Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT07250594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma
Sponsor:
Advagene Biopharma Co. Ltd.
Organization:
Study Overview
Official Title:
A Phase II, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-dose Study to Investigate the Safety and Efficacy of 3-month AD17002 Treatment in Adults With Inadequately Controlled Moderate to Severe Eosinophilic Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
1. Eosinophilic asthma, a type 2 immune disorder, often involves the excessive production of type 2 cytokines.
2. Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.
3. AD17002 is an intranasal self-applicable immunomodulator.
4. AD17002 is safe and tolerable in all studied clinical trials.
5. AD17002 elevates local type-1 interferon levels and promotes epithelial healing.
6. Type-1 interferons have been demonstrated to restore immune balance and reduce eosinophilic infiltration.
AD17002, an innate immune modulator, is likely to be effective as an add-on therapy to control poorly managed moderate to severe eosinophilic asthma.
2. Excessive Type 2 cytokines lead to chronic inflammation, airway hyperresponsiveness, and airflow obstruction.
3. AD17002 is an intranasal self-applicable immunomodulator.
4. AD17002 is safe and tolerable in all studied clinical trials.
5. AD17002 elevates local type-1 interferon levels and promotes epithelial healing.
6. Type-1 interferons have been demonstrated to restore immune balance and reduce eosinophilic infiltration.
AD17002, an innate immune modulator, is likely to be effective as an add-on therapy to control poorly managed moderate to severe eosinophilic asthma.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: