Eosinophilic AsthmaPhase 2NCT07250594
A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma
A Phase 2 study testing AD17002 and Formulation buffer in people with Eosinophilic Asthma, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eosinophilic Asthma
- What is being tested?
- AD17002 and Formulation buffer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants who meet any of the following asthma criteria at the Screening visit:
- Moderate asthma-1 (i.e., step 3 in asthma treatment steps in adults and adolescents from 2025 GINA guideline):
- Moderate asthma-2 (i.e., step 4 in asthma treatment steps in adults and adolescents from 2025 GINA guideline):
- Severe asthma (i.e., step 5 in asthma treatment steps in adults and adolescents from 2025 GINA guideline, except for biologic therapies):
Who cannot join
- 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.
- With clinically severe lung disease, including but not limited to cystic fibrosis, chronic bronchitis (chronic obstructive pulmonary disease other than asthma), chronic respiratory infection, lung cancer, current infection, active tuberculosis infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema.
- With arrhythmia, myocardial infarction, or stroke within the last 3 months prior to the Screening visit.
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- With a recent respiratory tract infection within 4 weeks prior to the Screening visit.
- Received chronic oxygen therapy within one month prior to the Screening visit.
- With any nasal conditions that could interfere with drug absorption or confound the efficacy or safety assessments.
- Immunosuppressive treatment, including but not limited to methotrexate, troleandomycin, cyclosporine, and azathioprine within 3 months prior to the Screening visit and throughout the study.
- Use of systemic corticosteroids (including regular oral corticosteroids or intramuscular long-acting depot corticosteroids) at daily average doses greater than 7.5 mg prednisone or equivalent for the past 3 months prior to the Screening visit.
- Having or planning to be vaccinated with live (attenuated) vaccine within 1 month prior to the Screening visit and throughout the study.
- Having received immunotherapy including but not limited to monoclonal antibodies, within 3 months prior to the Screening visit and throughout the study.
- Having previously received AD17002.
- Having received other IP or investigational intervention (non-AD17002), including investigational formulations of marketed products, within the past 30 days or 5 half-lives of the medication, whichever is longer, prior to the Screening visit.
- Requiring add-on biologic therapy, such as anti-IgE, anti-IL-5/5R, anti-IL-4Rα, and anti-thymic stromal lymphopoietin treatment.
- Having experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with high-dose systemic corticosteroids (prednisolone ≥ 40 mg/day or equivalent for ≥ 5 days) within 1 month prior to the Screening visit.
- Having a history of anaphylaxis with cardiorespiratory symptoms, triggered by prior immunotherapy, an unknown cause, or an inhalant allergen.
- Being pregnant or breastfeeding.
- Planning to become pregnant or breastfeed throughout the study.
- A known history of allergy, hypersensitivity, or intolerance to any component of IP, rescue medications, or self-injectable epinephrine.
- Any clinically significant abnormalities in physical examination, vital signs, hematology, biochemistry, or urinalysis that, in the investigator's opinion, may pose a risk to the patient's safety, affect study outcomes, or hinder the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Advagene Biopharma
Taipei, Taiwan
Emily Lien Lien, Master of Science, 886-2-2797-0073, emily.lien@advagene.com.tw
About this study
Official title: A Phase II, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-dose Study to Investigate the Safety and Efficacy of 3-month AD17002 Treatment in Adults With Inadequately Controlled Moderate to Severe Eosinophilic Asthma
- Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines.
- Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.
- AD17002 is an intranasal self-applicable immunomodulator.
- AD17002 is safe and tolerable in all studied clinical trials.
- AD17002 elevates local type-1 interferon levels and promotes epithelial healing.
- 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.
- Conditions
- Eosinophilic Asthma
- Being tested
- AD17002, Formulation buffer
- Keywords
- Eosinophile, Type 1 interferon, Type 2 cytokines, Immunomodulator, eosinophilic asthma, intranasal, self-applicable
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD17002Biological
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
Formulation bufferOther
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Formulation buffer Receives: Other: Formulation buffer |
| Low dose (10 μg) AD17002 | Experimental | containing 10 μg of AD17002 Receives: Biological: AD17002 |
| High dose (20 μg) AD17002 | Experimental | containing 20 μg of AD17002 Receives: Biological: AD17002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability endpoint
The incidence and severity of TEAEs and serious TEAEs
Measured: Baseline to week 17
Secondary outcomes (11)
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.
- Nocturnal awakening(s) for 2 consecutive nights
- Daily asthma symptom score Increases ≥ 0.75 from baseline on 2 consecutive days
- Increase the use of rescue medication on 2 consecutive days (applicable only when minimum increase: 4 puffs/day)
- ≥ 20% decrease in peak expiratory flow (PEF) from baseline on at least 2 consecutive mornings and evenings
- Visit to the outpatient department for exacerbation of asthma
- ≥ 20% decrease in FEV1 from baseline.
Severe exacerbation of asthma is defined by any of the following:
- Use of systemic corticosteroids, or an increase in the current maintenance dose of oral corticosteroids (OCS), for at least 3 consecutive days.
- Emergency department visit, hospitalization, or treatment with systemic corticosteroids due to an acute asthma event.
Measured: 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.
