AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma

NCT05985694 | Completed Phase 1

• 1 other identifier: ADV_Asthma_17002-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it seeks to answer are

1. 1.Could the AD17002 intranasal immunomodulator improve the clinical condition of eosinophilic asthmatic patients?
2. 2.Could patients self-administer AD17002 via the intranasal route?
3. 3.Is the AD17002 at multiple doses safe for asthmatic patients?
4. 4.Participants will be asked to self-administer two doses per week for a total of 6 weeks (11 doses). A diary on AD17002 usage, adverse events, and reliever medication will be recorded.

Conditions

Eosinophilic Asthma

Keywords

LTh(αK), Type I/III Interferon, Immunomodulator, epithelial

Outcome Measures

Primary Outcomes (1)

• FEV1 improvement

  Lung function tests with spirometry

  Day 1 to Day 78

Secondary Outcomes (10)

• Change to the use of Short-Acting Beta Agonists (SABA)

  Day 1 to Day 78

• Fractional exhaled nitric oxide (FeNO) change

  Day 1 to Day 78

• changes of sputum eosinophil counts

  Day 1 to Day 78

• Asthma Control Test (ACT) scores improvement

  Day 1 to Day 78

• Corticosteroid used to control asthma

  Day 1 to Day 78

Study Arms (4)

Cohort 1 Placebo

PLACEBO COMPARATOR

Formulation buffer

Drug: Placebo

Cohort 1 Low dose

EXPERIMENTAL

Formulation buffer + 10 μg AD17002

Drug: AD17002

Cohort 2 Placebo

PLACEBO COMPARATOR

Formulation buffer

Drug: Placebo

Cohort 2 High dose

EXPERIMENTAL

Formulation buffer + 20 μg AD17002

Drug: AD17002

Interventions

AD17002 DRUG

The dosing days of AD17002 are: Days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32.

Also known as: LTh(αK)

Cohort 1 Low dose; Cohort 2 High dose

Placebo DRUG

Formulation buffer. Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.

Also known as: Formulation buffer

Cohort 1 Placebo; Cohort 2 Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject 20-80 years of age on the day of signing informed consent
• Subject who is not a current smoker with poorly controlled, moderate to severe eosinophilic asthma based on GINA 2022 criteria.
• The subject is diagnosed with asthma.
• Subjects who have the post-bronchodilator reversibility of Forced expiratory volume 1 (FEV1) of ≥ 12% and ≥ 200 mL in response to a SABA at the screening visit or documented in the medical chart within 3 months of the screening visit.
• Subjects who have ≥3% eosinophil counts in the induced sputum within 7 days of Visit 1.
• Subjects with ACT scores ≤ 19 under regular low to moderate-dose inhaled corticosteroids (ICS) and/or a combination with inhaled long-acting beta 2 agonists for at least 3 months before the Screening Visit.
• Have a negative serum pregnancy test at the screening, and randomization visits (female subjects of childbearing potential). A female subject who is of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the trial. Acceptable birth control methods are intrauterine devices, hormonal contraception, diaphragm with spermicide, contraceptive sponge, condoms, and vasectomy, as per local regulations or guidelines.
• A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as one who has either
• Reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea),
• Six weeks postsurgical documented total hysterectomy and/or bilateral salpingo-oophorectomy, or
• Bilateral tubal ligation.
• Subject or the subject's legal representative understands the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent.
• Provide written informed consent for the trial and be willing to adhere to dose and visit schedules.

You may not qualify if:

• Subjects with serious underlying chronic illness or severe systemic disease, including SLE, malignant diseases, uremia and heart failure, or abnormal liver function.
• Subjects without a recent respiratory tract infection within 3 weeks before the study.
• Subjects without a recent COVID-19 infection within 1 month before study.
• Subjects with clinically important lung disease, including but not limited to COPD (Chronic Obstructive Pulmonary Disease), chronic respiratory infection, lung cancer, etc.
• Arrhythmia, myocardial infarction, or stroke in the last 3 months.
• Active COVID-19 disease (SARS-CoV-2 Lateral flow tests (LFA)-positive) at Screening.
• A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized.
• A clinical history of active chronic sinusitis (\> 3 months).
• Any clinically relevant chronic disease (\>=3 months duration) (e.g. cystic fibrosis, malignancy, renal or hepatic insufficiency).
• Subject with a documented history of Bell's palsy.
• The subject has any nasal condition that could confound the efficacy or safety assessments.
• Immunosuppressive treatment (ATC code L04 or L01) within 3 months before the screening visit (except the specified concomitant medications for allergy and asthma symptoms).
• Has unstable or severe asthma, as judged by the clinical Investigator, or a subject who has 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 systemic corticosteroids (but allowing SABA) at any time within the last 3 months before Screening Visit.
• Has asthma requiring high-dose oral corticosteroid (OCS) within the last 3 months before Screening Visit.
• Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen.

Sponsors & Collaborators

• Advagene Biopharma Co. Ltd.: lead
• Taipei Medical University Hospital: collaborator

Study Sites (1)

Taipei Medical University Hospital

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

Study Officials

• Yushen Hsu, Ph.D.

  Advagene Biopharma

  STUDY CHAIR

• Han-Pin Kuo, MD. Ph.D.

  Taipei Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: November 27, 2023
• Primary Completion: January 28, 2025
• Study Completion: April 27, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-04

Locations

TW (1)