Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05222516
Recruitment Status : Recruiting
First Posted : February 3, 2022
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
OM Pharma

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Broncho-Vaxom Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: OM-85 vs. placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Multicenter, randomized, double blind, placebo controlled
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: OM-85
Daily administration of OM-85 (Broncho-Vaxom) 3.5 mg capsules
Drug: Broncho-Vaxom
Daily administration of Broncho-Vaxom 3.5mg capsules
Other Name: OM-85

Placebo Comparator: Placebo
Daily administration of Placebo capsules
Drug: Placebo
Daily administration of Placebo capsules




Primary Outcome Measures :
  1. Disease severity [ Time Frame: 16 weeks ]
    - 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.

  2. Disease severity [ Time Frame: 24 weeks ]
    - 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.


Secondary Outcome Measures :
  1. Frequency of flares [ Time Frame: 32 Weeks ]
    - 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. Reduction of flares [ Time Frame: 24 Weeks ]
    - Percentage of patients free of flares from Baseline to the end of treatment period

  3. Change of flares [ Time Frame: 24 Weeks ]
    - Difference in free of flares days between treatment groups (placebo vs. verum) from Baseline to the end of treatment period

  4. Number of flares [ Time Frame: 32 Weeks ]
    - Number of new AD flares during the induction and maintenance period and during the whole treatment and observational period

  5. Disease severity treatment period [ Time Frame: 24 weeks ]
    - Weekly AUC of the EASI score from Baseline to the end the treatment period

  6. Disease severity observational [ Time Frame: 32 weeks ]
    - Weekly AUC of the EASI score from Baseline to the end of the observational period

  7. EASI change [ Time Frame: 32 weeks ]
    - EASI score change during the induction and maintenance period and during the whole treatment period and the observational period.

  8. Scorad change [ Time Frame: 32 weeks ]
    SCORAD score change during the induction and maintenance period and during the whole treatment period and the observational period

  9. vIGA-AD change [ Time Frame: 32 weeks ]
    - 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

  10. ADCT change [ Time Frame: 32 weeks ]
    - ADCT score change during the induction and maintenance period and during the whole treatment period and the observational period

  11. Co-medication use per patient [ Time Frame: 32 weeks ]
    - 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

  12. Skin infections and systemic treatment [ Time Frame: 32 weeks ]
    - 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

  13. Respiratory tract infections [ Time Frame: 32 weeks ]
    - Number of respiratory tract infections and wheezing episodes during the induction and maintenance period and during the whole treatment period and the observational period


Other Outcome Measures:
  1. Immunomodulatory effects of OM-85 [ Time Frame: 32 weeks ]
    - Change of gut microbiome from Baseline to the end of the treatment period and to the observational period.

  2. Skin/gut microbiome [ Time Frame: 32 weeks ]
    - Change of skin microbiome during the induction and maintenance period and during the whole treatment period and the observational period, incl. S. Aureus infections.

  3. Correlation of microbiomes and outcomes [ Time Frame: 32 weeks ]
    - Potential correlations between gut microbiome data and primary and/or secondary outcomes (e.g., EASI, SCORAD, vIGA-AD).

  4. Correlation of gut microbiome and skin microbiome [ Time Frame: 32 weeks ]
    - Potential correlations between gut microbiome data and skin microbiome data (using diversity measures for the skin microbiome)

  5. Allergic sensitisation IgE [ Time Frame: 32 weeks ]
    - Change of total IgE ( Immunoglobulin E) and specific IgEs from Baseline to the end of the treatment period and the observational period

  6. Allergic sensitisation biomarkers [ Time Frame: 32 weeks ]
    - Change in expression of disease biomarkers in blood from Baseline to the end of the treatment period and the observational period.

  7. OM-85 treatment-emergent adverse events and treatment-emergent serious adverse events [ Time Frame: 32 weeks ]
    - Incidence of treatment-emergent adverse events and treatment-emergent serious adverse events from Baseline to the end of the observational period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children of either gender, aged 3 to 24 months
  • Clinically confirmed diagnosis of Atopic Dermatitis (according to Hanifin and Rajka) of moderate severity documented by the Investigator and lesions covering up to 30% of the body
  • Atopic Dermatitis onset no longer than 9 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).
  • Children with known allergy or previous intolerance/sensitivity to any of the trial treatments (IMP (Investigational Medicinal Product), AxMP(auxiliary Medicinal Product) 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.
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05222516


Contacts
Layout table for location contacts
Contact: Lorenz Lehr +41 22 783 14 59 lorenz.lehr@ompharma.com

Locations
Layout table for location information
Germany
Klinik für Kinder- und Jugendmedizin der Ruhr-Uni Bochum am Sankt Josef Hospital Not yet recruiting
Bochum, Germany, 44791
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53127
Elbe Klinikum Buxtehude Recruiting
Buxtehude, Germany, 21614
Universitätsklinikum Dresden Recruiting
Dresden, Germany, 01307
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79104
MENSINGDERMA research GmbH Recruiting
Hamburg, Germany, 22391
Kinderarztpraxis J.S. Iffland & Dr. Marinesse Recruiting
Hamburg, Germany, 22415
Kinderhautarztpraxis Dr. Marc Pleimes Recruiting
Heidelberg, Germany, 69115
Kinderarztpraxis Wirth Recruiting
Krefeld, Germany, 47799
Praxis Dr. Panzer Recruiting
Mannheim, Germany, 68161
Hautarztpraxis Burgstrasse Recruiting
München, Germany, 80331
Klinikum der Universität München Recruiting
München, Germany, 80337
Kinderpneumologische Praxis Dr. Funck Recruiting
Neuss, Germany, 41469
Kinderärztliche Gemeinschaftspraxis Bedikian und Bouikidis Recruiting
Oberhausen, Germany, 46154
Kinderarztpraxis Dres. Med. Sören Westerholt & Jan Matyas Recruiting
Wolfsburg, Germany, 38448
Sponsors and Collaborators
OM Pharma
Investigators
Layout table for investigator information
Principal Investigator: Franziska Rueff, Professor Universitätsklinikum München
Layout table for additonal information
Responsible Party: OM Pharma
ClinicalTrials.gov Identifier: NCT05222516    
Other Study ID Numbers: BV-2021/06
First Posted: February 3, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OM Pharma:
Moderate, Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs