UMIN-CTR Clinical Trial

Basic information
Public title	Identification of biomarkers that predict responsiveness to Dupilumab among severe asthma
Acronym	Biomarker for Dupilumab
Scientific Title	Identification of biomarkers that predict responsiveness to Dupilumab among severe asthma
Scientific Title:Acronym	Biomarker for Dupilumab
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 Dupilumab
Basic objectives2	Others
Basic objectives -Others	Clarify effectiveness of Dupilumab 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 Dupilumab 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
Institute	National Hospital Organization Tokyo National Hospital
Institute
Department

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	tsukahara.rie.tz@mail.hosp.go.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
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	No longer recruiting
Date of protocol fixation	2019 Year 03 Month 22 Day
Date of IRB	2019 Year 04 Month 30 Day
Anticipated trial start date	2019 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 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, 2023.

Management information
Registered date	2020 Year 09 Month 28 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044359