A Phase 2 interventional study of AD17002 and Formulation buffer in Eosinophilic Asthma, sponsored by Advagene Biopharma Co. Ltd.. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Advagene Biopharma Co. Ltd. · Phase 2, Interventional, and Treatment
AD17002, an innate immune modulator, is likely to be effective as an add-on therapy to control poorly managed moderate to severe eosinophilic asthma.
101 studies on the registry are indexed under Pulmonary Eosinophilia; 23 are open to participants now.
This study's planned enrollment of 126 is above the median of 100 across 56 interventional studies indexed under Pulmonary Eosinophilia.
Browse Pulmonary Eosinophilia studies →Advagene Biopharma Co. Ltd. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who meet any of the following asthma criteria at the Screening visit:
Exclusion Criteria:
Formulation buffer
Other: Formulation buffer
containing 10 μg of AD17002
Biological: AD17002
containing 20 μg of AD17002
Biological: AD17002
The 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
The 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 frame: Baseline to week 17
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.
Time frame: Baseline to week 17
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.
Time frame: Baseline to week 17
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 frame: Baseline to week 17
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
Time frame: Baseline to week 17
Change in pre-bronchodilator (BD) FEV1
FEV1 (Forced Expiratory Volume in 1 Second) is measured using spirometry
Time frame: Baseline (Week 1) to Weeks 5, 9, 13, 15, and 17
Change in FeNO levels
Fractional Exhaled Nitric Oxide (FeNO) in a clinical trial is measured by an electrochemical FeNO analyzer.
Time frame: Baseline to week 17
Change in the ratio of weekly average PEF in the morning to predicted PEF from baseline
The predicted value of PEF equation: Men: PEFpred (L/min) = 3.89×Height (cm)-2.95×Age (years)+43.59 Women: PEFpred (L/min) = 4.10×Height (cm)-1.61×Age (years)-173.55 Ratio of PEF = measured weekly average PEF/PEFpred × 100
Time frame: Baseline to week 17
Change in asthma control
The ACT is a validated and patient-centric tool (questionnaire) that collects data directly from the patient regarding their symptoms, activity limitations, and medication use. A total of 5 questions. Each question is scored from 1 to 5, and the total is the sum of these scores, with a range of 5 to 25. A score of 19 or less suggests poorly controlled asthma.
Time frame: Baseline to week 17
Change in blood eosinophil counts
Measured Blood eosinophil counts (cells/μL)
Time frame: Baseline to week 17
change in vital signs
Number of participants with abnormal vital signs.
Time frame: Baseline to week 17
Change in laboratory values
Number of participants with abnormal laboratory test results
Time frame: Baseline to week 17
Change in percentage of sputum eosinophils
Measured eosinophil counts in the sputum
Time frame: Baseline to week 17
Change in serum levels of type 2 cytokines
Measured by an ELISA-based assay.
Time frame: Baseline to week 17
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Advagene Biopharma Co. Ltd.