM-85 versus matched placebo in children with moderate AD in reducing disease severity over the first 16 weeks and the first 24 weeks of the treatment period;Secondary Objective: •To assess the efficacy of OM-85 versus matched placebo in reducing flares over the treatment period and up to the end of the observational periods •To assess the efficacy of OM-85 versus matched placebo in children with moderate AD in reducing disease severity up to the end of the observational period •To evaluate the efficacy of OM-85 versus matched placebo in reducing the use of co-medications for the treatment of AD •To assess the efficacy of OM-85 versus matched placebo in reducing respiratory tract infections ((RTI) and wheezing episodes over the treatment period and up to the end of the observational period ;Primary end point(s): - Weekly area under the curve (AUC) of the EASI score from baseline to the latest evaluable assessment before or on week 16 visit, use of rescue medication, loss to follow-up or withdrawal of consent, whichever occurs first. - 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.;Timepoint(s) of evaluation of this end point: - Week 16 or latest evaluable assessment - Week 24 or latest evaluable assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Time to new AD flare, defined as = 50% worsening of Baseline EASI score or EASI score of > 21.0 (severe AD) from Baseline to end of the treatment period and the observational period 2 Percentage of patients free of flares from Baseline to the end of treatment period 3 Difference in free of flares days between treatment groups (placebo vs. verum) from Baseline to the end of treatment period 4 Number of new AD flares during the induction and maintenance period and during whole treatment and observational period 5 Weekly AUC of the EASI score from Baseline to the end of the treatment period 6 Weekly AUC of the EASI score from Baseline to the end of the observational period 7 EASI score change during the induction and maintenance period and during the whole treatment period and the observational period 8 SCORAD score change during the induction and maintenance period and during the whole treatment period and the observational period 9 vIGA-AD score change during the induction and maintenance period and during the whole treatment period and the observational period 10 Number and duration in days of TCS treatments for acute flares during the induction and maintenance period and during the whole treatment period and the observational period 11 Incidence of skin infections requiring systemic treatment and antibiotics during the induction and maintenance period and during the whole treatment period and the observational period 12 Number of respiratory tract infections and wheezing episodes during the induction and maintenance period and during the whole treatment period and during the observational period 13 ADCT score change during the induction and maintenance period and during the whole treatment period and the observational period ;Timepoint(s) of evaluation of this end point: End of the treatment period End of observational period | — |
Countries
France, Germany, Netherlands, Poland
Contacts
Public ContactProject leader
OM Pharma SA
Outcome results
None listed