About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AD17002
- Formulation buffer