- Nocturnal awakening(s) for 2 consecutive nights
- Daily asthma symptom score Increases ≥ 0.75 from baseline on 2 consecutive days
- Increase the use of rescue medication on 2 consecutive days (applicable only when minimum increase: 4 puffs/day)
- ≥ 20% decrease in peak expiratory flow (PEF) from baseline on at least 2 consecutive mornings and evenings
- Visit to the outpatient department for exacerbation of asthma
- ≥ 20% decrease in FEV1 from baseline.
Severe exacerbation of asthma is defined by any of the following:
- Use of systemic corticosteroids, or an increase in the current maintenance dose of oral corticosteroids (OCS), for at least 3 consecutive days.
- Emergency department visit, hospitalization, or treatment with systemic corticosteroids due to an acute asthma event.
Measured: 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.
- Nocturnal awakening(s) for 2 consecutive nights
- Daily asthma symptom score Increases ≥ 0.75 from baseline on 2 consecutive days
- Increase the use of rescue medication on 2 consecutive days (applicable only when minimum increase: 4 puffs/day)
- ≥ 20% decrease in peak expiratory flow (PEF) from baseline on at least 2 consecutive mornings and evenings
- Visit to the outpatient department for exacerbation of asthma
- ≥ 20% decrease in FEV1 from baseline.
Severe exacerbation of asthma is defined by any of the following:
- Use of systemic corticosteroids, or an increase in the current maintenance dose of oral corticosteroids (OCS), for at least 3 consecutive days.
- Emergency department visit, hospitalization, or treatment with systemic corticosteroids due to an acute asthma event.
Measured: Baseline to week 17
Time to first asthma worsening alert.
Asthma worsening alert is defined as any one of the following criteria:
- Nocturnal awakening(s) and requiring rescue medication for 2 consecutive nights
- Daily symptom score increase of ≥ 0.75 from baseline on 2 consecutive days
- Rescue medicine increases from baseline on 2 consecutive days (applicable only when minimum increase: 4 puffs/day)
- ≥ 20% decrease in PEF from baseline on at least 2 consecutive mornings and evenings
- Outpatient visit for exacerbation of asthma not requiring systemic corticosteroids
- ≥ 20% decrease in FEV1 from baseline
Measured: Baseline to week 17
Change in pre-bronchodilator (BD) FEV1
FEV1 (Forced Expiratory Volume in 1 Second) is measured using spirometry
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to week 17
Change in blood eosinophil counts
Measured Blood eosinophil counts (cells/μL)
Measured: Baseline to week 17
change in vital signs
Number of participants with abnormal vital signs.
Measured: Baseline to week 17
Change in laboratory values
Number of participants with abnormal laboratory test results
Measured: Baseline to week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advagene Biopharma Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250594
- Sponsor's protocol ID
- ADV-EASP212
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-dose Study to Investigate the Safety and Efficacy of 3-month AD17002 Treatment in Adults With Inadequately Controlled Moderate to Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT07250594
- Acronym / sponsor ID
- ADV-EASP212
- Conditions
- Eosinophilic Asthma
- Keywords
- Eosinophile, Type 1 interferon, Type 2 cytokines, Immunomodulator, eosinophilic asthma, intranasal, self-applicable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Advagene Biopharma Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (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.
- Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines.
- Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.
- AD17002 is an intranasal self-applicable immunomodulator.
- AD17002 is safe and tolerable in all studied clinical trials.
- AD17002 elevates local type-1 interferon levels and promotes epithelial healing.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Formulation bufferFormulation buffer |
| Low dose (10 μg) AD17002 | Experimental | Biological: AD17002containing 10 μg of AD17002 |
| High dose (20 μg) AD17002 | Experimental | Biological: AD17002containing 20 μg of AD17002 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Participants who meet any of the following asthma criteria at the Screening visit:
Key exclusion criteria (22 listed)
- 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.
- With clinically severe lung disease, including but not limited to cystic fibrosis, chronic bronchitis (chronic obstructive pulmonary disease other than asthma), chronic respiratory infection, lung cancer, current infection, active tuberculosis infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema.
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 |
|---|---|---|
| AD17002The 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 | Biological | High dose (20 μg) AD17002, Low dose (10 μg) AD17002 |
| Formulation bufferThe 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 | Other | Placebo |
Primary outcome
Safety and tolerability endpoint
Time frame: Baseline to week 17
The incidence and severity of TEAEs and serious TEAEs
11 secondary outcomes
Time to the first moderate and severe asthma exacerbations.
Time frame: Baseline to week 17
Proportion of patients experiencing moderate and severe asthma exacerbations
Time frame: Baseline to week 17
Number of moderate and severe asthma exacerbations
Time frame: Baseline to week 17
Time to first asthma worsening alert.
Time frame: Baseline to week 17
Change in pre-bronchodilator (BD) FEV1
Time frame: Baseline (Week 1) to Weeks 5, 9, 13, 15, and 17
Change in FeNO levels
Time frame: Baseline to week 17
Change in the ratio of weekly average PEF in the morning to predicted PEF from baseline
Time frame: Baseline to week 17
Change in asthma control
Time frame: Baseline to week 17
Change in blood eosinophil counts
Time frame: Baseline to week 17
change in vital signs
Time frame: Baseline to week 17
Change in laboratory values
Time frame: Baseline to week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD17002 and Formulation buffer in people with Eosinophilic Asthma, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.
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 8 inclusion and 22 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: opening soon, as of the sponsor's last update on 26 Nov 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Lien, Master of Science (886-2-2797-0073, emily.lien@advagene.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability endpoint (time frame: Baseline to week 17). 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 26 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.