Atopic DermatitisPhase 2NCT05222516
Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD
A Phase 2 study testing Broncho-Vaxom in people with Atopic Dermatitis, run by OM Pharma SA at 28 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Broncho-Vaxom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 28 sitesin 4 countries
- Study dates
- 20 Dec 2021to 13 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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)
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
Germany17 sites
ISA - Interdisciplinary Study Association GmbH
Berlin, 10789
Universitätsklinikum Bonn
Bonn, 53127
Elbe Klinikum Buxtehude
Buxtehude, 21614
Universitätsklinikum Dresden
Dresden, 01307
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79104
MENSINGDERMA research GmbH
Hamburg, 22391
Kinderhautarztpraxis Dr. Marc Pleimes
Heidelberg, 69115
Kinderarztpraxis Wirth
Krefeld, 47799
Studienzentrum Dr. Beate Schwarz
Langenau, 89129
Dermatologische Praxis Dr. Quist
Mainz, 55128
Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin
Mainz, 55131
Praxis Dr. Panzer
Mannheim, 68161
Hautarztpraxis Burgstrasse
München, 80331
Klinikum der Universität München
München, 80337
Kinderpneumologische Praxis Dr. Funck
Neuss, 41469
Kinderärztliche Gemeinschaftspraxis Bedikian und Bouikidis
Oberhausen, 46154
Kinderarztpraxis Dres. Med. Sören Westerholt & Jan Matyas
Wolfsburg, 38448
France6 sites
Centre d'investigation clinique GHE
Bron, 69477
CHU de Cote de Nacre, Centre de Recherche Clinique Pediatric
Caen, 14033
Hopital Hotel Dieu
Nantes, 44035
CHU de Nice
Nice, 06200
CHU de Poitiers, L'unité de Dermatologie
Poitiers, 8600
Mediopole Hopital Mutualiste
Villeurbanne, 69100
Poland3 sites
Dermoklinika Centrum Medyczne
Lodz, 90-436
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, 27-400
Kliniczny Szpital Woiewodzki
Rzeszów, 35-055
Netherlands2 sites
Erasmus MC University Department of Dermatology
Rotterdam, 3015 GD
St. Franciscus Gasthuis & Vlietland Kindergeneeskunde
Rotterdam, 3045 PM
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Broncho-Vaxom, Placebo
- Keywords
- Moderate, Children
- Medical subject headings
- Dermatitis, Atopic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho-VaxomDrug
Also called OM-85
Daily administration of Broncho-Vaxom 3.5mg capsules
PlaceboDrug
Daily administration of Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| OM-85 | Experimental | Daily administration of OM-85 (Broncho-Vaxom) 3.5 mg capsules Receives: Drug: Broncho-Vaxom |
| Placebo | Placebo comparator | Daily administration of Placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Secondary outcomes (13)
Frequency of flares
- 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.
Measured: 32 Weeks
Reduction of flares
- Percentage of patients free of flares from Baseline to the end of treatment period
Measured: 24 Weeks
Change of flares
- Difference in free of flares days between treatment groups (placebo vs. verum) from Baseline to the end of treatment period
Measured: 24 Weeks
Number of flares
- Number of new AD flares during the induction and maintenance period and during the whole treatment and observational period
Measured: 32 Weeks
Disease severity treatment period
- Weekly AUC of the EASI score from Baseline to the end the treatment period
Measured: 24 weeks
Disease severity observational
- Weekly AUC of the EASI score from Baseline to the end of the observational period
Measured: 32 weeks
EASI change
- EASI score change during the induction and maintenance period and during the whole treatment period and the observational period.
Measured: 32 weeks
Scorad change
SCORAD score change during the induction and maintenance period and during the whole treatment period and the observational period
Measured: 32 weeks
vIGA-AD change
- 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
Measured: 32 weeks
ADCT change
- ADCT score change during the induction and maintenance period and during the whole treatment period and the observational period
Measured: 32 weeks
Co-medication use per patient
- 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
Measured: 32 weeks
Skin infections and systemic treatment
- 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
Measured: 32 weeks
Respiratory tract infections
- Number of respiratory tract infections and wheezing episodes during the induction and maintenance period and during the whole treatment period and the observational period
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start20 Dec 2021
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Why it stopped: Recommendation of DSMB (futility of Endpoints)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- OM-85 vs. placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- OM Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franziska Rueff, Professor, Principal investigator, Universitätsklinikum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222516
- Sponsor's protocol ID
- BV-2021/06
- Status last verified
- Apr 2023
- First submitted
- 22 Dec 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Go N, Arsene S, Faddeenkov I, Galland T, Martis B S, Lefaudeux D, Wang Y, Etheve L, Jacob E, Monteiro C, Bosley J, Sansone C, Pasquali C, Lehr L, Kulesza A. A quantitative systems pharmacology workflow toward optimal design and biomarker stratification of atopic dermatitis clinical trials. J Allergy Clin Immunol. 2024 May;153(5):1330-1343. doi: 10.1016/j.jaci.2023.12.031. Epub 2024 Feb 16.
PubMed 38369029
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05222516
- Acronym / sponsor ID
- BV-2021/06
- Conditions
- Atopic Dermatitis
- Keywords
- Moderate, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recommendation of DSMB (futility of Endpoints)
- Enrolment
- 63 participants (actual)
- Lead sponsor
- OM Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- OM-85 vs. placebo
| Arm | Type | Receives |
|---|---|---|
| OM-85 | Experimental | Drug: Broncho-VaxomDaily administration of OM-85 (Broncho-Vaxom) 3.5 mg capsules |
| Placebo | Placebo comparator | Drug: PlaceboDaily administration of Placebo capsules |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho-VaxomAlso: OM-85Daily administration of Broncho-Vaxom 3.5mg capsules | Drug | OM-85 |
| PlaceboDaily administration of Placebo capsules | Drug | Placebo |
Primary outcome
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.
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.
13 secondary outcomes
Frequency of flares
Time frame: 32 Weeks
Reduction of flares
Time frame: 24 Weeks
Change of flares
Time frame: 24 Weeks
Number of flares
Time frame: 32 Weeks
Disease severity treatment period
Time frame: 24 weeks
Disease severity observational
Time frame: 32 weeks
EASI change
Time frame: 32 weeks
Scorad change
Time frame: 32 weeks
vIGA-AD change
Time frame: 32 weeks
ADCT change
Time frame: 32 weeks
Co-medication use per patient
Time frame: 32 weeks
Skin infections and systemic treatment
Time frame: 32 weeks
Respiratory tract infections
Time frame: 32 weeks
Results and safety
The study was stopped early (reason given: Recommendation of DSMB (futility of Endpoints)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 38369029Go N, Arsene S, Faddeenkov I, Galland T, Martis B S, Lefaudeux D, Wang Y, Etheve L, Jacob E, Monteiro C, Bosley J, Sansone C, Pasquali C, Lehr L, Kulesza A. A quantitative systems pharmacology workflow toward optimal design and biomarker stratification of atopic dermatitis clinical trials. J Allergy Clin Immunol. 2024 May;153(5):1330-1343. doi: 10.1016/j.jaci.2023.12.031. Epub 2024 Feb 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franziska Rueff, Professor principal investigator
Universitätsklinikum München
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Broncho-Vaxom in people with Atopic Dermatitis, run by OM Pharma SA at 28 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, France, Poland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recommendation of DSMB (futility of Endpoints)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease severity (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05222516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.