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    Summary
    EudraCT Number:2021-003179-33
    Sponsor's Protocol Code Number:BV-2021/06
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-003179-33
    A.3Full title of the trial
    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 in children aged 3 to 24 months with early clinical diagnosis of moderate atopic dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of a marketed drug (OM-85) to evaluate reducing the severity of Atopic Dermatitis in small children
    A.4.1Sponsor's protocol code numberBV-2021/06
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOM Pharma SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOM Pharma
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOM Pharma SA
    B.5.2Functional name of contact pointProject leader
    B.5.3 Address:
    B.5.3.1Street AddressRue du Bois-du-Lan 22
    B.5.3.2Town/ cityMeyrin 2
    B.5.3.3Post code1217
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41227831459
    B.5.6E-mailLorenz.LEHR@ompharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Broncho-Vaxom Kinder
    D.2.1.1.2Name of the Marketing Authorisation holderOM Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBroncho Vaxom
    D.3.2Product code OM-85
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic Eczema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    •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
    E.2.3Trial contains a sub-study No
    E.3Principal 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 (<4 weeks prior to Screening/Baseline visit)
    documented by Investigator and pre-treated with TCS (within
    last 4 weeks prior to Screening/Baseline visit).
    3. AD onset no longer than 12 months before screening
    4. 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.
    E.4Principal 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)
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Week 16 or latest evaluable assessment
    - Week 24 or latest evaluable assessment
    E.5.2Secondary 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the treatment period
    End of observational period
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months28
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 120
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 120
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parents or Legal Representatives of the Children will give consent to study participation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After ending participation in the trial the patients will be treated by their physicians with Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-07-13
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