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Eosinophilic AsthmaPhase 1/2NCT05985694

AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma

A Phase 1/2 study testing AD17002 in people with Eosinophilic Asthma, run by Advagene Biopharma Co. Ltd. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Could the AD17002 intranasal immunomodulator improve the clinical condition of eosinophilic asthmatic patients? 2. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Eosinophilic Asthma
What is being tested?
AD17002
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTaiwan
Study dates
27 Nov 2023to 27 Apr 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Is pregnant or expecting to conceive within the projected duration of the trial.
  • Is nursing at randomization and within the projected duration of the trial?
  • Has had previous exposure to the study drug or Flu Vaccine AD07030.
  • The subject is receiving ongoing treatment with any specific immunotherapy at the time of the Screening Visit.
  • Has a known history of allergy, hypersensitivity, or intolerance to investigational medicinal products, rescue medications, or self-injectable epinephrine.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Medical University Hospital

    Taipei, Taiwan

Other trials in Taiwan

About this study

Official title: A Single-blind (Patient-blind), Randomized, Placebo-controlled, Intranasal Administration Study on Mechanisms and Potential Efficacy of AD17002 in Subjects With Poorly Controlled, Moderate to Severe Eosinophilic Asthma

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

  1. Could the AD17002 intranasal immunomodulator improve the clinical condition of eosinophilic asthmatic patients?
  2. Could patients self-administer AD17002 via the intranasal route?
  3. Is the AD17002 at multiple doses safe for asthmatic patients?
  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.
Read the detailed description

This study was conducted to determine the potential efficacy and mechanism of AD17002 as an immunomodulator in attenuating the severity of clinical manifestations in patients with unstable, moderate-to-severe eosinophilic asthma. Patients with clinical history and ongoing eosinophilic asthma will be randomly assigned to either AD17002 (10 μg or 20 μg) or placebo, per 3-4 days, in a 1:1 ratio, in a single-blinded (patient-blinded) fashion. The nasal administration will be self-administered by participants. Progression and improvement in asthmatic symptoms will be recorded. All study subjects will sign ethics committee-approved informed consent forms before participating in any trial-related activities. Subjects who participate in this trial of AD17002 will provide information about the dosing, efficacy, and safety of the new indication that will guide its future clinical use.

Being tested
AD17002, Placebo
Keywords
LTh(αK), Type I/III Interferon, Immunomodulator, epithelial
Medical subject headings
Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AD17002Drug

    Also called LTh(αK)

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

  • PlaceboDrug

    Also called Formulation buffer

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

Study groups in NCT05985694
Study groupRoleWhat they receive
Cohort 1 PlaceboPlacebo comparatorFormulation buffer
Receives: Drug: Placebo
Cohort 1 Low doseExperimentalFormulation buffer + 10 μg AD17002
Receives: Drug: AD17002
Cohort 2 PlaceboPlacebo comparatorFormulation buffer
Receives: Drug: Placebo
Cohort 2 High doseExperimentalFormulation buffer + 20 μg AD17002
Receives: Drug: AD17002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1 improvement

    Lung function tests with spirometry

    Measured: Day 1 to Day 78

Secondary outcomes (10)

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

    The number of use of rescue Short-Acting Beta Agonists

    Measured: Day 1 to Day 78

  2. Fractional exhaled nitric oxide (FeNO) change

    Change to the FeNO levels

    Measured: Day 1 to Day 78

  3. changes of sputum eosinophil counts

    Change to the induced sputum eosinophils' count

    Measured: Day 1 to Day 78

  4. Asthma Control Test (ACT) scores improvement

    Change to the ACT scores. A maximum score of 25 points indicates complete asthma control. A score between 20 and 25 represents well controlled asthma, while a score of 19 or below represents not well controlled asthma, and a score less than 16 indicates very poorly controlled asthma.

    Measured: Day 1 to Day 78

  5. Corticosteroid used to control asthma

    Numbers of corticosteroid used, inhaled or oral

    Measured: Day 1 to Day 78

  6. Immunological biomarkers of sputum

    Changes in the concentration of sputum IL-4, -5, -13, IFN-α, eosinophil peroxidase (EPO), eosinophil cationic protein (ECP) from the baseline

    Measured: Day 1 to Day 78

  7. Immunological biomarkers of serum

    Change of concentration from baseline of induced serum IL-4, -5, -13

    Measured: Day 1 to Day 78

  8. Peripheral eosinophil count

    Change of cell numbers from baseline of peripheral eosinophil count

    Measured: Day 1 to Day 78

  9. Adverse events_clinical visit

    Clinical visit and check up by physicians

    Measured: Day 1 to Day 36 and Day 78

  10. Adverse events-Diary

    Patient self report adverse events via diary

    Measured: Day 1 to Day 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start27 Nov 2023
  3. Primary completion28 Jan 2025
  4. Study completion27 Apr 2025

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985694
Sponsor's protocol ID
ADV_Asthma_17002-1
Status last verified
Apr 2025
First submitted
26 Jul 2023
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AD17002 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 13 inclusion and 20 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: finished, as of the sponsor's last update on 10 Sep 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 improvement (time frame: Day 1 to Day 78). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05985694.

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 10 Sep 2025.

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