UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052889 |
|---|---|
| Receipt number | R000060349 |
| Scientific Title | Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2023/11/24 12:41:10 |
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Basic information
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
Condition
Severe asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
junmiyata.a2@keio.jp
Public contact
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
junmiyata.a2@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Jun Miyata
Funding Source
Organization
GlaxoSmithKline plc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81333531211
med-nintei-jimu@adst.keio.ac.jp
Secondary IDs
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
Institutions
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
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.
Management information
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/ctr_e/ctr_view.cgi?recptno=R000060349
