Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07214753

A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy

ItAlian, Multicenter, Observational, Prospective sTudy to Evaluate the acHievement of Clinical rEmission and immuNomodulation in Severe Eosinophilic Asthma Patients Treated With Benralizumab - the ATHENA Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
335 (estimated)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.

Detailed description

The ATHENA study aims to expand real-world evidence on benralizumab role in clinical practice, specifically evaluating its effectiveness in achieving clinical remission (complete and partial), as defined by SANI. Additionally, given the growing importance of biomarkers in asthma research, this study seeks to further investigate benralizumab immunological effects, potentially contributing to a deeper understanding of asthma pathophysiology and addressing existing knowledge conundrum. Additionally, the study will consolidate long-term safety data.

Conditions

Interventions

TypeNameDescription
BIOLOGICALbenralizumab30mg s.c. as per SmPC

Timeline

Start date
2025-12-20
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2025-10-09
Last updated
2026-04-09

Locations

28 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT07214753. Inclusion in this directory is not an endorsement.