Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.

Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma. - iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030466

Enrollment

Registered

2017-12-19

Start date

2017-04-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Asthma

Interventions

mepolizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Treated by >= 400 microg/day of inhaled corticosteroids (fluticasone equivalent) with one or more controllers (LABA, LTRA, or theophylline) for more than 3 months 2. Blood eosinophil counts >= 300/microl in previous 12 month or >= 150/microl at first injection 3. Exacerbation history (>=1) in previous 12 month 4. ACQ 5 score >= 0.75

Exclusion criteria

Exclusion criteria: 1. Complicated by pulmonary disease other than asthma 2. Complicated by malignant diseases 3. Diagnosed as hypereosinophilc syndrome or eosinophilic granulomatosis with polyangiitis 4. Administrated omalizumab in previous 30 days

Design outcomes

Primary

Measure	Time frame
The relationship between the levels of candidate biomarkers and improvement in symptom after 32 w treatment.	—

Secondary

Measure	Time frame
1) Divide patients into two groups based on median value of pre-dose biomarkers and compare the effect on ACQ-5 score, exacerbation, and FEV1. 2) Relationship between early change (4 to 12 weeks after first injection) in clinical index and final improvement in ACQ-5 score or exacerbation after 32 weeks. 3) Precise time course of various biomarkers. 4) Effect on rhinosinusitis, atopic dermatitis, and otitis media. 5) Comparison of effect between reversibility positive and negative patients, or, patient with smoking history >= and < 10 pack year.	—

Measure

Time frame

1) Divide patients into two groups based on median value of pre-dose biomarkers and compare the effect on ACQ-5 score, exacerbation, and FEV1. 2) Relationship between early change (4 to 12 weeks after first injection) in clinical index and final improvement in ACQ-5 score or exacerbation after 32 weeks. 3) Precise time course of various biomarkers. 4) Effect on rhinosinusitis, atopic dermatitis, and otitis media. 5) Comparison of effect between reversibility positive and negative patients, or, patient with smoking history >= and < 10 pack year.

—

Countries

Japan

Contacts

Public ContactHiroyuki Nagase

Teikyo University School of Medicine Department of Medicine

nagaseh@med.teikyo-u.ac.jp81-3-3964-8351

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026