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

NCT05222516 | Terminated Phase 2 DMC

• 1 other identifier: BV-2021/06
• Study Type: interventional
• Target: 63
• Locations: 4 countries
• Sites: 28

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.

Conditions

Atopic Dermatitis

Keywords

Moderate, Children

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 weeks

Secondary Outcomes (13)

• Frequency of flares

  32 Weeks

• Reduction of flares

  24 Weeks

• Change of flares

  24 Weeks

• Number of flares

  32 Weeks

• Disease severity treatment period

  24 weeks

Other Outcomes (8)

• Immunomodulatory effects of OM-85

  32 weeks

• Skin/gut microbiome

  32 weeks

• Correlation of microbiomes and outcomes

  32 weeks

Study Arms (2)

OM-85

EXPERIMENTAL

Daily administration of OM-85 (Broncho-Vaxom) 3.5 mg capsules

Drug: Broncho-Vaxom

Placebo

PLACEBO COMPARATOR

Daily administration of Placebo capsules

Drug: Placebo

Interventions

Broncho-Vaxom DRUG

Daily administration of Broncho-Vaxom 3.5mg capsules

Also known as: OM-85

OM-85

Placebo DRUG

Daily administration of Placebo capsules

Placebo

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• OM Pharma SA: lead

Study Sites (28)

Centre d'investigation clinique GHE

Bron, 69477, France

Location

CHU de Cote de Nacre, Centre de Recherche Clinique Pediatric

Caen, 14033, France

Location

Hopital Hotel Dieu

Nantes, 44035, France

Location

CHU de Nice

Nice, 06200, France

Location

CHU de Poitiers, L'unité de Dermatologie

Poitiers, 8600, France

Location

Mediopole Hopital Mutualiste

Villeurbanne, 69100, France

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, 21614, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Location

MENSINGDERMA research GmbH

Hamburg, 22391, Germany

Location

Kinderhautarztpraxis Dr. Marc Pleimes

Heidelberg, 69115, Germany

Location

Kinderarztpraxis Wirth

Krefeld, 47799, Germany

Location

Studienzentrum Dr. Beate Schwarz

Langenau, 89129, Germany

Location

Dermatologische Praxis Dr. Quist

Mainz, 55128, Germany

Location

Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin

Mainz, 55131, Germany

Location

Praxis Dr. Panzer

Mannheim, 68161, Germany

Location

Hautarztpraxis Burgstrasse

München, 80331, Germany

Location

Klinikum der Universität München

München, 80337, Germany

Location

Kinderpneumologische Praxis Dr. Funck

Neuss, 41469, Germany

Location

Kinderärztliche Gemeinschaftspraxis Bedikian und Bouikidis

Oberhausen, 46154, Germany

Location

Kinderarztpraxis Dres. Med. Sören Westerholt & Jan Matyas

Wolfsburg, 38448, Germany

Location

Erasmus MC University Department of Dermatology

Rotterdam, 3015 GD, Netherlands

Location

St. Franciscus Gasthuis & Vlietland Kindergeneeskunde

Rotterdam, 3045 PM, Netherlands

Location

Dermoklinika Centrum Medyczne

Lodz, 90-436, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Kliniczny Szpital Woiewodzki

Rzeszów, 35-055, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Lymphoma, Follicular

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Franziska Rueff, Professor

  Universitätsklinikum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Multicenter, randomized, double blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: OM-85 vs. placebo

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 3, 2022
• Study Start: December 20, 2021
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); NL (2); PL (3); DE (17)