A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Eosinophilic Asthma
• Intervention / Treatment: Other: Formulation buffer; Biological: AD17002

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Emily Lien, Master of Science; Phone Number: 886-2-2797-0073; Email: emily.lien@advagene.com.tw
• Study Contact Backup: Name: Mingi Chang, Ph.D.; Phone Number: 886-2-2797-0073; Email: mingi.chang@advagene.com.tw

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan
      • Advagene Biopharma
      • Contact: Emily Lien Lien, Master of Science; Phone Number: 886-2-2797-0073; Email: emily.lien@advagene.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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):

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Formulation buffer	Other: Formulation buffer; 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
Experimental: Low dose (10 μg) AD17002; containing 10 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
Experimental: High dose (20 μg) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability endpoint	The incidence and severity of TEAEs and serious TEAEs	Baseline to week 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	Baseline to week 17
Change in pre-bronchodilator (BD) FEV1	FEV1 (Forced Expiratory Volume in 1 Second) is measured using spirometry	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.	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	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.	Baseline to week 17
Change in blood eosinophil counts	Measured Blood eosinophil counts (cells/μL)	Baseline to week 17
change in vital signs	Number of participants with abnormal vital signs.	Baseline to week 17
Change in laboratory values	Number of participants with abnormal laboratory test results	Baseline to week 17

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percentage of sputum eosinophils	Measured eosinophil counts in the sputum	Baseline to week 17
Change in serum levels of type 2 cytokines	Measured by an ELISA-based assay.	Baseline to week 17

Collaborators and Investigators

• Sponsor: Advagene Biopharma Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 4, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Immunomodulator; intranasal; eosinophilic asthma; Type 1 interferon; Eosinophile; Type 2 cytokines; self-applicable
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pulmonary Eosinophilia; heat-labile enterotoxin, E coli
• Other Study ID Numbers: ADV-EASP212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No