Allergic AsthmaPhase 1NCT06486662
A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients
A Phase 1 study testing OM-85-IN in people with Allergic Asthma, run by OM Pharma SA at 1 site in Germany.
Trial summary
This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- OM-85-IN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jun 2024to 19 Feb 2025
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects aged 18 to 55 years. Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test, and not breastfeeding.
- Of non-childbearing potential, or
- Of childbearing potential and using a highly effective method of contraception .
- Body mass index (BMI) ≥18 and ≤32 kg/m2.
- Part II : History of mild asthma that is well controlled with Step 1 treatment according to GINA guidelines 2023 for at least 12 months prior to the Screening Visit, i.e., a history of respiratory symptoms such as wheeze, shortness of breath, chest tightness, cough, and limitation of airflow induced by aeroallergens.
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- Part II: Forced Expiratory Volume in the first second (FEV1) ≥80% of predicted at Screening Visit.
- Part II : Positive skin prick test to common aeroallergens such as tree, weed, grass or house dust mites within 12 months prior to the Screening Visit
- Part II : Production of adequate sputum with ≥2 x 105 total non-squamous cells within 12 months to 2 weeks prior to V1A (Day -8)
- Part II : Positive reaction to Nasal Allergen Challenge (NAC) within 12 months to 2 weeks prior to baseline
Who cannot join
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function or electrocardiogram (ECG) at Screening Visit, which, in the opinion of the Investigator, may either put the subject at risk because ofvparticipation in the study or may influence the results of the study, or the subject's ability to participate in the study."
- Use of prohibited medication prior to study enrolment
- Part II - Long-term, daily treatment with inhaled corticosteroids.
- Part II - Exacerbation of asthma defined according to the GINA guideline 2023 as a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e., they represent a change from the patient's usual status that is sufficient to require treatment changes within 1 month prior to the Screening Visit.
- Part II - Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active during study participation.
- Known allergy to IMP active substance and/or excipients or the challenge agent components.
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- Specific immunotherapy in the past 3 years before Baseline, ongoing treatment with any specific immunotherapy or plan to receive such treatment during study participation.
- 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.
- Patients with pathological skin modifications in the test area (e.g., acute or chronic eczema or skin infections), with disturbed skin reactivity (e.g., hyperkeratosis, ichthyosis, urticaria factitial), or with acute, generalized hypersensitivity reactions.
- Participation in any other clinical study within 30 days prior to Screening.
- Past or present disease, which as judged by the Investigator, may affect the outcome of this study.
- Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies, hepatitis C virus antibodies (HCV-Ab) or human immunodeficiency virus (HIV) antibody at Screening Visit
- History or presence of clinically significant hypertension
- History of anaphylactic shock, generalised exanthema, angioedema or hypotension caused by the allergen used for NAC, or any medicinal product in the past.
- History of drug or alcohol abuse in the past 12 months.
- Current smokers or ex-smokers for less than 6 months or more than 10 pack years. Current vapers (users of e-cigarette products) or ex-vapers for less than 6 months.
- Part II : Negative reaction in the baseline NAC
Trial locations and contacts
1 site in 1 country.
Germany1 site
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
Hanover, 30625
About this study
Official title: Safety, Tolerability and Pharmacodynamics of Single and Multiple Ascending Doses of OM-85-IN Versus Placebo in Healthy Volunteers, and Patients With Mild Allergic Asthma Using Nasal Allergen Challenge
This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
Read the detailed description
This study is a double-blind, randomised, placebo-controlled, single and multiple ascending doses, parallel group design study that aims to assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
- Conditions
- Allergic Asthma
- Being tested
- OM-85-IN, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM-85-INDrug
Participants will receive a Single Ascending Dose (SAD): 1 day single dose treatment and Multiple Ascending Doses (MAD): 16 days multiple dose treatment of OM-85-IN
PlaceboDrug
Participants will receive a Single Ascending Dose (SAD): 1 day single dose treatment and Multiple Ascending Doses (MAD): 16 days multiple dose treatment of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part I -Cohort 1 | Experimental | OM-85-IN low Dose Receives: Drug: OM-85-IN |
| Part I -Cohort 1 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part I -Cohort 2 | Experimental | OM-85-IN medium dose Receives: Drug: OM-85-IN |
| Part I -Cohort 2 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part I -Cohort 3 | Experimental | OM-85-IN high dose Receives: Drug: OM-85-IN |
| Part I -Cohort 3 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part II -Cohort 4 | Experimental | OM-85-IN dose Receives: Drug: OM-85-IN |
| Part II -Cohort 4 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection)
Measured: 28 days
Secondary outcomes (6)
Part II : Mean difference of Total Nasal Symptom Score (TNSS points) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC
Measured: 28 days
Part II : Area under the curve (AUC)0-6 hours of Total Nasal Symptom Score (TNSS points) after NAC before and after treatment
Measured: 28 days
Part II : Mean difference of nasal flow by rhinomanometry (Pascal) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC
Measured: 28 days
Part II : Area under the curve (AUC)0-6 of nasal flow by rhinomanometry (Pascal) after NAC before and after treatment
Measured: 28 days
Part II : Mean difference in fractional exhaled nitric oxide (FeNO) before and after treatment and NAC
Measured: 28 days
Part II : Mean difference on mannitol dose resulting in ≥15% fall in FEV1 from baseline or ≥10% incremental fall in FEV1 between consecutive mannitol doses after NAC before and after treatment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Jun 2024
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- OM Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486662
- Sponsor's protocol ID
- BV-2022/11
- Other IDs
- 2022-503053-19-00
- Status last verified
- Feb 2025
- First submitted
- 20 Jun 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacodynamics of Single and Multiple Ascending Doses of OM-85-IN Versus Placebo in Healthy Volunteers, and Patients With Mild Allergic Asthma Using Nasal Allergen Challenge
- ClinicalTrials.gov ID
- NCT06486662
- Acronym / sponsor ID
- BV-2022/11
- Conditions
- Allergic Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- OM Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 3 Jul 2024 (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.
