1. Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines. 2. Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction. 3. AD17002 is an intranasal self-applicable immunomodulator. 4. AD17002 is safe and tolerable in all studied clinical trials. 5. AD17002 elevates local type-1 interferon levels and promotes epithelial healing. 6. Type-1 interferons have been demonstrated to restore immune balance and reduce eosinophilic infiltration.
AD17002, an innate immune modulator, is likely to be effective as an add-on therapy to control poorly managed moderate to severe eosinophilic asthma.
Aged 18 to 80 on the day of signing the informed consent.
With a diagnosis of asthma for at least 6 months.
With pre-BD FEV1 ≥ 50% of the predicted value at the Screening visit (see section 18.6 for calculation of the predicted value for FEV1).
Having blood eosinophil counts ≥ 150 cells/μL at the Screening visit.
A current smoker or quit smoking ≤ 0.5 years at Screening visit.
With serious underlying chronic illness or severe systemic disease, including but not limited to systemic lupus erythematosus, at the investigator's discretion.
With a current malignancy or previous history of cancer in remission for less than 5 years prior to Screening visit (Subject will not be excluded if he/she had localized carcinoma of the skin that was resected for cure).
With chronic heart failure in New York Heart Association class III to IV.
Parallel
AD17002
Biological/VaccineThe IP, AD17002, will be provided in a container, each containing an appropriate number of IP pre-filled, self-administered syringes. Each container will be labeled as required per local requirements
Formulation buffer
Other interventionThe placebo will be provided in a container, each containing an appropriate volume of formulation buffer, pre-filled syringes for self-administration. Each container will be labeled as required per local requirements
Safety and tolerability endpoint
The incidence and severity of TEAEs and serious TEAEs
Time to the first moderate and severe asthma exacerbations.
Exacerbation of asthma as defined below: Moderate exacerbation of asthma is defined as meeting any one of the following criteria. 1. Nocturnal awakening(s) for 2 consecutive nights 2. Daily asthma symptom score Increases ≥ 0.75 from baseline on 2 consecutive days 3. Increase the use of rescue medication on 2 consecutive days (applicable only when minimum increase: 4 puffs/day) 4. ≥ 20% decrease in peak expiratory flow (PEF) from baseline on at least 2 consecutive mornings and evenings 5. Visit to the outpatient department for exacerbation of asthma 6. ≥ 20% decrease in FEV1 from baseline. Severe exacerbation of asthma is defined by any of the following: 1. Use of systemic corticosteroids, or an increase in the current maintenance dose of oral corticosteroids (OCS), for at least 3 consecutive days. 2. Emergency department visit, hospitalization, or treatment with systemic corticosteroids due to an acute asthma event.
Proportion of patients experiencing moderate and severe asthma exacerbations
Exacerbation of asthma as defined below: Moderate exacerbation of asthma is defined as meeting any one of the following criteria. 1. Nocturnal awakening(s) for 2 consecutive nights 2. Daily asthma symptom score Increases ≥ 0.75 from baseline on 2 consecutive days 3. Increase the use of rescue medication on 2 consecutive days (applicable only when minimum increase: 4 puffs/day) 4. ≥ 20% decrease in peak expiratory flow (PEF) from baseline on at least 2 consecutive mornings and evenings 5. Visit to the outpatient department for exacerbation of asthma 6. ≥ 20% decrease in FEV1 from baseline. Severe exacerbation of asthma is defined by any of the following: 1. Use of systemic corticosteroids, or an increase in the current maintenance dose of oral corticosteroids (OCS), for at least 3 consecutive days. 2. Emergency department visit, hospitalization, or treatment with systemic corticosteroids due to an acute asthma event.
Number of moderate and severe asthma exacerbations
Exacerbation of asthma as defined below: Moderate exacerbation of asthma is defined as meeting any one of the following criteria. 1. Nocturnal awakening(s) for 2 consecutive nights 2. Daily asthma symptom score Increases ≥ 0.75 from baseline on 2 consecutive days 3. Increase the use of rescue medication on 2 consecutive days (applicable only when minimum increase: 4 puffs/day) 4. ≥ 20% decrease in peak expiratory flow (PEF) from baseline on at least 2 consecutive mornings and evenings 5. Visit to the outpatient department for exacerbation of asthma 6. ≥ 20% decrease in FEV1 from baseline. Severe exacerbation of asthma is defined by any of the following: 1. Use of systemic corticosteroids, or an increase in the current maintenance dose of oral corticosteroids (OCS), for at least 3 consecutive days. 2. Emergency department visit, hospitalization, or treatment with systemic corticosteroids due to an acute asthma event.
Time to first asthma worsening alert.
Asthma worsening alert is defined as any one of the following criteria: 1. Nocturnal awakening(s) and requiring rescue medication for 2 consecutive nights 2. Daily symptom score increase of ≥ 0.75 from baseline on 2 consecutive days 3. Rescue medicine increases from baseline on 2 consecutive days (applicable only when minimum increase: 4 puffs/day) 4. ≥ 20% decrease in PEF from baseline on at least 2 consecutive mornings and evenings 5. Outpatient visit for exacerbation of asthma not requiring systemic corticosteroids 6. ≥ 20% decrease in FEV1 from baseline
Change in percentage of sputum eosinophils
Measured eosinophil counts in the sputum
Change in serum levels of type 2 cytokines
Measured by an ELISA-based assay.
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