Primary Objective Primary objective is 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.Secondary Objectives…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoints:
- Weekly area under the curve (AUC) of the EASI score from baseline up 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 up 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
- 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 to the end of the observational period
- Percentage of patients free of flares from Baseline to the end of treatment
period
- Difference in free of flares days between treatment groups (placebo vs.
verum) from Baseline to the end of treatment period
- 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
- Percentage of patients free of flares from Baseline to the end of treatment
period
- Difference in free of flares days between treatment groups (placebo vs.
verum) from Baseline to the end of treatment period
- Number of new AD flares during the induction and maintenance period and
during whole treatment and observational period
- Weekly AUC of the EASI score from Baseline to the end of the treatment period
- Weekly AUC of the EASI score from Baseline to the end of the observational
period
- EASI score change during the induction and maintenance period and during the
whole treatment period and the observational period
- SCORAD score change during the induction and maintenance period and during
the whole treatment period and the observational period
- vIGA-AD score change during the induction and maintenance period and during
the whole treatment period and the observational period
- ADCT score change during the induction and maintenance period and during the
whole treatment period and the observational period
- 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
- 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
- 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
Background summary
Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin condition with
prominent itching which occurs most frequently in children but also in adults.
AD affects up to 20% of children and 10% of adults in high-income countries. AD
starts in early childhood during the first 6 months of life in 45% of children,
in 60% during the first year of life and before the age of 5 years in at least
85% of affected individuals.
AD has a complex pathophysiology which includes a skewed response towards Th2
immunity, and defects in the innate immune system. The emergence of filaggrin
gene (FLG) as a risk allele for atopic disease also shifted weight on the role
of the skin barrier in AD pathogenesis. Although AD runs in families, it is
impossible to explain the increased prevalence of AD with genetics alone.
Factors predisposing to AD may be smaller family size, urban settings, and
Western diet, which affect both the skin and gut microbiota. The microbiome has
a well-documented role in AD. The crucial interaction between flora and humans
in AD is best presented through the hygiene hypothesis [4]. This theory
implicates that, in modern sanitized living conditions, there is reduced
microbial exposure early in life, which results in inadequate immune priming. A
normal child*s early microbiota has protective influence on the immune system
from allergic over-sensitization. In contrast, poor development or imbalance of
the microbiome early in life is known to affect the cutaneous immune response
in a way that children are predisposed to a number of immune conditions, such
as AD, with frequent secondary skin infections. Therefore, it is an approach to
use treatments based on the stimulation of the immune system by derivatives
mimicking the effect of bacteria, viruses or parasites as substitute for the
*protective* role of infections.
Study objective
Primary Objective
Primary objective is 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.
Secondary Objectives
Secondary objectives of the trial are:
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 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
Exploratory Objectives
Exploratory objectives of the trial are:
To explore the immunomodulatory effects of OM-85 versus matched placebo at the
skin and systemic level
To evaluate skin lesions and skin/gut microbiomes, incl. skin S. aureus
infections
To assess potential correlations between gut / skin microbiomes and primary
and/or secondary outcomes (e.g., EASI, SCORAD, vIGA-AD)
To explore potential correlations between gut microbiome and skin microbiome
To assess the effect of OM-85 versus matched placebo on allergic sensitisation
Safety Objectives
The safety objective is to assess the safety of OM-85 versus matched placebo in
early moderate paediatric AD
Study design
This is a Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa
trial
Intervention
One group receives study medication (OM-85; Broncho-Vaxom), one tablet daily,
the other group receives Placebo to OM-85, one tablet daily
Study burden and risks
This study benefits all children suffering from Atopic Dermatitis, as Atopic
Dermatitis affects up to 20% of children.
Participating children may receive an improvement of their Atopic Dermatitis.
The trial is designed in a way to keep the burden for participating children as
low as possible.
The medicinal product is on the market in several European countries for about
40 years and has proven to be safe in this time..
Rue du bois du Lan 22
Meyrin 2 Geneva 1217
CH
Rue du bois du Lan 22
Meyrin 2 Geneva 1217
CH
Listed location countries
Age
Inclusion criteria
1. Children of either gender, aged 3 to 24 months
2. Clinically confirmed diagnosis of AD of moderate severity documented by the
Investigator and lesions covering up to 30% of the body
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.
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 within 30 days before Baseline
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. Subject'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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003179-33-NL |
| ClinicalTrials.gov | NCT05222516 |
| CCMO | NL79068.078.22 |