This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
Detailed description
This study is a double-blind, randomised, placebo-controlled, single and multiple ascending doses, parallel group design study that aims to assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part I -Cohort 1 | Experimental | Drug: OM-85-INOM-85-IN low Dose |
| Part I -Cohort 1 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part I -Cohort 2 | Experimental | Drug: OM-85-INOM-85-IN medium dose |
| Part I -Cohort 2 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part I -Cohort 3 | Experimental | Drug: OM-85-INOM-85-IN high dose |
| Part I -Cohort 3 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part II -Cohort 4 | Experimental | Drug: OM-85-INOM-85-IN dose |
| Part II -Cohort 4 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and female subjects aged 18 to 55 years. Women will be considered for inclusion if they are:
- Body mass index (BMI) ≥18 and ≤32 kg/m2.
- Part II : History of mild asthma that is well controlled with Step 1 treatment according to GINA guidelines 2023 for at least 12 months prior to the Screening Visit, i.e., a history of respiratory symptoms such as wheeze, shortness of breath, chest tightness, cough, and limitation of airflow induced by aeroallergens.
- Part II: Forced Expiratory Volume in the first second (FEV1) ≥80% of predicted at Screening Visit.
- Part II : Positive skin prick test to common aeroallergens such as tree, weed, grass or house dust mites within 12 months prior to the Screening Visit
Key exclusion criteria (17 listed)
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, lung function or electrocardiogram (ECG) at Screening Visit, which, in the opinion of the Investigator, may either put the subject at risk because ofvparticipation in the study or may influence the results of the study, or the subject's ability to participate in the study."
- Use of prohibited medication prior to study enrolment
- Part II - Long-term, daily treatment with inhaled corticosteroids.
- Part II - Exacerbation of asthma defined according to the GINA guideline 2023 as a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e., they represent a change from the patient's usual status that is sufficient to require treatment changes within 1 month prior to the Screening Visit.
- Part II - Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active during study participation.
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 |
|---|---|---|
| OM-85-INParticipants will receive a Single Ascending Dose (SAD): 1 day single dose treatment and Multiple Ascending Doses (MAD): 16 days multiple dose treatment of OM-85-IN | Drug | Part I -Cohort 1, Part I -Cohort 2, Part I -Cohort 3, Part II -Cohort 4 |
| PlaceboParticipants will receive a Single Ascending Dose (SAD): 1 day single dose treatment and Multiple Ascending Doses (MAD): 16 days multiple dose treatment of Placebo | Drug | Part I -Cohort 1 Placebo, Part I -Cohort 2 Placebo, Part I -Cohort 3 Placebo, Part II -Cohort 4 Placebo |
Primary outcome
Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection)
Time frame: 28 days
6 secondary outcomes
Part II : Mean difference of Total Nasal Symptom Score (TNSS points) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC
Time frame: 28 days
Part II : Area under the curve (AUC)0-6 hours of Total Nasal Symptom Score (TNSS points) after NAC before and after treatment
Time frame: 28 days
Part II : Mean difference of nasal flow by rhinomanometry (Pascal) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC
Time frame: 28 days
Part II : Area under the curve (AUC)0-6 of nasal flow by rhinomanometry (Pascal) after NAC before and after treatment
Time frame: 28 days
Part II : Mean difference in fractional exhaled nitric oxide (FeNO) before and after treatment and NAC
Time frame: 28 days
Part II : Mean difference on mannitol dose resulting in ≥15% fall in FEV1 from baseline or ≥10% incremental fall in FEV1 between consecutive mannitol doses after NAC before and after treatment
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OM-85-IN in people with Allergic Asthma, run by OM Pharma SA at 1 site in Germany.
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.