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

NCT07250594 | Not Yet Recruiting Phase 2

• 1 other identifier: ADV-EASP212
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines.
2. 2.Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.
3. 3.AD17002 is an intranasal self-applicable immunomodulator.
4. 4.AD17002 is safe and tolerable in all studied clinical trials.
5. 5.AD17002 elevates local type-1 interferon levels and promotes epithelial healing.
6. 6.Type-1 interferons have been demonstrated to restore immune balance and reduce eosinophilic infiltration.

Conditions

Eosinophilic Asthma

Keywords

Eosinophile; Type 1 interferon; Type 2 cytokines; Immunomodulator; eosinophilic asthma; intranasal; self-applicable

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability endpoint

  The incidence and severity of TEAEs and serious TEAEs

  Baseline to week 17

Secondary Outcomes (11)

• Time to the first moderate and severe asthma exacerbations.

  Baseline to week 17

• Proportion of patients experiencing moderate and severe asthma exacerbations

  Baseline to week 17

• Number of moderate and severe asthma exacerbations

  Baseline to week 17

• Time to first asthma worsening alert.

  Baseline to week 17

• Change in pre-bronchodilator (BD) FEV1

  Baseline (Week 1) to Weeks 5, 9, 13, 15, and 17

Other Outcomes (2)

• Change in percentage of sputum eosinophils

  Baseline to week 17

• Change in serum levels of type 2 cytokines

  Baseline to week 17

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Formulation buffer

Other: Formulation buffer

Low dose (10 μg) AD17002

EXPERIMENTAL

containing 10 μg of AD17002

Biological: AD17002

High dose (20 μg) AD17002

EXPERIMENTAL

containing 20 μg of AD17002

Biological: AD17002

Interventions

AD17002 BIOLOGICAL

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

High dose (20 μg) AD17002; Low dose (10 μg) AD17002

Formulation buffer OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advagene Biopharma Co. Ltd.: lead

Study Sites (1)

Advagene Biopharma

Taipei, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Eosinophilia

Interventions

heat-labile enterotoxin, E coli

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Emily Lien, Master of Science

CONTACT

886-2-2797-0073; emily.lien@advagene.com.tw

Mingi Chang, Ph.D.

CONTACT

886-2-2797-0073; mingi.chang@advagene.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: November 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

TW (1)