Real-world Immunogenicity of Anti-IL5/5a Antibody

This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Biologics Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunogenicity Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06355, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with severe asthma

Exclusion criteria

History of hypersensitivity reactions to biologics (anti IL5 or IL5Ra)

Treatment and study plan

Primary outcomes

Annualized rate of clinically significant asthma exacerbations

Time frame: 12 month

Annualized rate of clinically significant asthma exacerbations
Number of participants experiencing at least one asthma exacerbation

Time frame: 12 month

Number of participants experiencing at least one asthma exacerbation

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

A Prospective Observational Study of Biologic Treatment and Outcomes in Patients With Severe Asthma (BREATH)

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 5, 2026
Registry last updated: May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting