UMIN-ICDS Clinical Trial

Public title

Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment

Acronym

Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment (MEISEA)

Scientific Title

Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment

Scientific Title:Acronym

Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment (MEISEA)

Region

Japan

Condition

Severe asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of our study is to clarify cellular changes of eosinophils and their master regulators, ILC2s, before and after mepolizumab treatment in SEA and identify cellular biomarkers for the evaluation of mepolizumab responders. This study is also aimed to comprehensively understand the role of activated, non-activated, and steady eosinophils in our body.

Basic objectives2

Others

Basic objectives -Others

Evaluation of the effects of the drug on immune cells

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary endpoint is to identify specific cellular changes of eosinophils and ILC2s and their benefit to predict mepolizumab treatment responsiveness.

Key secondary outcomes

Secondary endpoint is to evaluate the molecular differences and similarities of eosinophils and ILC2s between patients after treatment and healthy donors for understanding of cellular reversibility by mepolizumab.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients with severe eosinophilic asthma that is defined as blood eosinophil counts >=150 cells/mm3 at enrollment and/or blood eosinophil counts >=300 cells/mm3 before the study (from the date at diagnosis of asthma to the enrollment date of this study) will be included in this study. They meet all of the following criteria.
The therapeutic management using high-dose ICS (Fluticasone propionate equivalent to >=1000 microg/day or fluticasone furan carboxylic acid equivalent to >=200 microg/day) and >=2 long-term management medicines (LABA, leukotriene receptor antagonist, theophylline, or LAMA).
Male and female between 18 and 80 years of age inclusive
<150 kg at weight.
The patient has provided written informed consent

Healthy volunteers will be included in this study. They meet all of the following criteria.
The one has no history of specific diseases.
Male and female between 18 and 80 years of age inclusive
<150 kg at weight.
The patient has provided written informed consent

Key exclusion criteria

Patients are not eligible for this study if they met any of the following criteria
Has previously been treated with mepolizumab before the study
Has a history of acute viral infection up to 4 weeks prior to blood sampling
Has been treated with systemic corticosteroids including methylprednisolone up to 4 weeks prior to blood sampling
History of widespread lung disease
Has cancer/malignancy under treatment
During the period of pregnancy
Individuals whom the principal investigators judge as inappropriate registers

Healthy volunteers are not eligible for this study if they met any of the following criteria:
Has a history of acute viral infection up to 4 weeks prior to blood sampling
Individuals whom the principal investigators judge as inappropriate registers

Target sample size

40

Name of lead principal investigator

1st name	Jun
Middle name
Last name	Miyata

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine, Department of Medicine

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Email

junmiyata.a2@keio.jp

Name of contact person

1st name	Jun
Middle name
Last name	Miyata

Organization

Keio University School of Medicine

Division name

Division of Pulmonary Medicine, Department of Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Homepage URL

Email

junmiyata.a2@keio.jp

Institute

Keio University

Institute

Department

Personal name

Jun Miyata

Organization

GlaxoSmithKline plc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Boards of Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

+81333531211

Email

med-nintei-jimu@adst.keio.ac.jp

Secondary IDs

YES

Study ID_1

jRCT1031230460

Org. issuing International ID_1

Japan Registry of Clinical Trials

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）

Date of disclosure of the study information

2023

Year

11

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

09

Month

01

Day

Date of IRB

2023

Year

09

Month

01

Day

Anticipated trial start date

2023

Year

11

Month

19

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To evaluate the effect of mepolizumab on cellular properties, the results of multilayer omics analysis of eosinophils and ILC2 before and after treatment will be compared for gene expression and protein contents. The analysis population will be divided into two groups: one group with an improvement of 0.5 or more on the ACQ-5 and the other group with an improvement of 0.5 or more on the ACQ-5.
Gene expression and protein content of eosinophils and ILC2 measured by multilayer omics analysis after mepolizumab treatment will be compared with those of eosinophils in healthy subjects. The effect of anti-IL-5 antibody on normalization of eosinophils and ILC2 will be performed by comparing cellular properties of these cells in healthy subjects and SEA patients before and after anti-IL-5 antibody treatment.

Registered date

2023

Year

11

Month

24

Day

Last modified on

2023

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060349