UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030466
Receipt number R000034785
Scientific Title Identification of prediction marker for efficacy of anti-IL-5 antibody and observation of time course of biomarkers in asthma.
Date of disclosure of the study information 2017/12/19
Last modified on 2021/07/31 06:54:13

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Basic information

Public title

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

Acronym

iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers

Scientific Title

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

Scientific Title:Acronym

iPOT-5 study: anti-iL-5 Ab: Prediction of efficacy and Observation of Time course of biomarkers

Region

Japan


Condition

Condition

Asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Anti-IL-5 antibody (Ab) has been approved for molecular targeted therapy for asthma. Previous studies consistently showed that anti-IL-5 Ab suppressed the frequency of exacerbation and blood eosinophil count was identified as an important marker for prediction of efficacy. Although, asthma symptom or pulmonary function was not consistently improved by treatment and prediction markers for those index have not been established yet.
The aim of this study is to establish prediction marker for improvement in symptom or pulmonary function. To do this, we analyze the relationship between potential biomarkers other than eosinophils and improvement in symptom or pulmonary function.
In addition, we will also analyze, 1) the efficacy for chronic rhinosinusitis with nasal polyps, 2) the efficacy for reversibility negative patients, who was excluded in previous clinical trials, and 3) precise time course of various clinical index and biomarkers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

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

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

mepolizumab

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Nagase

Organization

Teikyo University School of Medicine

Division name

Department of Medicine

Zip code

1738605

Address

1738605 Kaga 2-11-1, Itabashi-ku, Tokyo, Japan

TEL

81-3-3964-8351

Email

nagaseh@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Nagase

Organization

Teikyo University School of Medicine

Division name

Department of Medicine

Zip code

1736605

Address

1738605 Kaga 2-11-1, Itabashi-ku, Tokyo, Japan

TEL

81-3-3964-8351

Homepage URL


Email

nagaseh@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects

Address

2-11-1 Kaga, Itabashi-ku, Tokyo 173-0003 Japan

Tel

03-3964-7256

Email

turb-office@teikyo-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

NTT東日本関東病院 (東京都)、慶應義塾大学病院 (東京都)、順天堂大学医学部付属順天堂江東高齢者医療センター (東京都)、昭和大学病院 (東京都)、帝京大学医学部附属病院 (東京都)、東京女子医科大学病院 (東京都)、日本大学医学部附属板橋病院 (東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 19 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034785

Publication of results

Published


Result

URL related to results and publications

https://apallergy.org/DOIx.php?id=10.5415/apallergy.2021.11.e31

Number of participants that the trial has enrolled

20

Results

The serum galectin-10 and ECP significantly decreased 4 weeks after mepolizumab initiation. In contrast, basophil count, FeNO, and the serum total IgE level were unchanged. ACQ-5, AHQ-33, and Lund-Mackay scores also significantly improved . Both high ECP and eosinophil count related to better response in FEV1 and measurable ECP level at 4 weeks after administration of mepolizumab related to the further improvement in FEV1 toward week 32.

Results date posted

2021 Year 07 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 07 Month 10 Day

Baseline Characteristics

We included patients with a score of at least 0.75 in ACQ5 during treatment comprising at least 400 microg of fluticasone propionate or the equivalent by inhalation per day and at least 3 months of treatment with an additional controller; those who experienced at least one occurrence of asthma exacerbation that required more than 3 days of systemic corticosteroids, Emergency Department visit, or an admission in the previous year; and blood eosinophil count of at least 150 cells per microL at screening or at least 300 cells per microL at some time during the previous year. Patients with past smoking history were included, and presence of FEV1 reversibility was not necessary.

Participant flow

Mepolizumab was administered every 4 weeks for 32 weeks and the levels of various biomarkers were serially analyzed.

Adverse events

None

Outcome measures

At each visit, patients recorded scores of ACQ-5, Asthma Control Test (ACT), and Asthma Health Questionnaire (AHQ)-33 [8], to estimate their quality of life (QoL) and underwent hematologic tests. Pulmonary function testing and measurement of fractional exhaled nitric oxide (FeNO) by NIOX VERO (Circassia AB, Uppsala, Sweden) were performed before starting mepolizumab (week 0) and after 4, 12, and 32 weeks. Airway reversibility was defined as positive when FEV1 increase 200 mL and 12% after inhalation of bronchodilator. Computed tomography (CT) scans of paranasal sinuses were evaluated prior to the first injection of mepolizumab and at 12 and 32 weeks.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 28 Day

Date of IRB

2017 Year 04 Month 28 Day

Anticipated trial start date

2017 Year 04 Month 29 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 01 Month 31 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 19 Day

Last modified on

2021 Year 07 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034785


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name