AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma
Eosinophilic Asthma
About this trial
This is an interventional treatment trial for Eosinophilic Asthma
Eligibility Criteria
Inclusion Criteria: 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. Subject who is diagnosed with asthma, over 2 years of follow-up. 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 2 years of the screening visit. Subjects who have >15% 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. Subjects without a recent respiratory tract infection within 3 weeks prior to the study. Subjects without a recent COVID-19 infection within 3 months prior to study. 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. Be able to understand, and complete questionnaires and diaries. Provide written informed consent for the trial and be willing to adhere to dose and visit schedules. Exclusion Criteria: Subjects with serious underlying chronic illness or severe systemic disease, including SLE, malignant diseases, uremia and heart failure, or abnormal liver function. 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. Has any nasal condition that could confound the efficacy or safety assessments (e.g., severe nasal polyposis) Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to 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 6 months before Screening Visit. Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen. Has a history of chronic urticaria and/or angioedema within the last 2 years before the Screening visit. 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. 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
Sites / Locations
- Taipei Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Cohort 1 Placebo
Cohort 1 Low dose
Cohort 2 Placebo
Cohort 2 High dose
Formulation buffer
Formulation buffer + 10 μg LTh(αK)
Formulation buffer
Formulation buffer + 20 μg LTh(αK)