Clinical trial NCT05222516: Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Moderate, Children
Lead sponsor: OM Pharma SA
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: OM-85 vs. placebo
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Disease severity
timeFrame: 16 weeks
measure: Disease severity
timeFrame: 24 weeks
Secondary outcomes:
measure: Frequency of flares
timeFrame: 32 Weeks
measure: Reduction of flares
timeFrame: 24 Weeks
measure: Change of flares
timeFrame: 24 Weeks
measure: Number of flares
timeFrame: 32 Weeks
measure: Disease severity treatment period
timeFrame: 24 weeks
measure: Disease severity observational
timeFrame: 32 weeks
measure: EASI change
timeFrame: 32 weeks
measure: Scorad change
timeFrame: 32 weeks
measure: vIGA-AD change
timeFrame: 32 weeks
measure: ADCT change
timeFrame: 32 weeks
measure: Co-medication use per patient
timeFrame: 32 weeks
measure: Skin infections and systemic treatment
timeFrame: 32 weeks
measure: Respiratory tract infections
timeFrame: 32 weeks
Other outcomes:
measure: Immunomodulatory effects of OM-85
timeFrame: 32 weeks
measure: Skin/gut microbiome
timeFrame: 32 weeks
measure: Correlation of microbiomes and outcomes
timeFrame: 32 weeks
measure: Correlation of gut microbiome and skin microbiome
timeFrame: 32 weeks
measure: Allergic sensitisation IgE
timeFrame: 32 weeks
measure: Allergic sensitisation biomarkers
timeFrame: 32 weeks
measure: OM-85 treatment-emergent adverse events and treatment-emergent serious adverse events
timeFrame: 32 weeks
measure: Skin/gut microbiome
timeFrame: 32 weeks
Locations:
city: Bron
country: France
facility: Centre d'investigation clinique GHE
city: Caen
country: France
facility: CHU de Cote de Nacre, Centre de Recherche Clinique Pediatric
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Nice
country: France
facility: CHU de Nice
city: Poitiers
country: France
facility: CHU de Poitiers, L'unité de Dermatologie
city: Villeurbanne Cedex
country: France
facility: Mediopole Hopital Mutualiste
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: MENSINGDERMA research GmbH
city: Heidelberg
country: Germany
facility: Kinderhautarztpraxis Dr. Marc Pleimes
city: Krefeld
country: Germany
facility: Kinderarztpraxis Wirth
city: Langenau
country: Germany
facility: Studienzentrum Dr. Beate Schwarz
city: Mainz
country: Germany
facility: Dermatologische Praxis Dr. Quist
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin
city: Mannheim
country: Germany
facility: Praxis Dr. Panzer
city: München
country: Germany
facility: Hautarztpraxis Burgstrasse
city: München
country: Germany
facility: Klinikum der Universität München
city: Neuss
country: Germany
facility: Kinderpneumologische Praxis Dr. Funck
city: Oberhausen
country: Germany
facility: Kinderärztliche Gemeinschaftspraxis Bedikian und Bouikidis
city: Wolfsburg
country: Germany
facility: Kinderarztpraxis Dres. Med. Sören Westerholt & Jan Matyas
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Department of Dermatology
city: Rotterdam
country: Netherlands
facility: St. Franciscus Gasthuis & Vlietland Kindergeneeskunde
city: Ostrowiec Świętokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Woiewodzki
city: Łódź
country: Poland
facility: Dermoklinika Centrum Medyczne
Study officials:
affiliation: Universitätsklinikum München
name: Franziska Rueff, Professor
role: PRINCIPAL_INVESTIGATOR
References: