Nasal spray could tame tough asthma Flare-Ups
NCT ID NCT07250594
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests AD17002, a nasal spray that aims to calm the immune system in people with moderate to severe eosinophilic asthma that is not well controlled by current treatments. About 126 adults will receive either the spray or a placebo for 3 months. Researchers will check if it reduces asthma attacks and is safe to use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AD17002 (an intranasal immunomodulator)
- What this could lead to
- If successful, this could provide a new add-on treatment option to better control moderate to severe eosinophilic asthma and reduce flare-ups.
- What could go wrong
- This is an early Phase 2 trial with only 126 participants, so results may not confirm effectiveness. The treatment is an add-on, not a replacement for current asthma medications.
Why investors are watching
AdvaGene Biopharma is running a phase 2 trial of AD17002, an intranasal spray, as an add-on treatment for adults with moderate to severe eosinophilic asthma that is not well controlled. For a micro-cap company with few products, this readout is a major test of whether its drug works in a large, common disease. A clear result, positive or negative, will shape the company's value and future plans.
If it works: If the trial shows AD17002 safely reduces asthma symptoms or improves control, the company could have a new, self-administered treatment option for a large patient group. That result could support further development and partnerships, which would be a meaningful step for a company of this size.
If it fails: Phase 2 trials often fail to show a benefit, and this one could miss its goals or show safety problems. A negative or unclear result would likely set the program back and could hurt the company's prospects, since it has few other assets to fall back on.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advagene Biopharma
Taipei, Taiwan, Taiwan
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