NCT07567690

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Aug 2025Dec 2026

Study Start

First participant enrolled

August 19, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 22, 2026

Last Update Submit

April 30, 2026

Conditions

AsthmaImmunogenicityBiologics

Outcome Measures

Primary Outcomes (2)

  • Annualized rate of clinically significant asthma exacerbations

    Annualized rate of clinically significant asthma exacerbations

    12 month

  • Number of participants experiencing at least one asthma exacerbation

    Number of participants experiencing at least one asthma exacerbation

    12 month

Study Arms (1)

Patients with severe asthma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe asthma

You may qualify if:

  • Patients with severe asthma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06355, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 5, 2026

Study Start

August 19, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

KR(1)