UMIN-CTR Clinical Trial

Basic information
Public title	Biomarkers predictive for clinical efficacy of anti-interleukin-5 receptor alpha monoclonal antibody in patients with asthma
Acronym	Biomarkers foranti-interleukin-5 receptor alpha monoclonal antibody
Scientific Title	Biomarkers predictive for clinical efficacy of anti-interleukin-5 receptor alpha monoclonal antibody in patients with asthma
Scientific Title:Acronym	Biomarkers foranti-interleukin-5 receptor alpha monoclonal antibody
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Biomarkers predictive for clinical efficacy of anti-IL-5 receptor alpha monoclonal antibody in patients with asthma
Basic objectives2	Others
Basic objectives -Others	Biomarkers for clinical efficacy of anti-IL-5 receptor alpha monoclonal antibody in patients with asthma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biomarker discovery for clinical efficacy of anti-IL-5 receptor alpha monoclonal antibody
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	-Subject is diagnosed with asthma according to the Japanese Asthma Prevention and Management Guidelines (JGL). -Participant demonstrates understanding and has provided an appropriately signed and dated informed consent
Key exclusion criteria	Exclusion criteria included COPD, interstitial pneumonia, infectious disease, and active cancer.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Norihiro Middle name Last name Harada
Organization	Juntendo University school of medicine
Division name	Department of respiratory medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1063
Email	nor@juntendo.ac.jp

Public contact
Name of contact person	1st name Norihiro Middle name Last name Harada
Organization	Juntendo University school of medicine
Division name	Department of respiratory medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1063
Homepage URL
Email	nor@juntendo.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
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	Juntendo University Research Ethics Committee
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-3111
Email	chiken@juntendo.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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 26 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	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 23 Day
Date of IRB	2020 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 03 Month 26 Day
Last follow-up date	2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The method of recruitment; Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital by October, 2022.

Management information
Registered date	2018 Year 03 Month 26 Day
Last modified on	2021 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036431

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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