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.
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). The placebo will serve as reference in evaluating efficacy and safety of OM-85. The double blind, randomized trial design is selected to avoid bias concerning evaluation of the drug effects, including safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Daily administration of Broncho-Vaxom 3.5mg capsules
Daily administration of Placebo capsules
Disease severity
\- 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.
Time frame: 16 weeks
Disease severity
\- 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.
Time frame: 24 weeks
Frequency of flares
\- 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.
Time frame: 32 Weeks
Reduction of flares
\- Percentage of patients free of flares from Baseline to the end of treatment period
Time frame: 24 Weeks
Change of flares
\- Difference in free of flares days between treatment groups (placebo vs. verum) from Baseline to the end of treatment period
Time frame: 24 Weeks
Number of flares
\- Number of new AD flares during the induction and maintenance period and during the whole treatment and observational period
Time frame: 32 Weeks
Disease severity treatment period
\- Weekly AUC of the EASI score from Baseline to the end the treatment period
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Masking
QUADRUPLE
Enrollment
63
Centre d'investigation clinique GHE
Bron, France
CHU de Cote de Nacre, Centre de Recherche Clinique Pediatric
Caen, France
Hopital Hotel Dieu
Nantes, France
CHU de Nice
Nice, France
CHU de Poitiers, L'unité de Dermatologie
Poitiers, France
Mediopole Hopital Mutualiste
Villeurbanne, France
ISA - Interdisciplinary Study Association GmbH
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Elbe Klinikum Buxtehude
Buxtehude, Germany
Universitätsklinikum Dresden
Dresden, Germany
...and 18 more locations
Time frame: 24 weeks
Disease severity observational
\- Weekly AUC of the EASI score from Baseline to the end of the observational period
Time frame: 32 weeks
EASI change
\- EASI score change during the induction and maintenance period and during the whole treatment period and the observational period.
Time frame: 32 weeks
Scorad change
SCORAD score change during the induction and maintenance period and during the whole treatment period and the observational period
Time frame: 32 weeks
vIGA-AD change
\- vIGA-AD (Validated Investigator Global Assessment in Atopic Dermatitis) score change during the induction and maintenance period and during the whole treatment period and the observational period
Time frame: 32 weeks
ADCT change
\- ADCT score change during the induction and maintenance period and during the whole treatment period and the observational period
Time frame: 32 weeks
Co-medication use per patient
\- Number and duration in days of TCS (Topical Corticosteroids) treatments for acute flares during the induction and maintenance period and during the whole treatment period and the observational period
Time frame: 32 weeks
Skin infections and systemic treatment
\- 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
Time frame: 32 weeks
Respiratory tract infections
\- Number of respiratory tract infections and wheezing episodes during the induction and maintenance period and during the whole treatment period and the observational period
Time frame: 32 weeks