Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT05985694
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma
Sponsor:
Advagene Biopharma Co. Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: