UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041914
Receipt number R000044358
Scientific Title Identification of biomarkers that predict responsiveness to Benralizumab among severe asthma
Date of disclosure of the study information 2020/09/28
Last modified on 2022/06/01 16:19:31

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Basic information

Public title

Identification of biomarkers that predict responsiveness to Benralizumab among severe asthma

Acronym

Biomarker for Benralizumab

Scientific Title

Identification of biomarkers that predict responsiveness to Benralizumab among severe asthma

Scientific Title:Acronym

Biomarker for Benralizumab

Region

Japan


Condition

Condition

Asthma

Classification by specialty

Medicine in general Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Identification of biomarkers that predict responsiveness to Benralizumab

Basic objectives2

Others

Basic objectives -Others

Clarify effectiveness of Benralizumab among severe asthma.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationships between a change in GETE and serum cytokine levels

Key secondary outcomes



Base

Study type

Observational


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patient with severe asthma
2. Patient going to use Benralizumab
3. Patient using high dose ICS and other control agents

Key exclusion criteria

Patient whom the researchers think is not suitable for the study.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Maho
Middle name
Last name Suzukawa

Organization

National Hospital Organization Tokyo National Hospital

Division name

Clinical Research Center

Zip code

204-8585

Address

3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan

TEL

042-491-2111

Email

fueta-tky@umin.ac.jp


Public contact

Name of contact person

1st name Maho
Middle name
Last name Suzukawa

Organization

National Hospital Organization Tokyo National Hospital

Division name

Clinical Research Center

Zip code

204-8585

Address

3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan

TEL

042-491-2111

Homepage URL


Email

fueta-tky@umin.ac.jp


Sponsor or person

Institute

National Hospital Organization Tokyo National Hospital

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Tokyo National Hospital

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

Institutional Ethics Review Board of National Hospital Organization Tokyo National Hospital

Address

3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan

Tel

042-491-2111

Email

goto-yumiko@tokyo-hosp.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



Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 28 Day


Related information

URL releasing protocol

https://www.tandfonline.com/doi/abs/10.1080/02770903.2021.1942039?journalCode=ijas20

Publication of results

Unpublished


Result

URL related to results and publications

https://www.tandfonline.com/doi/abs/10.1080/02770903.2021.1942039?journalCode=ijas20

Number of participants that the trial has enrolled

20

Results

There were nine respondents and eight non-respondents. The non-responders showed significantly higher baseline serum interferon-g; interleukin (IL)-4, -5, -6, -7, and -12p70; IL-17/IL-17A; IL-17E/IL-25; IL-18/IL-1F4; chemokine (C-C motif) ligand (CCL)3/macrophage inflammatory protein (MIP)-1a; CCL4/MIP-1b; CCL11/eotaxin; matrix metalloproteinase-12; tumor necrosis factor-a, and thymic stromal lymphopoietin levels.

Results date posted

2022 Year 06 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Seventeen benralizumab-treated patients with severe eosinophilic asthma were enrolled.

Participant flow

Blood samples were collected; pulmonary function tests were performed and questionnaires were disseminated at baseline and after 1, 2, 4, and 6 months of treatment. Blood cytokine levels were measured. Response was defined as an elevation in forced expiratory volume in 1 s of at least 10.4% from baseline after 4 months of treatment.

Adverse events

N.A.

Outcome measures

Cytokine levels of responders at baseline.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB

2018 Year 05 Month 30 Day

Anticipated trial start date

2018 Year 05 Month 30 Day

Last follow-up date

2020 Year 08 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study will end at March, 31, 2021.


Management information

Registered date

2020 Year 09 Month 28 Day

Last modified on

2022 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044358


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name