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

April 30, 2026 updated by: Noeul KANG, Samsung Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 06355
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with severe asthma

Description

Inclusion Criteria:

  • Patients with severe asthma

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with severe asthma

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-05-028
  • SMO1250661 (Other Grant/Funding Number: Samsung Medical Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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