Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985694
Other study ID # ADV_Asthma_17002-1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 27, 2023
Est. completion date September 27, 2024

Study information

Verified date July 2023
Source Advagene Biopharma Co. Ltd.
Contact Mingi Chang, Ph.D.
Phone +886-2-7970073
Email mingi.chang@advagene.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it aims to answer are 1. Could the LTh(αK) intranasal treatment improve the clinical condition of these patients? 2. Could patients self-administrate LTh(αK) via the intranasal route? 3. Is the LTh(αK) at multiple doses safe for asthmatic patients? 4. Participants will be asked to self-administrate two doses per week for a total of 6 weeks (11 doses). A diary on LTh(αK) usage, adverse events, and reliever medication will be recorded.


Description:

Eosinophilic asthma is recognized as a sub-phenotype of asthma based on the pattern of inflammatory cellular infiltration in the airway. Eosinophilic asthma can be associated with increased asthma severity, atopy, late-onset disease, and steroid refractoriness. Induced sputum cell count is the standard for identifying eosinophilic inflammation in asthma and fractional exhaled nitric oxide (FeNO) and serum periostin are emerging as potential surrogates. The Type I and III interferons (IFNs) can negatively regulate the allergic reaction, and their production from mucosal epithelium is reported to be lower in patients with asthma. The investigational intranasal pharmaceutical product named AD17002 contains a detoxified Escherichia coli heat-labile enterotoxin, LTh(αK). Studies have shown that AD17002 enhanced the production of Type I and III IFNs from mucosal epithelial cells. Studies also supported that AD17002 attenuates allergic reactions. The safety and tolerability of LTh(αK) have been demonstrated in several clinical trials as an intranasal adjuvant for influenza vaccine (NCT03293732 and NCT03784885) or an intranasal immunomodulator for respiratory hypersensitivity (NCT04088721) and viral infection (NCT05069610 and NCT05541510). This study is conducted to determine the potential efficacy and mechanism of LTh(αK) 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-administrated 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 27, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subject 20-80 years of age on the day of signing informed consent 2. Subject who is not a current smoker with poorly controlled, moderate to severe eosinophilic asthma based on GINA 2022 criteria. 3. The subject is diagnosed with asthma. 4. 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. 5. Subjects who have =3% eosinophil counts in the induced sputum within 7 days of Visit 1. 6. 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. 7. 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. 8. 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 9. 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), 10. Six weeks postsurgical documented total hysterectomy and/or bilateral salpingo-oophorectomy, or 11. Bilateral tubal ligation. 12. 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. 13. Provide written informed consent for the trial and be willing to adhere to dose and visit schedules. Exclusion Criteria: 1. Subjects with serious underlying chronic illness or severe systemic disease, including SLE, malignant diseases, uremia and heart failure, or abnormal liver function. 2. Subjects without a recent respiratory tract infection within 3 weeks before the study. 3. Subjects without a recent COVID-19 infection within 1 month before study. 4. Subjects with clinically important lung disease, including but not limited to COPD (Chronic Obstructive Pulmonary Disease), chronic respiratory infection, lung cancer, etc. 5. Arrhythmia, myocardial infarction, or stroke in the last 3 months. 6. Active COVID-19 disease (SARS-CoV-2 Lateral flow tests (LFA)-positive) at Screening. 7. A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized. 8. A clinical history of active chronic sinusitis (> 3 months). 9. Any clinically relevant chronic disease (>=3 months duration) (e.g. cystic fibrosis, malignancy, renal or hepatic insufficiency). 10. Subject with a documented history of Bell's palsy. 11. The subject has any nasal condition that could confound the efficacy or safety assessments. 12. Immunosuppressive treatment (ATC code L04 or L01) within 3 months before the screening visit (except the specified concomitant medications for allergy and asthma symptoms). 13. 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. 14. Has asthma requiring high-dose oral corticosteroid (OCS) within the last 3 months before Screening Visit. 15. Has a history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen. 16. Is pregnant or expecting to conceive within the projected duration of the trial. 17. Is nursing at randomization and within the projected duration of the trial? 18. Has had previous exposure to the study drug or Flu Vaccine AD07030. 19. The subject is receiving ongoing treatment with any specific immunotherapy at the time of the Screening Visit. 20. Has a known history of allergy, hypersensitivity, or intolerance to investigational medicinal products, rescue medications, or self-injectable epinephrine.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AD17002
The investigational intranasal pharmaceutical product named AD17002 contains a detoxified Escherichia coli heat-labile enterotoxin, LTh(aK). Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.
Placebo
Formulation buffer. Dosing days: 1, 4, 8, 11, 15, 18, 22, 25, 29, 32.

Locations

Country Name City State
Taiwan Taipei Medical University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
Advagene Biopharma Co. Ltd. Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary FEV1 improvement Lung function tests with spirometry Day 1 to Day 78
Secondary Change to the use of Short-Acting Beta Agonists (SABA) The number of use of rescue Short-Acting Beta Agonists Day 1 to Day 78
Secondary Fractional exhaled nitric oxide (FeNO) change Change to the FeNO levels Day 1 to Day 78
Secondary Sputum eosinophil change Change to the induced sputum eosinophils' count Day 1 to Day 78
Secondary 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. Day 1 to Day 78
Secondary Corticosteroid used to control asthma Numbers of corticosteroid used, inhaled or oral Day 1 to Day 78
Secondary Immunological biomarkers of sputum Changes in the concentration of sputum IL-4, -5, -13, IFN-a, eosinophil peroxidase (EPO), eosinophil cationic protein (ECP) from the baseline Day 1 to Day 78
Secondary Immunological biomarkers of serum Change of concentration from baseline of induced serum IL-4, -5, -13 Day 1 to Day 78
Secondary Peripheral eosinophil count Change of cell numbers from baseline of peripheral eosinophil count Day 1 to Day 78
Secondary Adverse events_clinical visit Clinical visit and check up by physicians Day 1 to Day 36 and Day 78
Secondary Adverse events-Diary Patient self report adverse events via diary Day 1 to Day 78
See also
  Status Clinical Trial Phase
Recruiting NCT05398133 - Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
Recruiting NCT04585997 - Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab". Phase 4
Completed NCT03563521 - Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
Completed NCT03469934 - Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma Phase 2
Enrolling by invitation NCT06388889 - Phase III Long-Term Extension Study With Dexpramipexole Phase 3
Recruiting NCT04187976 - Eosinophils Endotypes in Chronic Airway Inflammatory Diseases
Recruiting NCT05813288 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3) Phase 3
Completed NCT01285323 - A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma Phase 3
Completed NCT03696914 - Intense Airway Eosinophilia in Asthma
Terminated NCT01290887 - Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma Phase 3
Recruiting NCT04228588 - A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil Phase 4
Recruiting NCT05748600 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma Phase 3
Recruiting NCT05763121 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. Phase 3
Completed NCT01508936 - Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma Phase 3
Recruiting NCT04538937 - Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils
Completed NCT05002621 - Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
Completed NCT01270464 - A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma Phase 3
Completed NCT04674137 - XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma Phase 2
Recruiting NCT04671446 - Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma
Completed NCT04046939 - Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma Phase 2