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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07567690

Enrollment

100

Registered

2026-05-05

Start date

2025-08-19

Completion date

2026-12-31

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Biologics, Immunogenicity

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with severe asthma

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Annualized rate of clinically significant asthma exacerbations	12 month	Annualized rate of clinically significant asthma exacerbations
Number of participants experiencing at least one asthma exacerbation	12 month	Number of participants experiencing at least one asthma exacerbation

Countries

South Korea

Outcome results