NCT05222516

Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: OM Pharma SA · Industry
• Sex: All
• Age: 3 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Broncho-Vaxom	Daily administration of Broncho-Vaxom 3.5mg capsules
DRUG	Placebo	Daily administration of Placebo capsules

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-07-13
• Completion: 2023-07-13
• First posted: 2022-02-03
• Last updated: 2023-08-08

Locations

28 sites across 4 countries: France, Germany, Netherlands, Poland