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NOT YET RECRUITING
NCT07250594
PHASE2

A Multi-dose Study on the Safety and Efficacy of Self-administered Intranasal AD17002 Treatment for Eosinophilic Asthma

Sponsor: Advagene Biopharma Co. Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-12

Completion Date

2026-12

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

AD17002

The IP, AD17002, will be provided in a container, each containing an appropriate number of IP pre-filled, self-administered syringes. Each container will be labeled as required per local requirements

OTHER

Formulation buffer

The placebo will be provided in a container, each containing an appropriate volume of formulation buffer, pre-filled syringes for self-administration. Each container will be labeled as required per local requirements

Locations (1)

Advagene Biopharma

Taipei, Taiwan, Taiwan